Side Effects Of Prostate Biopsy

C O N T E N T S:


  • Whatever the screening modality, the screening process itself can lead to psychological effects in men who have a prostate biopsy but do not have prostate cancer.(More…)
  • Pinsky PF, Andriole GL, Kramer BS, et al.: Prostate biopsy following a positive screen in the prostate, lung, colorectal and ovarian cancer screening trial.(More…)
  • The Gleason score is an important prognostic measure relying on the pathologic assessment of the architectural growth patterns of prostate biopsy.(More…)
  • Prostate surgeries and radiation treatment have far more severe side effects.(More…)
  • The shift is sharply reducing unnecessary treatment that can cause serious side effects including incontinence and sexual problems, experts say, without increasing the risk of death.(More…)
  • One of the main causes of prostate bleeding is prostate cancer so you should always take any concerns about prostate-bleeding or rectal bleeding to your doctor immediately for a possible prostate biopsy.(More…)


  • Prorok PC, Andriole GL, Bresalier RS, et al.: Design of the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.(More…)
  • High-grade PIN is not cancer but may predict an increased risk of prostate cancer.(More…)
  • Unlike the above reports, the Prostate Intervention Versus Observation Trial (PIVOT), the only such randomized study performed in screened men, showed no statistically significant difference between radical prostatectomy and watchful waiting with respect to either all-cause mortality (47% versus 49.9%, respectively) or prostate cancer-specific mortality (5.8% versus 8.4%, respectively) after a median follow-up of 10 years.(More…)
  • A total of 199 men (8%) presented with PSA levels higher than 3.0 ng/mL, which was the study PSA cutoff for recommending a biopsy.(More…)
  • For patients with small volume, non aggressive disease, AS holds out the attraction of deferring treatment while monitoring their PCa by means of PSA blood tests at regular intervals, imaging with multiparametric MRI (mpMRI), and targeted biopsy if indicated by PSA and mpMRI. They and their doctors determine in advance what clinical factors will “trigger” definitive treatment.(More…)


Side Effects Of Prostate Biopsy
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description: Prostate biopsy: What happens, how to prepare, and risks


Whatever the screening modality, the screening process itself can lead to psychological effects in men who have a prostate biopsy but do not have prostate cancer. [1] Based on solid evidence, current prostate cancer treatments, including radical prostatectomy and radiation therapy, result in permanent side effects in many men. [1] Our multidisciplinary team of experts provides the safest, most effective therapies to treat your prostate cancer, while minimizing the side effects of treatment. [2] Interventions that may have no effect on prostate cancer course and may have harmful side effects. [1]

Pinsky PF, Andriole GL, Kramer BS, et al.: Prostate biopsy following a positive screen in the prostate, lung, colorectal and ovarian cancer screening trial. [1] One study screened 14,209 white and 1,004 African American men for prostate cancer using an upper limit of normal of 2.5 ng/mL for PSA. A major confounding factor of this study was that only 40% of those men in whom a prostate biopsy was recommended actually underwent biopsy. [1] The PCPT requested that all men undergo prostate biopsy at study end to address ascertainment bias ; the sensitivity of DRE for prostate cancer was 16.7%. [1]

For individuals who have had at least one negative prostate biopsy but who are thought to be at higher risk for prostate cancer (increasing PSA), the NCCN recommends %fPSA, PHI, 4Kscore, PCA3, and ConfirmMDx. [3] In a definitive analysis of the Prostate Cancer Prevention Trial (PCPT) data, in which full ascertainment was attempted, regardless of PSA value, PSA velocity added no independent value to the prediction of prostate cancer after adjustment for family history, age, race/ethnicity, PSA, and history of prostate biopsy. [1] Prostate cancer is diagnosed by digital rectal exam, prostate specific antigen (PSA) test, and prostate biopsy. [3]

Makhlouf AA, Krupski TL, Kunkle D, et al.: The effect of sampling more cores on the predictive accuracy of pathological grade and tumour distribution in the prostate biopsy. [1] Improving the screening of men prior to prostate biopsy is needed to reduce unnecessary procedures. [4] After a PSA finding greater than 4.0 ng/mL, within 1 year only 41% of men underwent prostate biopsy ; within 3 years of this finding, only 64% of men underwent prostate biopsy. [1] Among these men, 11% of men had a PSA level between 3 ng/mL and 19.9 ng/mL (eligible for the ProtecT trial); of whom, 85% of men had a prostate biopsy. [1] This is based on the fact that only about 20% of men who undergo prostate biopsy will have a 7 or higher Gleason score. [3] A recent study published in the NEJM, carried out a multi-centre clinical trial to evaluate the effectiveness of MRI as a pre-screening tool for subsequent prostate biopsy. [4] Loeb S, Vellekoop A, Ahmed HU, et al.: Systematic review of complications of prostate biopsy. [1] Lefkowitz GK, Sidhu GS, Torre P, et al.: Is repeat prostate biopsy for high-grade prostatic intraepithelial neoplasia necessary after routine 12-core sampling? Urology 58 (6): 999-1003, 2001. [1] Fowler FJ Jr, Barry MJ, Walker-Corkery B, et al.: The impact of a suspicious prostate biopsy on patients’ psychological, socio-behavioral, and medical care outcomes. [1]

Rosario DJ, Lane JA, Metcalfe C, Donovan JL, Doble A, et al. Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study. [5]

