Florida Prostate Cancer Advisory Council (PCAC)
- Despite some of the possible short comings of the utilization of PSA in the detection of prostate cancer, it is the general consensus of the PCAC members that PSA has been a positive and major development in the detection and management of early prostate cancer. Many prostate cancer experts believe the utilization of PSA in early detection of prostate cancer was a major factor in the decline of prostate cancer deaths in the United States over the past twenty plus years. Finally, in comparison to many cancer detection tests, PSA is a relatively inexpensive, widely available and low risk blood test for the patient. PCAC feels that the patient and their healthcare provider should have a discussion regarding the positive and negative aspects of the PSA blood test for detection of prostate cancer.
- All Floridian men 40 years or older should be directed by their health care professional to the PCAC website to review information regarding prostate cancer, the controversies surrounding screening and the risks and benefits of early detection.
- All Floridian men 50 years of age at average-risk for prostate cancer should be encouraged to undergo early detection testing after being provided with thorough information on the burden of the disease, the potential for better detection with newer tests that may decrease the rate of unnecessary biopsies and potentially better predict aggressive cancer. Men with limited life expectancy (less than 5-10 years) should be discouraged from routine prostate cancer screening.
- All Floridian African-American men and men with first and second degree relatives with prostate cancer 40 years or older who are at higher risk of prostate cancer should be encouraged to undergo early detection testing.
- Early detection testing should include a PSA blood test, and consideration for supplemental PSA testing (4K or PHI) as indicated along with a digital rectal exam by their health care professional.
- All Floridian men undergoing early detection evaluation should be directed to the National Comprehensive Cancer Network (NCCN) website, www.nccn.org to follow up-to-date recommendations on early detection based on initial evaluation findings.
Risks of PSA Screening
- High negative biopsy rate in men with PSA levels between 4 and 10 ng/ml.
- Hematuria (blood in urine), hematospermia (blood in semen) or rectal bleeding
- Urinary retention (inability to urinate).
- 5% risk of infection overall and up to 7.5 risk of infection in African Americans. Hospitalization risk 1-2%.
- Detecting non-life-threatening cancers and subjecting these men to unnecessary treatments with their associated risks and complications.
Benefits of PSA Screening
- Detecting early, life threatening cancers that may be cured with definitive treatment.
How do we decrease the number of unnecessary biopsies and improve detection of life-threatening cancers?
- Age adjusted PSA
- PSA velocity
- PSA density
- % free PSA
- Prostate Health Index (PHI)
- Multiparametric prostate MRI
- Risk calculator for prediction low vs high-risk prostate cancer
The controversies and science regarding early detection and screening of prostate cancer are continuing to evolve. PCAC’s recommendations represent the current consensuses of published scientific data, suggested prostate screening guidelines, and the opinions of the PCAC members. We encourage those who are interested in prostate cancer detection and screening to review the web sites we have listed. Our suggestions and the recommendations of others should help individual men make an informed decision on whether to proceed with prostate cancer screening. In addition, it is suggested that the patient should consult his primary care physician and/ or urologist to discuss prostate cancer screening issues.
Early Detection for Prostate Cancer
Florida Prostate Cancer Advisory Council (PCAC)
- Regarding Prostate Cancer
- Prostate cancer becomes increasingly common with age, especially after age 50.
- Some cancers are called “clinically insignificant” meaning that they are not going to affect a man’s health or life expectancy.
- Some cancers may be progressive and lethal.
- There is not at present a test that can tell in the screening setting if a man has a clinically insignificant vs a lethal cancer.
- Regarding Screening Tests
- There is no screening test to tell clinically insignificant from life-threatening prostate cancers.
- Close to 40% of men diagnosed with prostate cancer with an elevated PSA have slowly progressive non-lethal prostate cancers, this is called OVERDIAGNOSIS.
- A PSA blood test is readily available and can easily be obtained through a simple uncomplicated blood test from the patient’s arm vein. While PSA screenings may help detect prostate cancer, it is not a highly sensitive or specific test.
- 65% – 70% of men who undergo a biopsy because of an elevated PSA may have a negative biopsy. In some cases, more than one biopsy session may be needed to rule out the diagnosis of prostate cancer.
