Tag Archives: Prostate Cancer

Racial Differences in Prostate Cancer

Prostate Cancer, Prostate Cancer, , , ,

Meg Seymour, PhD: National Center for Health Research

About 13% of men will develop prostate cancer during their lifetime, and about 2-3% of men will die from it.[1] After lung cancer, prostate cancer is the leading cause of cancer deaths in men[2], and older men are more likely to get prostate cancer then younger men.[1]

There are known racial differences as well: Black men are 1.5 times more likely to get prostate cancer than White or Latino men, and 3 times more likely to get prostate cancer than Asians and Pacific Islanders.[3,4] On average, Black men get prostate cancer a younger ages than other men, and their cancer is often more aggressive and more advanced when it is discovered.[1] Black men are also more than twice as likely to die from prostate cancer than men from other races.[1] 

This article will discuss the known racial differences in the screening, treatment, and outcomes of prostate cancer in the United States, as well as why these differences may exist. Note that many of the differences that have been studied compare Black and White men, and data about men from other races and ethnicities are more limited.

Differences in Screening

One of the main methods of screening for prostate cancer is a blood test that measures levels of prostate-specific antigen (PSA). PSA tests alone cannot tell if someone has cancer, but high levels of PSA might lead to further testing, like a biopsy. Another method of testing is the digital rectal exam, in which a doctor inserts a (gloved and lubricated) finger into a patient’s rectum to feel the prostate for bumps or hard areas, which might be cancer. 

As of 2018, the United States Preventive Services Task Force does not recommend prostate cancer screening for men ages 70 and over.[5] For men ages 55 to 69, they recommend that PSA screening should be an individual choice, based on factors such as family history or patient preference. For more information about prostate cancer screening and the recommendations for it, you can read this article.

If the results of a PSA test or digital rectal exam leads a doctor to suspect cancer, it can lead to a biopsy. A biopsy is when a small sample of tissue is removed and examined under a microscope for cancer cells.[6]

A 2017 article in a medical journal found that overall, non-Hispanic White men were slightly more likely to undergo PSA screening than Black men. This was a trend for the United States overall, but analysis by individual states showed that screening rates were actually higher for Black men in some states.[7] More recently, a 2020 study showed that between 2014 and 2018, Black men underwent prostate cancer screening at either a slightly lower rate than White men or at the same rate.[8] The study authors note that Black men need to be more intensively screened because they are more likely to get prostate cancer.  

A study presented at the 2021 meeting of the American Society of Clinical Oncology included over 4,000 Black men ages 40-55 who had been diagnosed with prostate cancer.[9] The study found that men who had an average of 3 PSA tests prior to their diagnosis were less likely to have metastatic disease than men who had an average of 0.5 PSA tests at the time of their diagnosis. Only 1.4% of the men who had been screened an average of 3 times had metastatic disease, compared with 4.2% of the men who had the least screening. Higher rates of PSA screening prior to diagnosis was also associated with a 25% reduction in the risk of dying from prostate cancer. The study suggests that more frequent PSA screening is associated with better outcomes among younger Black men.

Accuracy of screening also varied by race. A 2018 study found that although Black men were slightly more likely to have a false positive from their PSA screening, they were less likely to have a false positive from a digital rectal exam. Further, Black men were more likely than White men to have aggressive tumors and cancer that has metastasized, which means that it has spread to other body parts.[10] 

Differences in Treatment

There are numerous treatment options for prostate cancer, such as surgery, radiation, hormone therapy, and what are called watchful waiting and active surveillance. These treatment choices also vary by race.  

Active surveillance means that no specific treatment like surgery or a drug is used. Instead, a doctor closely monitors the cancer to see if it grows, using regular PSA tests, digital rectal exams, and biopsies. This option may be used if a man’s cancer is small, localized, or expected to grow slowly, so that he is not immediately treated with aggressive treatments that may have side effects.[11] Active surveillance is used for as many as 33% of men diagnosed with prostate cancer,[12] but it is not equally used among all men in the United States. A 2020 study found that although Black and White men receive active monitoring at the same rate, Hispanic men were less likely to receive it.[12] The researchers could not identify why this ethnic difference exists, but they noted that it could have to do with factors such as patient preferences or how often the option is offered by doctors.