It enables a cancer patient to limit the risk of unwanted side effects commonly associated with radiation treatments. [6] Rather than simply listing the potential side effects of each intervention, patients are likely to benefit from being given the odds of developing each complication and the odds that the treatment will result in recurrence of cancer, reduce the development of metastases, and improve overall survival. [5] As such, IMRT may simultaneously boost a cancer patient’s chances of achieving positive results and reducing his or her risk of encountering unwanted side effects. [6]

If the doctor doesn?t do a biopsy during the test, most people won?t experience any side effects. [7]

The Gleason score is an important prognostic measure relying on the pathologic assessment of the architectural growth patterns of prostate biopsy. [1] The standard approach for grading prostate cancer depends on a Gleason score, which is based on pathologic evaluation of a prostatectomy specimen and is commonly estimated from prostate biopsy tissue. [5] Transrectal ultrasound-guided prostate biopsy is the standard method for pathological diagnosis of prostate cancer and is one of the most common urological procedures performed around the world. [8] Cornelis F, Rigou G, Le Bras Y, et al. Real-time contrast-enhanced transrectal US-guided prostate biopsy: diagnostic accuracy in men with previously negative biopsy results and positive MR imaging findings. [5]

Prostate surgeries and radiation treatment have far more severe side effects. [9] Surgery for prostate cancer, as well as other types of prostate cancer treatment, contains a risk of side effects. [10] Many men are well aware of the physical side effects of prostate cancer, which can include issues like urinary incontinence, erectile dysfunction (ED), and bowel problems. [11] We spoke with James Eastham, Chief of Memorial Sloan Kettering’s Urology Service, about different ways of performing prostate cancer surgery, the side effects that may be involved, and the importance of having an experienced surgeon do the procedure. [12]

SpaceOAR hydrogel acts as a protective spacer between the prostate and the rectum and has been clinically proven to reduce the risk of side effects (such as bowel toxicity, urinary incontinence, and erectile dysfunction) during and after radiation treatment. [13] Prostate Hematuria is almost always caused by a greater infection or illness and is one of the common side effects of Prostatic Hyperplasia or a condition that causes the prostate to become enlarged. [14]

The shift is sharply reducing unnecessary treatment that can cause serious side effects including incontinence and sexual problems, experts say, without increasing the risk of death. [15] By using MRI scans, a doctor can simultaneously administer the highest-possible radiation dose to a patient and limit his or her of risk of unwanted side effects. [16] The invention enables simultaneous topical application of a set of antibiotics, which can broaden the spectrum of antimicrobial protection, with a lower risk of side effects. [8] Some serious side effects are possible, and it is important to discuss the risks and any existing health conditions with the doctor. [17] Brachytherapy results in fewer side effects and a shorter treatment time in comparison to external beam radiation. [16] Awareness and treatment of the various side effects of this therapy are important for a man’s quality of life and for reducing the morbidity of this therapy. [5] Intermittent androgen suppression has been assessed in prospective, randomized studies as a possible means of minimizing the side effects of ADT. Crook et al found that intermittent androgen suppression was noninferior to continuous therapy with respect to overall survival. [5]

Treatment of these less aggressive cancers, although curative, left men with unwanted side effects of treatment, such as erectile and urinary difficulties. [18]

An elevated PSA does not always indicate the presence of cancer, yet may trigger the need for a prostate biopsy and expose a patient to the potential risks of pain, infection and bleeding only to find that no cancer exists. [18] Here too, no studies have proved that there is a benefit to performing a prostate biopsy unless the PSA begins to rise and the patient is considered a candidate for salvage prostatectomy. [5] Patients undergoing prostate biopsy are exposed to urinary tract infections, prostatitis, and even severe septic complications. [8] The known prostate biopsy needle does not allow to overcome the problem of hematuria, hematospermia and infectious complications which occur as a result of transrectal invasive procedures of prostate biopsy. [8] The most serious clinical problems are infectious complications occur after the prostate biopsy. [8]

This study conformed to the Standards of Reporting for MRI-Targeted Biopsy Studies consortium criteria for MRI biopsy studies 17 and adhered to the Standards for Reporting of Diagnostic Accuracy ( STARD ) reporting guideline criteria. 18 The study inclusion criteria required all men to have clinical suspicion of prostate cancer (PSA ?4 ng/mL and/or abnormal digital rectal examination results) that warranted a diagnostic prostate biopsy. [19]

Besides holding off on treatment with its risks of urinary and sexual side effects, AS provides time and imaging for a doctor to become familiar with the patient and his cancer, which will help with choosing a treatment when the time comes. [20] Although urologists from the United States perform the procedure in Mexico and the Dominican Republic, patients should be counseled that the cure rates with this technique have not been proved, nor has the incidence of side effects been determined. [5] This treatment can lead to other side effects including impotence and incontinence. [21] Gastrointestinal and cardiovascular side effects were more common in the group receiving docetaxel, however. [5] While, simultaneous use of multiple antibiotics in prophylaxis can result in significant side effects. [8]

We continue to look for ways to further minimize the risk of side effects. [12] In our clinical studies, the most common side effects reported were mild to moderate and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge. [22] Treatment can also cause side effects, like urinary, sexual, and bowel problems. [23] One type of radiation therapy, called brachytherapy (BRAY-kee-THER-uh-pee), has fewer side effects than other types. [23]

One of the main causes of prostate bleeding is prostate cancer so you should always take any concerns about prostate-bleeding or rectal bleeding to your doctor immediately for a possible prostate biopsy. [14] Since a transrectal ultrasound often does not discover anything significantly different than a DRE or PSA test does, its use is often indicated mainly as a guide for a prostate biopsy to help pinpoint suspicious areas. [10] The advisory panel noted drawbacks to the screening, including the potential for false-positives that require additional testing, such as prostate biopsy, overdiagnosis, overtreatment and complications that can include incontinence and erectile dysfunction. [24]