- Many men undergo treatment of their non-lethal cancer, this is called OVERTREATMENT.
- Large population-based studies have addressed benefits and risks to prostate cancer screening. A European study showed a reduction in mortality and metastatic disease at diagnosis but with a large screening burden that reduced over time. A U.S. study looking at screened and unscreened populations showed no difference in prostate cancer mortality. However, the U.S. study was found to have significantly flawed methodology.
- This benefit was greater if men were screened between 55 to 65 years of age.
USPSTF recommendations on screening
- Because of these findings, in 2012, the United States Preventive Task Force (USPSTF) advised against screening for prostate cancer with assignment of a Grade D recommendation. Moderate to high certainty that the service has no net benefit or that the harms outweigh the benefits.
- In 2018, the European Randomized Study of Screening for Prostate Cancer (ESPRC) determined the number needed to screen to prevent one prostate cancer death reduced from 1400 at 9 years to 570 at 16 years on longitudinal analysis of the study cohort . Additionally, the risk of metastasis reduced 30% in the screened group. Therefore, in response to the longitudinal data analysis out to 13 years, the USPSTF recommended a screening adjustment to Grade C for a limited population of men. The recommendation was for discussion of risk and benefits to screening in the 55-69 year old age group and individual decision-making. No risk adjustment was made for African Americans, males with significant family history of prostate cancer or for older healthy males.
Associations and Organizations
AUA (American Urological Association)
NCCN (National Comprehensive Cancer Network)
ACS (American Cancer Society)
ACP (American College of Physicians) Recommendations On Screening
- Close to 30,000 men die every year from prostate cancer making it the most common cause of cancer death in US men.
- Additionally, men with aggressive cancer could live years with serious side effects resulting from prostate cancer. Spread of prostate cancer (metastasis) can severely decrease the longevity of the patient as well as the quality of life of the patient and his family.
- Because of these observations, they recommend that men are given information regarding the risks vs benefits of screening and give men the chance to make an informed decision on whether they want to proceed with screening.
PCAC (Florida Prostate Cancer Advisory Council) Guidelines
- Due to the significant controversies with screening for prostate cancer and evidence that, when appropriately used, judicious PSA testing may benefit men who harbor clinically significant prostate cancer, PCAC recommends that health care professionals direct men to the education resources available at the PCAC website where information may be found regarding the benefits and risk of screening and for health care providers to encourage men to undergo early detection testing as defined in the guideline statement.
- There are newer tests that are making early detection of significant cancers more accurate. These new tests address the concern of OVERDIAGNOSIS.
- There is evolving knowledge and testing to define clinically insignificant cancers. Men with these cancers may be managed by active surveillance. This knowledge is leading to a continuous decrease of OVERTREATMENT of non-lethal prostate cancer.
- The 2018 USPSTF recommendations for shared decision making for PSA screening in the 55-69 year-old age group more closely align with the American Urological Association (AUA) and most major physician group recommendations.
- Although a positive step, PCAC and the AUA feel that the current USPSTF recommendations fall short of addressing risk factors for early onset disease prior to age 55 or disease impactful to healthy age 70 or older men with a greater than 10 year life expectancy. Known risk factors that need to be part of an informed conversation for screening with all men as early as age 40-45 include race, family history and chemical exposure including Agent Orange.
- PCAC applauds the effort of the USPSTF to address PSA based screening recommendations in populations of men at risk for prostate cancer. The expanded effort has included review of relevant updated data and inclusion of pertinent expert opinion within the field. Application of individual risk factors for detection of aggressive disease in younger and older men will need to be the next evolution of universal guidelines for prostate cancer screening.
Screening for prostate cancer is controversial. While the United States Preventive Services Task Force (USPSTF) recommends against screening, other organizations including the American Urological Association (AUA), American Cancer Society (ACS), National Comprehensive Cancer Network (NCCN) and American College of Physicians (ACP), recommend informing men of the risks and benefits of early detection. There are men at higher risk (African-Americans and men with a family history of first or second degree relatives with prostate cancer) of developing prostate cancer. Importantly, African- American men have a higher risk of mortality from prostate cancer.
Current US Guidelines
- United States Preventive Services Task Force (USPSTF) | Revised 2018 | Current US Guidelines.