Watchful waiting (also called observation) is slightly different from active surveillance. It involves less intensive follow-up, such as fewer tests. Instead, the patient’s doctor decides to wait and see if symptoms change. For many men, prostate cancer grows so slowly that a man might die of other causes before he would die of the cancer, so aggressive treatment is not needed. Treatments for prostate cancer can cause undesired side effects, such as incontinence and impotence, so many men may choose active surveillance or watchful waiting, if their cancer is considered low-risk enough.  

Definitive therapy refers to radiation treatment or surgical removal of the prostate. Both procedures can have side effects such as erectile dysfunction and impotence.[13] A 2017 study looked at over 300,000 men who were diagnosed with localized prostate cancer and compared which men received definitive treatments, such as surgery, to which men received no treatment, such as men undergoing active surveillance. The study found that although White and Asian men received definitive treatment at about the same rate, Hispanic and Black men were less likely to receive it than White men were.[14] In the study, Black men with high risk prostate cancer were actually less likely to receive definitive therapy than White men with lower risk disease. Although Black men were likely to be on active surveillance, Black men on active surveillance are actually monitored less than White men on active surveillance. The researchers argue that Black men might be more likely than White men to benefit from definitive therapy, so they are concerned by the result that they are less likely to receive it. 

A 2016 study looked at surgical treatments for localized prostate cancer in men insured by Medicare. The researchers found that, on average, Black patients experienced a longer delay between diagnosis and treatment, and had more postoperative complications than White patients.[15] Research on men with metastatic prostate cancer has also found that Black men treated with the drugs docetaxel, abiraterone acetate, or enzalutamide have similar or even better outcomes to other men.[16] Researchers question why Black men have overall higher mortality rates from prostate cancer than other men. For example, is the higher death rate among Black men because they often have more advanced cancer when it is discovered, because their cancer is more aggressive, or because there is unequal access to treatments?

Why Do These Differences Exist?

Some people have suggested that racial differences in prostate cancer outcomes are because White men are, on average, of higher socioeconomic status than Black men. However, research has found that comparing men of the same socioeconomic status level, cancer screening was still more common among White men and detection of cancer was also earlier for White men.[17]

Researchers have suggested that differences in survival by race may be because Black men are more likely to be diagnosed at advanced stages of their cancer, when treatment options are more limited and can be less effective.[17] They are also more likely to have comorbid illnesses, such as diabetes and hypertension, which could affect survival rates.

A 2016 study found that, among men with localized prostate cancer, when researchers adjust for differences like at what stage a man’s cancer was diagnosed and what treatment he received, survival rates are equal across all races of men.[15] It is possible that the differences in cancer survival between races are due to racial differences in access to care.

There is an ongoing need for research into the causes of racial disparities in prostate cancer outcomes. 

The Bottom Line

Prostate cancer is a common form of cancer in men, and although it does not always need to be actively treated, it is one of the leading cancer killers. Black men are disproportionately affected. They are often diagnosed at younger ages, with more advanced stages of cancer, with more aggressive cancers, and they may be more likely to need screening. Further research is needed to understand the causes in racial differences in prostate cancer, but at least some of the differences in rates of survival between Black and White men may be due to differences in access to medical care.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

The National Center for Health Research is a nonprofit, nonpartisan research, education and advocacy organization that analyzes and explains the latest medical research and speaks out on policies and programs. We do not accept funding from pharmaceutical companies or medical device manufacturers. Find out how you can support us here.