They would rather face the side effect risks of prostatectomy or radiation than hang in with AS. [20] This means you are at risk for a hormone imbalance and all of their negative side effects, which can affect your health from your sex drive, energy levels, mood stability, and more. [14] Treatment can cause major side effects, including erectile dysfunction and urinary incontinence. [25]


Prorok PC, Andriole GL, Bresalier RS, et al.: Design of the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. [1] The PLCO Cancer Screening Trial is a multicenter, randomized, two-armed trial designed to evaluate the effect of screening for prostate, lung, colorectal, and ovarian cancers on disease-specific mortality. [1]

If my biopsy shows some cancer cells, what does that mean? Ask about all treatment options: close monitoring and follow-up visits, radiation, or surgery to remove the prostate. [26] Special reference to cancer of the gastrointestinal tract, prostate, breast, and female generative tract. [1] Differentiation refers to how “normal” a cancer cell appears under a microscope when compared to a normal prostate cell. [27]

Approximately 44% of the men in each study group had undergone one or more PSA tests at baseline, which would have eliminated some cancers detectable on screening from the randomly assigned population; thus, the cumulative death rate from prostate cancer at 10 years in the two groups combined was 25% lower in those who had undergone two or more PSA tests at baseline than in those who had not been tested. [1] One Swedish study found that in the first year after a diagnosis of prostate cancer, the risk of death from cardiovascular disease (CVD) was increased in men diagnosed with prostate cancer compared with men who were not diagnosed with prostate cancer (relative risk, 1.9; 95% confidence interval, 1.9-2.0; adjusted for age, calendar time period, and time since diagnosis). [1] In the first year after diagnosis, the risk of committing suicide was higher for men who had been diagnosed with prostate cancer (RR, 2.6; 95% CI, 2.1-3.0; adjusted for age, calendar time period, marital status, educational level, and history of psychiatric hospitalization). [1] Despite the poor performance of DRE, a retrospective case-control study of men in Olmsted County, Minnesota, who died of prostate cancer found that case patients were less likely to have undergone DRE during the 10 years before diagnosis of prostate cancer (OR, 0.51; 95% CI, 0.31-0.84). [1] A Swedish retrospective study of a nationwide cohort of patients with localized prostate cancer aged 70 years or younger reported that 10-year prostate cancer-specific mortality was 2.4% among men diagnosed with clinically local stage T1a, T1b, or T1c, with a serum PSA of less than 10 ng/mL, and with a Gleason score of 2 to 6, referred to as low-risk cases, of which there were 2,686. [1]

A second trial done in the PSA screening era, the ProtecT study, randomly assigned 1,643 men with localized prostate cancer equally to active monitoring, surgery, or radiation therapy. [1] With serial annual screening in the PLCO cancer screening trial, 8% of men with baseline PSA lower than 1 ng/mL had a prostate cancer diagnosis within 2 years. [1]

The PCA3 gene assay was approved by the U.S. Food and Drug Administration in early 2012, with the intended use to aid in the decision for repeat biopsy in men with a previous negative biopsy for an elevated PSA and for whom a repeat biopsy is being considered for a persistently elevated PSA. This test is performed on a urine sample collected after an attentive DRE (several strokes applied firmly to the prostate to the right and left prostatic lobes ). [1] In a study that examined the magnitude of prostate cancer risk associated with specific factors across the Selenium and Vitamin E Cancer Prevention Trial (SELECT) and Prostate Cancer Prevention Trial cohorts, the authors demonstrated that the likelihood of undergoing screening and biopsy depends on certain known or suspected risk factors. [1] The authors explained that the labeling of a random characteristic such as blue eyes as a risk factor may increase biopsy rates among men with blue eyes, resulting in detection of indolent prostate cancer and leading to the inaccurate conclusion that blue eyes are a risk factor for prostate cancer. [1]