2018 USPSTF Recommendation Summary
For men aged 55 to 69 years, the decision to undergo periodic prostate-specific antigen (PSA)-based screening for prostate cancer should be an individual one. Before deciding whether to be screened, men should have an opportunity to discuss the potential benefits and harms of screening with their clinician and to incorporate their values and preferences in the decision. Grade C
The USPSTF recommends against PSA-based screening for prostate cancer in men 70 years and older. Grade D
American Urological Association (AUA)
Guideline Statements Reviewed and updated 2018
Guideline Statement 1: The Panel recommends against PSA screening in men under age 40 years. (Recommendation; Evidence Strength Grade C)
- In this age group there is a low prevalence of clinically detectable prostate cancer, no evidence demonstrating benefit of screening and likely the same harms of screening as in other age groups.
Guideline Statement 2: The Panel does not recommend routine screening in men between ages 40 to 54 years at average risk. (Recommendation; Evidence Strength Grade C)
- For men younger than age 55 years at higher risk, decisions regarding prostate cancer screening should be individualized. Those at higher risk may include men of African American race; and those with a family history of metastatic or lethal adenocarcinomas (e.g., prostate, male and female breast cancer, ovarian, pancreatic) spanning multiple generations, affecting multiple first-degree relatives, and that developed at younger ages.
Guideline Statement 3: For men ages 55 to 69 years the Panel recognizes that the decision to undergo PSA screening involves weighing the benefits of reducing the rate of metastatic prostate cancer and prevention of prostate cancer death against the known potential harms associated with screening and treatment. For this reason, the Panel strongly recommends shared decision-making for men age 55 to 69 years that are considering PSA screening, and proceeding based on a man’s values and preferences. (Standard; Evidence Strength Grade B)
- The greatest benefit of screening appears to be in men ages 55 to 69 years.
- Multiple approaches subsequent to a PSA test (e.g., urinary and serum biomarkers, imaging, risk calculators) are available for identifying men more likely to harbor a prostate cancer and/or one with an aggressive phenotype. The use of such tools can be considered in men with a suspicious PSA level to inform prostate biopsy decisions.
Guideline Statement 4: To reduce the harms of screening, a routine screening interval of two years or more may be preferred over annual screening in those men who have participated in shared decision-making and decided on screening. As compared to annual screening, it is expected that screening intervals of two years preserve the majority of the benefits and reduce overdiagnosis and false positives. (Option; Evidence Strength Grade C)
- Additionally, intervals for rescreening can be individualized by a baseline PSA level.
Guideline Statement 5: The Panel does not recommend routine PSA screening in men age 70+ years or any man with less than a 10 to 15 year life expectancy. (Recommendation; Evidence Strength Grade C)
- Some men age 70+ years who are in excellent health may benefit from prostate cancer screening.
American Cancer Society (ACS)
The American Cancer Society (ACS) recommends that men have a chance to make an informed decision with their health care provider about whether to be screened for prostate cancer. The decision should be made after getting information about the uncertainties, risks, and potential benefits of prostate cancer screening. Men should not be screened unless they have received this information. The discussion about screening should take place at:
- Age 50 for men who are at average risk of prostate cancer and are expected to live at least 10 more years.
- Age 45 for men at high risk of developing prostate cancer. This includes African Americans and men who have a first-degree relative (father, brother, or son) diagnosed with prostate cancer at an early age (younger than age 65).
- Age 40 for men at even higher risk (those with more than one first-degree relative who had prostate cancer at an early age).
After this discussion, those men who want to be screened should be tested with the prostate-specific antigen (PSA) blood test. The digital rectal exam (DRE) may also be done as a part of screening. If, after this discussion, a man is unable to decide if testing is right for him, the screening decision can be made by the health care provider, who should take into account the patient’s general health preferences and values.
Assuming no prostate cancer is found as a result of screening, the time between future screenings depends on the results of the PSA blood test:
- Men who choose to be tested who have a PSA of less than 2.5 ng/mL may only need to be retested every 2 years.