References 

  1.     Centers for Disease Control and Prevention. Who Is at Risk for Prostate Cancer?. Cdc.gov. https://www.cdc.gov/cancer/prostate/basic_info/risk_factors.htm. Updated August 2020. 
  2.     Siegel DA, O’Neil ME, Richards TB, Dowling NF, Weir HK. Prostate Cancer Incidence and Survival, by Stage and Race/Ethnicity — United States, 2001–2017. MMWR Morbidity and Mortality Weekly Report. 2020;69:1473–1480. 
  3.     Borno H, George DJ, Schnipper LE, Cavalli F, Cerny T, Gillessen S. All men are created equal: addressing disparities in prostate cancer care. American Society of Clinical Oncology Educational Book. 2019 May 17;39:302-8.
  4.     Dobbs RW, Malhotra NR, Abern MR, Moreira DM. Prostate cancer disparities in Hispanics by country of origin: a nationwide population-based analysis. Prostate Cancer and Prostatic Diseases. 2019 Mar;22(1):159-67.
  5.     Fenton JJ, Weyrich MS, Durbin S, Liu Y, Bang H, Melnikow J. Prostate-specific antigen–based screening for prostate cancer: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018 May 8;319(18):1914-31.
  6.     American Cancer Society. Tests to Diagnose and Stage Prostate Cancer. Cancer.org. https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/how-diagnosed.html. Updated December 2020. 
  7.     Jindal T, Kachroo N, Sammon J, Dalela D, Sood A, Vetterlein MW, Karabon P, Jeong W, Menon M, Trinh QD, Abdollah F. Racial differences in prostate-specific antigen–based prostate cancer screening: state-by-state and region-by-region analyses. Urologic Oncology: Seminars and Original Investigations. 2017; 35(7):460-e9. 
  8.     Kearns JT, Adeyemi O, Anderson WE, Hetherington TC, Taylor YJ, Zhu J, Burgess EF, Gaston KE. Contemporary racial disparities in PSA screening in a large, integrated health care system. 2020; 38(6): 308-308. 
  9.   Bassett M. Vaccination, Screening Succeeds in Cervical and Prostate Cancers. MedPageToday. https://www.medpagetoday.com/meetingcoverage/asco/92688. May 19, 2021. 
  10.     Miller EA, Pinsky PF, Black A, Andriole GL, Pierre‐Victor D. Secondary prostate cancer screening outcomes by race in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Screening Trial. The Prostate. 2018; 78(11):830-8.
  11. American Cancer Society. Observation or Active Surveillance for Prostate Cancer. Cancer.org. https://www.cancer.org/cancer/prostate-cancer/treating/watchful-waiting.html. Updated August 2019. 
  12. Washington SL, Jeong CW, Lonergan PE, Herlemann A, Gomez SL, Carroll PR, Cooperberg MR. Regional Variation in Active Surveillance for Low-Risk Prostate Cancer in the US. JAMA Network Open. 2020; 3(12):e2031349-.
  13. Tracy CR. Prostate Cancer Treatment & Management. Emedicine.medscape.com,. https://emedicine.medscape.com/article/1967731-treatment. Updated February 2, 2021. 
  14. Moses KA, Orom H, Brasel A, Gaddy J, Underwood III W. Racial/ethnic disparity in treatment for prostate cancer: does cancer severity matter?. Urology. 2017;99:76-83.
  15. Schmid M, Meyer CP, Reznor G, Choueiri TK, Hanske J, Sammon JD, Abdollah F, Chun FK, Kibel AS, Tucker-Seeley RD, Kantoff PW. Racial differences in the surgical care of Medicare beneficiaries with localized prostate cancer. JAMA Oncology. 2016;2(1):85-93.
  16. Hahn AW, Bilen MA, Agarwal N. Successful Recruitment of Black Men to Prostate Cancer Clinical Trials—A Lesson in Achievement. JAMA Network Open. 2021;4(1):e2034652-.)
  17. Di Pietro G, Chornokur G, Kumar NB, Davis C, Park JY. Racial differences in the diagnosis and treatment of prostate cancer. International Neurourology Journal. 2016;20(Suppl 2):S112.

NCHR’s Testimony to FDA on TOOKAD to Treat Low-Risk Prostate Cancer

Prostate Cancer, Testimony & Briefings, ,

Diana Zuckerman, National Center for Health Research, February 26, 2020

Thank you for the opportunity to speak today.  I am Dr. Diana Zuckerman, president of the National Center for Health Research. Our center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.

Although active surveillance is recommended for many patients with low-risk prostate cancer, some patients prefer treatment and that can be a reasonable choice as long as the treatment has a meaningful benefit and does not increase patients’ harms. However, the clinical data for TOOKAD that we are discussing today do not clearly demonstrate that its benefits outweigh its risks – efficacy is uncertain, particularly for U.S. patients, and the drug has the well-known very negative side effects typical of prostate cancer treatments.  