Rietbergen JB, Kruger AE, Kranse R, et al.: Complications of transrectal ultrasound-guided systematic sextant biopsies of the prostate: evaluation of complication rates and risk factors within a population-based screening program. [1] While the authors caution that an optimal prostate screening frequency cannot be determined from these data, they conclude that among men who choose to be screened, these data may provide a context for determining a PSA screening schedule. [1] Matikainen MP, Schleutker J, Msky P, et al.: Detection of subclinical cancers by prostate-specific antigen screening in asymptomatic men from high-risk prostate cancer families. [1] Schrer FH, Hugosson J, Roobol MJ, et al.: Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. [1] Risk of prostate cancer mortality in the European Randomized Study of Screening for Prostate Cancer (ERSPC) by study center at up to 13 years of follow-up in screened versus control arms. [1] Figure 1 shows the risk of prostate cancer death associated with PSA-based screening, compared with controls for up to 13 years of follow-up for each of the study centers in the ERSPC for which data are currently available. [1] With follow-up extended to 18 years in the screening group, 79 men died of prostate cancer (0.98% cumulative mortality) compared with 122 prostate cancer deaths in the control group (1.5% cumulative mortality), a 35% relative reduction. [1] Lodding P, Aus G, Bergdahl S, et al.: Characteristics of screening detected prostate cancer in men 50 to 66 years old with 3 to 4 ng. [1] Smith DS, Carvalhal GF, Mager DE, et al.: Use of lower prostate specific antigen cutoffs for prostate cancer screening in black and white men. [1] Men with one or more risk factors for prostate cancer should consult with their physician about whether to start routine screening earlier. [28] Carlsson S, Sandin F, Fall K, et al.: Risk of suicide in men with low-risk prostate cancer. [1] Men with low-grade prostate cancers had a minimal risk of dying from prostate cancer during 20 years of follow-up (Gleason score of 2 to 4; six deaths per 1,000 person-years; 95% CI, 2-11). [1] After 7 years of follow-up, with vital status known for 98% of men, the incidence of prostate cancer per 10,000 person-years was 116 (2,820 cancers ) in the screening group and 95 (2,322 cancers) in the control group (rate ratio, 1.22; 95% confidence interval, 1.16-1.29). [1] Among 10,523 men randomly assigned to screening, it was reported that the overall prostate cancer detection rate using PSA, DRE, and transrectal ultrasound (TRUS) was 4.5% compared with only 2.5% if DRE alone had been used. [1] Of the seven countries included in the study, only two countries reported a mortality benefit associated with prostate cancer screening (the Netherlands and Sweden), and it is not readily apparent which factors at these two sites (e.g., PSA thresholds or intervals between testing used, mean age of patients) might explain the observed difference. [1] Most men in this study were screened with DRE rather than PSA. All four of these case-control studies are consistent with a reduction of 20% to 30% in prostate cancer mortality. [1] Men with a positive PSA test diagnosed with clinically localized prostate cancer were recruited to the Prostate Testing for Cancer and Treatment (ProtecT) study for treatment. [1] Men who have had a radical prostatectomy (RP) and who subsequently have a recurrence of prostate cancer fare better if they undergo salvage radiation treatment plus antiandrogen therapy instead of radiation alone, according to a 2017 study in The New England Journal of Medicine. [29] A U.S. cohort study explored the association between prostate cancer diagnosis and CVD mortality or suicide in men diagnosed with prostate cancer compared with population-level expected rates during three different time periods (preprostate-specific antigen, peri-PSA, and post-PSA). [1] For CVD mortality, the standardized mortality ratio (SMR) was elevated for men diagnosed with prostate cancer in the first month after diagnosis in all time periods (overall SMR, 2.05; 95% CI, 1.89-2.22), but decreased in later months during the first year (decreasing to <1.0 in the PSA time period). [1] Data from 577 men diagnosed with prostate cancer as a consequence of periodic screening between 1994 and 2007 at a mean age of 66.3 years in four participating clinical centers in the Netherlands, Sweden, and Finland were evaluated. [1] Andriole GL, Crawford ED, Grubb RL 3rd, et al.: Prostate cancer screening in the randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial: mortality results after 13 years of follow-up. [1] Pinsky PF, Prorok PC, Yu K, et al.: Extended mortality results for prostate cancer screening in the PLCO trial with median follow-up of 15 years. [1]

Prostate cancer mortality data after 13 years of follow-up continued to show no reduction in mortality resulting from prostate cancer screening with PSA and DRE. Organized screening in the intervention group of the trial did not produce a mortality reduction compared with opportunistic screening in the usual care group. [1]

A 10-year prostate cancer-specific mortality of 2.4% among patients with low-risk prostate cancer in the surveillance group suggested that surveillance may be a suitable treatment for many patients with low-risk disease compared with the 19.2% 10-year risk of death from competing causes observed in the surveillance group and 10.2% in the curative-intent group of the total 6,849 person cohort. [1] Fang F, Keating NL, Mucci LA, et al.: Immediate risk of suicide and cardiovascular death after a prostate cancer diagnosis: cohort study in the United States. [1] Fall K, Fang F, Mucci LA, et al.: Immediate risk for cardiovascular events and suicide following a prostate cancer diagnosis: prospective cohort study. [1]

One study of these men at 12 months after their negative biopsy who reported worrying that they may develop cancer ( P <.001), showed large increases in prostate-cancer worry compared with men with a normal PSA (26% vs. 6%). [1] The findings showed that the approach of MRI with or without targeted biopsy reduced the number of men that were referred for biopsy, improved the precision of targeted sampling of pathological cores, identified a higher number of men with clinically significant cancer, and reduced the number of men diagnosed with a non-life threatening cancer. [4] The 4Kscore test predicts the risk percent score from less than 1% to greater than 95% of a man having aggressive cancer in a prospective biopsy. [3] Differential screening and biopsy can result in spurious conclusions regarding risk factors for prostate cancer. [1] Past and current screening and biopsy practices may misrepresent prostate cancer risk factors. [1] Such lower biopsy rates, associated with lower prostate cancer detection rates, may have blunted the impact of screening on mortality. [1] Using a threshold value of 60, this test enhances the detection of prostate cancer while reducing the number of biopsies in men who are expected to ultimately have a negative biopsy. [1]

At a minimum, men should be informed about the possibility that false-positive or false-negative test results can occur, that it is not known whether regular screening will reduce the number of deaths from prostate cancer, and that among experts, the recommendation to screen is controversial. [1] Thompson IM, Ernst JJ, Gangai MP, et al.: Adenocarcinoma of the prostate: results of routine urological screening. [1] Brawer MK, Chetner MP, Beatie J, et al.: Screening for prostatic carcinoma with prostate specific antigen. J Urol 147 (3 Pt 2): 841-5, 1992. 92167429. [1] Schrer FH, Roobol-Bouts M, Vis AN, et al.: Prostate-specific antigen-based early detection of prostate cancer–validation of screening without rectal examination. [1] The Prostate Intervention Versus Observation Trial (PIVOT) was the first trial conducted in the PSA screening era that directly compared radical prostatectomy with watchful waiting. [1] Routine screenings in the form of digital rectal exams (DRE) and prostate specific androgen (PSA) tests are important. [28]