- Screening should be done yearly for men whose PSA level is 2.5 ng/mL or higher.Even after a decision about testing has been made, the discussion about the pros and cons of testing should be repeated as new information about the benefits and risks of testing becomes available. Further discussions are also needed to take into account changes in the patient’s health, values, and preferences.
Because prostate cancer often grows slowly, men without symptoms of prostate cancer who do not have a 10-year life expectancy should not be offered testing since they are not likely to benefit. Overall health status, and not age alone, is important when making decisions about screening.
Even after a decision about testing has been made, the discussion about the pros and cons of testing should be repeated as new information about the benefits and risks of testing becomes available. Further discussions are also needed to take into account changes in the patient’s health, values, and preferences
National Comprehensive Cancer Network (NCCN)
- NCCN Guidelines Version 2.2015 – Prostate Cancer Early Detection
- NCCN Guidelines Version 2.2015 – Prostate Cancer Early Detection Part 2
American College of Physicians (ACP)
Screening for Prostate Cancer: A Guidance Statement From the Clinical Guidelines Committee of the American College of Physicians
Ann Intern Med. 2013;158(10):I-28. doi:10.7326/0003-4819-158-10-201305210-00634
Who developed these recommendations?
The Clinical Guidelines Committee of the American College of Physicians (ACP) developed these guidelines. ACP is a professional organization for internal medicine doctors, who are specialists in adult care.
What is the problem and what is known about it so far?
Prostate cancer is the most commonly diagnosed nonskin cancer among men in the United States. The most common prostate cancer symptoms are difficult or frequent urination, but many men have no symptoms.
A blood test that measures prostate-specific antigen (PSA) levels can find prostate cancer before symptoms develop. If the PSA level is high, a prostate biopsy may be needed to see whether cancer is actually present. A biopsy is a procedure that is done to obtain a piece of the prostate for examination.
Most prostate cancer grows slowly, and many men with prostate cancer die of something other than prostate cancer. Currently, there is no way to know which cases of prostate cancer are life-threatening and require treatment and which cases are not. When screening identifies cancer that is not life-threatening, men experience unnecessary worry and complications from treatment. Common complications include urinary incontinence and erectile dysfunction.
Organizations have guidelines for prostate cancer screening that provide different and conflicting advice. ACP evaluated available guidelines to help doctors and patients make better decisions.
How did the ACP develop these recommendations?
The National Guideline Clearinghouse (NGC) is a database developed by the U.S. government to make clinical guidelines widely available. The authors searched the database for U.S. guidelines about prostate cancer screening with PSA. They evaluated each guideline using a published instrument that considers 23 standard criteria for the quality of guidelines and rated each guideline from 1 (worst) to 7 (best).
What did the authors find?
The authors found 4 guidelines: American College of Preventive Medicine, 2008 (rating of 3); American Cancer Society, 2010 (rating of 5); American Urological Association, 2009 (rating of 3); and the U.S. Preventive Services Task Force, 2012 (rating of 6).
They conclude that PSA is not just a blood test. It can open the door to more testing and treatment that a man may not want or that may harm him. Because chances of being harmed are greater than chances of benefiting, each man should have the opportunity to decide for himself whether to be screened.
What does the ACP recommend that patients and doctors do?
Doctors should inform men aged 50 to 69 years about the limited potential benefits and substantial potential harms of prostate cancer screening. Patients and doctors should base screening decisions on the patient’s preferences, prostate cancer risk, health, and life expectancy.
Doctors should not screen for prostate cancer using PSA unless patients express a clear preference for screening after discussion.
Doctors should not screen using PSA in average-risk men younger than 50 years or older than 69 years, or any man with a life expectancy less than 10 to 15 years.
What are the cautions related to these recommendations?
These recommendations apply to men at average risk for prostate cancer who do not have symptoms that could be caused by prostate cancer. The authors did not consider non-U.S. guidelines.
Ad Hoc Committee
- Julio Pow-Sang, MD, Moffitt Cancer Center
- Neal P. Dunn, MD, FACS, Urologist
- Mr. Charles Griggs, 100 Black Men of Jacksonville
- Ali Kasraeian, MD, Urologist
- Alan Pollack, MD, University of Miami
- Tom Stringer, MD, University of Florida
- Mike Wehle, MD, Urologist
Phone: (352) 273-8236