There are 5 major problems with the data, and the FDA did an excellent job of expressing their concerns:

#1.  There was only 1 clinical trial. Replication is the key to science, and effective treatments are available for prostate cancer, so the FDA should not approve a new treatment based on just one study.

#2.  This one trial took place in Europe, and 99.8% of participants were white.  Five patients – not 5% but only 5 men — were not white. Given the higher percentage of African American men who die of prostate cancer, this lack of diversity should not be considered acceptable, unless the FDA is considering approving this product for white men only.

#3. The accuracy of detecting cancer is one major problem. The data showed a high false negative rate. 13.5% of those in the active surveillance arm had a negative biopsy after 2 years. Since it is unlikely that the cancer would spontaneously disappear, this probably reflects false positives in the original diagnosis or false negatives in the post-test. This high false negative rate raises major concerns about the accuracy of biopsies in the treatment arm and at baseline. 

#4. Further, there was a large amount of missing data regarding biopsies at 24 months. Unfortunately, 18.4% of the patients in the treatment arm and 41.5% of those in the active surveillance arm were missing these crucial pieces of information regarding efficacy.  That makes it impossible to draw conclusions based on this one study. 

 #5. The trial was open-label, meaning patients as well as those collecting the data knew whether a particular patient was receiving the treatment or active surveillance. The decision to pursue definitive therapy  — such as surgery — was a subjective decision. Wouldn’t active surveillance patients be more likely to choose treatments later. Also, when biopsy results were uncertain, pathologists may have been biased by their knowledge of whether or not a patient was assigned to the treatment group. 

The FDA held a workshop in September 2018 to discuss issues related to clinical trials of novel treatments for localized prostate cancer.  They concluded that treatment endpoints might be clinically meaningful only if 1) the patients using the new therapy were less likely to undergo subsequent treatment (such as surgery), 2) there was an overall reduction in adverse events, and 3) there was no reduction in long-term cancer control.  However, in this trial, these criteria were not met. 95% of those treated with TOOKAD had adverse event in the weeks after treatment compared to 55% of the men on active surveillance. For many men these problems continued 2 years after treatment, when 34% continued to have urinary problems compared to 16% with active surveillance. Two years after treatment, 38% of patients treated with TOOKAD had erectile dysfunction, compared with 12% of those assigned to active surveillance. In other words, erectile dysfunction was 3x as prevalent among those treated with TOOKAD.

The long-term complications of the treatment that are unclear.  In addition to the urinary problems and ED that might be worse for those who are subsequently treated with surgery, it may be more difficult to obtain accurate biopsies. 

The American Urological Association recommends active surveillance as the best available treatment for low-risk prostate cancer patients, and the data clearly support that recommendation.  We understand that the fear of cancer can persuade men to seek treatment, but if so they should not be bamboozled by ads to choose a product that may have no benefits for them but that does have clear risks of erectile dysfunction and urinary problems. If the FDA thinks this product might have a useful benefit, they should require at least one double-blind study – preferably two – since the treatment does not involved surgery and is therefore easier to blind.  The studies should also include a patient population that represents the diversity of men with prostate cancer. There is no need to rush to approve this particular treatment based on a single, open label trial with endpoints of questionable clinical relevance and problems with inaccurate diagnoses. Better research needs to be completed before approval because the sponsor did not comply with FDA’s recommendations for the study and was even less likely to do so after the product is approved.   

The Oncologic Drugs Advisory Committee voted 13 to 2 against approval of TOOKAD to treat low-risk prostate cancer.

Are Annual Prostate Cancer Screenings Necessary? Should Early Stage Prostate Cancer Be Treated?

Prevention, Prostate Cancer, Prostate Cancer,
By Krystle Seu, Dana Casciotti, PhD, Brandel France de Bravo, MPH, Mingxin Chen, MHS, and Nicholas Jury, PhD

Although usually not fatal, prostate cancer is second leading cause of cancer deaths for men in the United States, after lung cancer.[1] One in every eight men will be diagnosed with prostate cancer in his lifetime.1 Most cases are in men 65 and older, and most deaths occur in men 75 and older.2 Annual screenings would seem to be an important way to prevent prostate cancer.  But there is a hot debate within the medical community: Do routine prostate cancer screenings lead to unnecessary treatment that does more harm than good?

Should I Get Screened?