Learn causes, symptoms, treatments, and diagnosis as well as little-known facts about the prostate, and what happens to men when the prostate is enlarged. [3] Benign prostatic hyperplasia (BPH or enlarged prostate) is very common in men over 50 years of age. [3] An autopsy study of white and Asian men also found an increase in occult prostate cancer with age, reaching nearly 60% in men older than 80 years. [1] Zlotta AR, Egawa S, Pushkar D, et al.: Prevalence of prostate cancer on autopsy: cross-sectional study on unscreened Caucasian and Asian men. [1] Weinmann S, Richert-Boe K, Glass AG, et al.: Prostate cancer screening and mortality: a case-control study (United States). [1] Richert-Boe KE, Humphrey LL, Glass AG, et al.: Screening digital rectal examination and prostate cancer mortality: a case-control study. [1] Jacobsen SJ, Bergstralh EJ, Katusic SK, et al.: Screening digital rectal examination and prostate cancer mortality: a population-based case-control study. [1] Another case-control study examining screening with both DRE and PSA found a reduction in prostate cancer mortality that was not statistically significant (odds ratio, 0.7; 95% CI, 0.46-1.1). [1] In the European Study on Screening for Prostate Cancer, it was found that if DRE is used only for a PSA higher than 1.5 ng/mL (thus, no DRE is performed with PSA <1.5 ng/mL), 29% of all biopsies would be eliminated while maintaining a 95% prostate cancer detection sensitivity. [1] Because most prostate cancers that are detected today with PSA screening are not palpable, this study may not be directly generalizable to the average newly diagnosed patient in the United States. [1] Improvement in therapy for prostate cancer during the course of the trial may have resulted in fewer prostate-cancer deaths in the two study groups, which blunted any potential benefits of screening. [1] PSA-based screening was reported to reduce the rate of death from prostate cancer by about 20% but was associated with a high risk of overdiagnosis. [1] Men with tumors that had a Gleason score of 5 or 6 had an intermediate risk of prostate cancer death. [1] Men with a family history of prostate cancer are at an increased risk of the disease compared with men without this history. [1] This management approach is most often recommended for men who have very-low- to low-risk prostate cancers (favorable risk) that are believed to be small volume, especially older men whose cancers are unlikely to become life-threatening during the remaining years of their life. [29] Older men, African-American men, and men who have a family history of prostate cancer have a greater risk for developing prostate cancer. [26] Any potential benefits derived from screening asymptomatic men need to be weighed against the harms of screening and diagnostic procedures and treatments for prostate cancer. [1] In the Prostate Testing for Cancer and Treatment (ProtecT) study, 1,643 men with localized prostate cancer were randomly assigned equally to active monitoring, surgery, or radiation therapy. [1] Contrary to these findings, results from a case-control study of 150 men who ultimately died of prostate cancer were compared with 299 controls without disease. [1] Carter HB, Pearson JD, Waclawiw Z, et al.: Prostate-specific antigen variability in men without prostate cancer: effect of sampling interval on prostate-specific antigen velocity. [1] Stenner J, Holthaus K, Mackenzie SH, et al.: The effect of ejaculation on prostate-specific antigen in a prostate cancer-screening population. [1]

The ERSPC was initiated in the early 1990s to evaluate the effect of screening with PSA testing on death rates from prostate cancer. [1]

Perron L, Moore L, Bairati I, et al.: PSA screening and prostate cancer mortality. [1] Sandblom G, Varenhorst E, Rosell J, et al.: Randomised prostate cancer screening trial: 20 year follow-up. [1] Kilpelnen TP, Tammela TL, Malila N, et al.: Prostate cancer mortality in the Finnish randomized screening trial. [1] Labrie F, Candas B, Cusan L, et al.: Screening decreases prostate cancer mortality: 11-year follow-up of the 1988 Quebec prospective randomized controlled trial. [1] Mtten L, Auvinen A, Stenman UH, et al.: Three-year results of the Finnish prostate cancer screening trial. [1] Thompson IM, Ankerst DP, Chi C, et al.: Assessing prostate cancer risk: results from the Prostate Cancer Prevention Trial. [1] Andriole GL, Guess HA, Epstein JI, et al.: Treatment with finasteride preserves usefulness of prostate-specific antigen in the detection of prostate cancer: results of a randomized, double-blind, placebo-controlled clinical trial. [1] Oliver SE, Barrass B, Gunnell DJ, et al.: Serum insulin-like growth factor-I is positively associated with serum prostate-specific antigen in middle-aged men without evidence of prostate cancer. [1] Platz EA, Leitzmann MF, Rimm EB, et al.: Alcohol intake, drinking patterns, and risk of prostate cancer in a large prospective cohort study. [1] Gann PH, Hennekens CH, Sacks FM, et al.: Prospective study of plasma fatty acids and risk of prostate cancer. [1] Chan JM, Stampfer MJ, Giovannucci E, et al.: Plasma insulin-like growth factor-I and prostate cancer risk: a prospective study. [1] Stattin P, Rinaldi S, Biessy C, et al.: High levels of circulating insulin-like growth factor-I increase prostate cancer risk: a prospective study in a population-based nonscreened cohort. [1] Beemsterboer PM, Kranse R, de Koning HJ, et al.: Changing role of 3 screening modalities in the European randomized study of screening for prostate cancer (Rotterdam). [1] Roobol MJ, Grenabo A, Schrer FH, et al.: Interval cancers in prostate cancer screening: comparing 2- and 4-year screening intervals in the European Randomized Study of Screening for Prostate Cancer, Gothenburg and Rotterdam. [1] Heijnsdijk EA, de Carvalho TM, Auvinen A, et al.: Cost-effectiveness of prostate cancer screening: a simulation study based on ERSPC data. [1]

781 men needed to be invited for screening to avert one prostate cancer death, and 48 men needed to be biopsied. [1] Do men with prostate cancer who take a statin drug to lower their cholesterol have reduced death rates? According to a new study. [29] Men with high-grade prostate cancers had an increased probability of dying from prostate cancer within 10 years of diagnosis (Gleason score of 8 to 10, 121 deaths per 1,000 person-years; 95% CI, 90-156). [1] The CISNET model assumes prostate cancer progression from onset to metastasis to clinical diagnosis in the absence of screening, with risks of events indicated by PSA levels. [1] These data lend credence to the concern that overdiagnosis of prostate cancer due to screening could lead to an increased risk of CVD mortality or suicide. [1] Simulation modeling from the NCI’s Cancer Intervention and Surveillance Modeling Network (CISNET) program suggested that the combination of changes in prostate cancer treatment, improvements in disease management after primary therapy, and screening contributed to the drop in prostate cancer mortality. [1] Screening tests are able to detect prostate cancer at an early stage, but it is not clear whether this earlier detection and consequent earlier treatment leads to any change in the natural history and outcome of the disease. [1] Rigorous evaluation of any prostate cancer screening modality is desirable because the natural history of the disease is variable, and appropriate treatment is not clearly defined. [1]

It has been reported that 25% of men presenting with metastatic disease had a normal prostate examination. [1] Parekh, D.J., et al. “A multi-institutional prospective trial in the United States confirms that the 4Kscore accurately identifies men with high grade prostate cancer.” [3] Prostate biopsies in a small percentage of men will demonstrate prostatic intraepithelial neoplasia (PIN). [1] Men can prevent prostate problems by having regular medical checkups that include a prostate exam. [3]

Sharpe JR, Sadlowski RW, Finney RP, et al.: Urinary tract infection after transrectal needle biopsy of the prostate. [1] Be aware that when a prostate is biopsied for diagnosis and then subsequently removed with a radical prostatectomy, Gleason scores are the same between the biopsy and surgery specimens only 75% of the time. [27] The current standard of care for men suspected of prostate cancer is referral for a biopsy for definitive diagnosis. [4] 27% of all men undergoing biopsy were found to have prostate cancer. [1] In Finland, 15,685 men were screened and 14% of screened men had PSA levels of at least 3.0 ng/mL. All men with PSAs higher than 4.0 ng/mL were recommended for diagnostic follow-up by DRE, ultrasound, and biopsy; 92% complied, and 2.6% of the 15,685 men screened were diagnosed with prostate cancer. [1]

The information contained in the report depends on whether the specimen is submitted from a biopsy (in which case “cores” of prostate tissue are received) or from a prostatectomy, which will include the entire prostate gland, seminal vesicles, vas deferens and lymph node(s). [27] Of 43 patients with a palpable abnormality in the prostate, 38 agreed to undergo biopsy. [1] In rare cases, they may perform a transurethral biopsy, in which a lighted lens is inserted through the urethra and samples are taken with a microscopic loop; or a transperineal biopsy, in which an incision is made to the perineal and tissue is taken from the prostate. [30] A biopsy is a surgery to get small pieces of the prostate to look at under a microscope. [26] You will probably never meet the pathologist, but samples of your prostate tissue that are removed during surgery or biopsy will be sent to the pathologist for review. [27] The most commonly used method is the transrectal biopsy, which uses a small ultrasound probe inserted in the rectum to guide the biopsy needles through the rectal tissue into the prostate. [27] The second method is the transperineal biopsy, which is performed by inserting needles through the perineum (the skin between the scrotum and rectum) into the prostate tissue. [27] The specimens submitted with a biopsy are referred to as “cores”, which are cylindrically shaped pieces of prostate tissue removed by the needles. [27]

Sakr WA, Haas GP, Cassin BF, et al.: The frequency of carcinoma and intraepithelial neoplasia of the prostate in young male patients. [1] Evidence from a nested case-control study within the Physicians? Health Study, in addition to a case-control study and a retrospective review of screened prostate cancer patients, suggests that higher plasma insulin -like growth factor-I levels may be associated with a higher prostate cancer risk. [1] Over the period of the study, 30 men (2%) in the invited group died of prostate cancer, compared with 130 (1.7%) men in the not-invited group. [1] The design called for 209,000 men in each group to provide sufficient events to allow a prostate cancer mortality RR of 0.87 to be detected with 80% power at a significance level of 0.05, assuming an uptake of PSA testing between 35% and 50%. [1] Another study adopted a change in the PSA cutoff to a level of 3.0 ng/mL to study the impact of this change in 243 men with PSA levels between 3.0 ng/mL and 4.0 ng/mL. Thirty-two of the men (13.2%) were ultimately found to have prostate cancer. [1] The study, published online Feb. 22, 2018, by JAMA Oncology included 651 men screened for prostate cancer with blood tests and digital rectal exams. [31] In the population-based Prostate Cancer Outcomes Study, 8.4% of 1,291 men were incontinent and 59.9% were impotent at 18 or 24 months following radical prostatectomy. [1] Men with prostate cancer have four main options for treatment: active surveillance, radical prostatectomy, external beam radiation therapy, and brachytherapy. [29] Active surveillance offers men who have a prostate cancer that is unlikely to cause harm without treatment the option of careful monitoring with the intention to treat for cure should the disease change over time. [29] Is prostate cancer the most common cancer in men? Take this quiz to find out and learn the causes, symptoms and treatments of this disease. [3]

Stamey TA, McNeal JE, Yemoto CM, et al.: Biological determinants of cancer progression in men with prostate cancer. [1] Bartsch G, Horninger W, Klocker H, et al.: Prostate cancer mortality after introduction of prostate-specific antigen mass screening in the Federal State of Tyrol, Austria. [1] Ross KS, Carter HB, Pearson JD, et al.: Comparative efficiency of prostate-specific antigen screening strategies for prostate cancer detection. [1] Catalona WJ, Smith DS, Ratliff TL, et al.: Detection of organ-confined prostate cancer is increased through prostate-specific antigen-based screening. [1] Etzioni R, Gulati R, Cooperberg MR, et al.: Limitations of basing screening policies on screening trials: The U.S. Preventive Services Task Force and Prostate Cancer Screening. [1] Volk RJ, Hawley ST, Kneuper S, et al.: Trials of decision aids for prostate cancer screening: a systematic review. [1] Taylor KL, Luta G, Miller AB, et al.: Long-term disease-specific functioning among prostate cancer survivors and noncancer controls in the prostate, lung, colorectal, and ovarian cancer screening trial. [1] Schrer FH, van der Maas P, Beemsterboer P, et al.: Evaluation of the digital rectal examination as a screening test for prostate cancer. [1] Possible harms included overdiagnosis, which was estimated at 30% on the basis of excess cases in the screening arm if the cumulative risk of prostate cancer had been the same as the control arm. [1] There was some evidence that the treatment administered to the prostate cancer cases differed by stage and by randomly assigned group, with the screening group more often receiving radical prostatectomy (40.3%) than the control group (30.3%). [1] Based on solid evidence, screening with PSA and/or DRE results in overdiagnosis of prostate cancers, and detection of some prostate cancers that would never have caused significant clinical problems. [1] The 4Kscore test combines the test results of four different proteins (prostate-specific kallikreins) in the blood together with clinical information in an algorithm that calculates an individual patient’s percentage risk of having an aggressive form of prostate cancer. [3] Steinberg GD, Carter BS, Beaty TH, et al.: Family history and the risk of prostate cancer. [1] Hayes RB, Brown LM, Schoenberg JB, et al.: Alcohol use and prostate cancer risk in U.S. blacks and whites. [1]

Radiation to the prostate has been reported to increase the risk of secondary malignancies, most notably of the rectum and bladder. [1] If you are concerned that you may have a greater risk for prostate cancer, talk to your doctor about screening. [26] Farkas A, Schneider D, Perrotti M, et al.: National trends in the epidemiology of prostate cancer, 1973 to 1994: evidence for the effectiveness of prostate-specific antigen screening. [1] Edlefsen KL, Mandelson MT, McIntosh MW, et al.: Prostate-specific antigen for prostate cancer screening. [1] The evidence is insufficient to determine whether screening for prostate cancer with prostate-specific antigen (PSA) or digital rectal exam (DRE) reduces mortality from prostate cancer. [1] Changes in prostate cancer mortality could not be explained entirely by PSA screening alone. [1]

After a median follow-up of 10 years (maximum up to about 15 years), there was no statistically significant difference in overall or prostate-specific mortality. (Refer to the Treatment Option Overview section in the PDQ summary on Prostate Cancer Treatment for a more detailed description of the study and results.) [1] After 7 to 10 years of follow-up, the rate of death from prostate cancer was very low and did not differ significantly between the two study groups. [1] An extended follow-up analysis for mortality, with median follow-up of almost 15 years ( intervention group, 14.8 years; usual-care group, 14.7 years), showed prostate cancer mortality rates of 47.8 (255 deaths) per 100,000 person-years in the intervention group and 46.0 (244 deaths) per 100,000 person-years in the usual-care group, given a rate ratio of 1.04 (95% CI, 0.87-1.24). [1]

In Olmsted County, Minnesota, age-adjusted prostate cancer mortality rates increased from 25.8 per 100,000 men from 1980 to 1984 to a peak of 34 per 100,000 from 1989 to 1992; rates subsequently decreased to 19.4 per 100,000 from 1993 to 1997. [1] A randomized trial in Scandinavian men published in 2002 explored the benefit of radical prostatectomy over watchful waiting in men with newly diagnosed, well-differentiated, or moderately well-differentiated prostate cancers of clinical stages T1b, T1c, or T2. [1] An analysis using the Microsimulation Screening Analysis (MISCAN) model and data from the ERSPC trial predicted the numbers of prostate cancers diagnosed, the prostate cancer deaths averted, the quality-adjusted life years (QALYs) gained, and the cost-effectiveness of 68 screening strategies. [1] The effectiveness of AS was investigated retrospectively in the European Randomized Study of Screening for Prostate Cancer (ERSPC) trial. [1] The Norrkoping study is a population-based nonrandomized trial of prostate cancer screening. [1] One case-control study reported no statistically significant association between routine screening with DRE and occurrence of metastatic prostate cancer. [1] In a study of Medicare beneficiaries, a first-time PSA test was associated with a 4.7% likelihood of a prostate cancer diagnosis within 3 months. [1] Turkes A, Peeling WB, Griffiths K: Serum IGF-1 determination in relation to prostate cancer screening: possible differential diagnosis in relation to PSA assays. [1]

There is evidence that not all patients diagnosed with prostate cancer as a consequence of screening are in immediate need of curative treatment. [1] The question of whether prostate cancer treatment contributes to symptoms among screened prostate cancer survivors was addressed in an analysis from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. [1] Active monitoring in this study, unlike the PIVOT and Scandinavian Prostate Cancer Group Trial 4 (SPCG-4) trials, used PSA levels to determine when more aggressive treatment would be administered. [1] Hot flashes occur in 50% to 60% of men taking LHRH agonists. (Refer to the PDQ summary on Prostate Cancer Treatment for more information.) [1] Some men may have a faster growing prostate cancer and will benefit from early treatment. [26] From November 1994 through January 2002, 731 men aged 75 years or younger with localized prostate cancer were randomly assigned to one of the two management strategies. [1] In the first 3 months after diagnosis, the SMR for suicide was higher in men with prostate cancer (SMR, 1.9; 95% CI, 1.4-2.6). [1] There were 214 prostate- cancer deaths in the screening group and 326 prostate cancer deaths in the control group in the core age group (RR, 0.80; 95% CI, 0.67-0.95). [1] At a median follow-up of 9 years, there were 5,990 prostate cancers diagnosed in the screening group (a cumulative incidence of 8.2%) and 4,307 prostate cancers in the control group (a cumulative incidence of 4.8%). [1] This nonstatistically significant finding provides no evidence that screening leads to a reduction in prostate cancer mortality, even after 20 years of follow-up. [1] Chou R, Croswell JM, Dana T, et al.: Screening for prostate cancer: a review of the evidence for the U.S. Preventive Services Task Force. [1] Stanford JL, Feng Z, Hamilton AS, et al.: Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: the Prostate Cancer Outcomes Study. [1] Chen C, Lewis SK, Voigt L, et al.: Prostate carcinoma incidence in relation to prediagnostic circulating levels of insulin-like growth factor I, insulin-like growth factor binding protein 3, and insulin. [1] Prostate specific antigen (PSA) is a protein that is found in the semen. [3] Feuer EJ, Mariotto A, Merrill R: Modeling the impact of the decline in distant stage disease on prostate carcinoma mortality rates. [1] Etzioni R, Gulati R, Tsodikov A, et al.: The prostate cancer conundrum revisited: treatment changes and prostate cancer mortality declines. [1] Dr. Evan Pisick discusses prostate cancer risk factors, symptoms, diagnosis and treatments. [28] The estimated lifetime risk of a prostate cancer diagnosis is about 14.0%, and the lifetime risk of dying from this disease is 2.6%. [1] The 10-year cumulative risk of death from prostate cancer for the entire 6,849 person cohort was 3.6% in the surveillance group and 2.7% in the curative-intent group compared with the low-risk surveillance group (2.4%) and the low-risk curative-intent group (0.7%). [1] There were 4,250 men diagnosed with prostate cancer in the intervention group and 3,815 men in the usual care group. [1] Many series have noted that PSA levels increase with age, such that men without prostate cancer will have higher PSA values as they grow older. [1] The American Cancer Society recommends that men make an informed decision with their doctor about whether to be tested for prostate cancer, beginning at age 50. [28] They observed that there were 4 prostate cancer deaths (0.056%) among the 7,155 men who were screened and 44 prostate cancer deaths (0.31%) among the 14,255 men who were not screened, an RR of 5.5. [1] Prostate cancer is now the second leading cause of cancer death in men, exceeded by lung cancer. [1] To extend one life, 20 men with palpable, clinically localized prostate cancer would need to undergo radical prostatectomy rather than watchful waiting. [1]

Only a biopsy can determine for certain whether prostate cancer is present, but a new study suggests that using magnetic resonance imaging (MRI) can help to better identify patients who are more likely to need a biopsy versus those who aren’t. [31] In about 20% of the cases, the surgery specimen actually ends up having a higher Gleason score (and thus a more aggressive cancer) than what was previously found on the initial biopsy. [27] If the biopsy shows there are cancer cells, then your doctor will discuss treatment options. [26] The only way to know if an abnormal test is due to cancer is to do a biopsy. [26] The remainder will have either a negative biopsy or a cancer with a score of Gleason 6, which currently is often managed with active surveillance. [3] The 4Kscore test helps clarify the biopsy decision-making process by determining a patient-specific probability for finding aggressive, Gleason score 7 or higher prostate cancer upon biopsy. [3] The goals of the biomarker tests are to decrease the risk of unnecessary biopsies and increase the likelihood of cancer detection without missing a significant number of prostate cancers. [3] Brawer MK, Meyer GE, Letran JL, et al.: Measurement of complexed PSA improves specificity for early detection of prostate cancer. [1] Legler JM, Feuer EJ, Potosky AL, et al.: The role of prostate-specific antigen (PSA) testing patterns in the recent prostate cancer incidence decline in the United States. [1] Etzioni R, Legler JM, Feuer EJ, et al.: Cancer surveillance series: interpreting trends in prostate cancer–part III: Quantifying the link between population prostate-specific antigen testing and recent declines in prostate cancer mortality. [1]

Note: Separate PDQ summaries on Prostate Cancer Prevention, Prostate Cancer Treatment, and Levels of Evidence for Cancer Screening and Prevention Studies are also available. [1] Rotterdam section of the European Randomized Study of Screening for Prostate Cancer. [1] Using a derived measure called mean lead-time (MLT), the investigators found substantial (likely inflated) reductions in prostate cancer mortality caused by screening. [1] Observational evidence shows a trend toward lower mortality for prostate cancer in some countries, but the relationship between these trends and intensity of screening is not clear, and associations with screening patterns are inconsistent. [1] The possible contribution of routine annual screening by rectal examination in reducing prostate cancer mortality remains to be determined. [1]

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