Diagnostic tests for prostate cancer are recommended for any man who has symptoms of prostate cancer, such as pain or changes in urination. Men over the age of 50 who have no symptoms sometimes undergo screening tests. In May 2012, the U.S. Preventive Services Task Force recommended against prostate-specific antigen (PSA) screening tests for men of any age.3 However, in May 2018, the Task Force revised their recommendation, stating that men ages 55-69 years old should talk to their doctor about the potential benefits and harms of PSA screening. The USPSTF continues to recommend against PSA screening in men ages 70 and older.4

What about other methods of screening, like digital rectal exams, which are usually done together with PSA testing? The Task Force continues to conclude that they tend to do more harm than good.

The U.S. Preventive Services Task Force is an independent group of medical professionals that reviews all evidence on preventive health care services. In 2008, the Task Force had said screening was not recommended for men over 75, but wasn’t sure about its value for men younger than 75.5 In 2009, the American Urological Association issued new guidelines saying that annual screening was no longer recommended.6

The reason why these experts concluded that screening was rarely necessary is that prostate cancer grows very slowly.  Even without treatment, many men with prostate cancer will live with the disease until they eventually die of some other, unrelated cause.  However, there is concern that without screening, some men are being diagnosed with prostate cancer when it is more advanced and more likely to be fatal.  While annual screening seems unnecessary, this article will help you decide whether occasional screening is a good idea for you.

Types of Prostate Cancer Screening: PSA Blood Tests and Digital Rectal Exams

Prostate cancer occurs when cells create small tumors in the prostate gland, which is an important part of the male reproductive system. Screening can be performed quickly and easily in a physician’s office using two tests: the prostate-specific-antigen (PSA) blood test, and the digital rectal exam (DRE), a manual exam of the prostate area.

Most screening tests are not 100% accurate, but these prostate tests are especially inaccurate.  Most men with a high PSA level (>4ng/mL) do not have prostate cancer (this is known as a false positive), and some men with prostate cancer have a low PSA level (this is called a false negative). The DRE also results in many false positives and false negatives. Using both screening methods together will miss fewer cancers but also increases the number of false positives, which can lead to more testing (usually biopsies of the prostate) and possibly result in medical complications. A biopsy to determine if there is a cancerous growth in the prostate involves inserting a needle, usually through the rectum, to remove a small sample of prostate tissue.

PSA Velocity

Researchers are also trying to determine if other types of PSA testing might be more accurate in detecting prostate cancer, such as changes in PSA levels when a man has multiple tests over time. The rate of change of PSA level from one test to the next is known as “PSA velocity.”

One study examined if PSA velocity could improve cancer detection compared to standard PSA and DRE screening tests.7 Because men with high PSA levels and positive DRE results typically undergo prostate biopsies to determine the presence of cancer, this study evaluated if PSA velocity helped detect cancer in men with low PSA and negative DRE results. Over 5,500 men were included in the study and men with high PSA velocity-almost 1 in 7 men-were biopsied. The researchers found that doing biopsies on the basis of high PSA velocity in the absence of a high PSA or positive DRE would lead to a large number of biopsies but would not improve cancer detection.

What Recent Research Tells Us About Prostate Cancer Screening

Depending on how often screening is done, it may help reduce the chances of dying of prostate cancer, but the research indicates that the vast majority of men with prostate cancer die of a different cause, even if they are not treated.

Several years ago, two major research studies have tried to shed light on the value of regular screening: the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial and the European Randomized Trial of Screening for Prostate Cancer (ERSPC).8 The PLCO studied 76,000 men, aged 55-74, for 7-10 years and found that the death rate from prostate cancer was low, and that it did not differ between the men who were screened every year for the first six years of the study and those who received their usual care (which ranged from no screening to occasional screening).9 For most of the patients, “usual care” included at least one screening during the first seven years of the study. There were also no significant differences in overall death rates between the groups. Although the randomized portion of the study was completed in 2006, researchers are still studying the patients to see how long they live.10

The European study (ERSPC) included 182,000 men, ranging from 50 to 74 years old, from seven different European countries.11 In these countries, “regular screening” is usually every 4 years, although it is every 2 years in Sweden. Those men were compared to men of the same age who did not get any prostate cancer screening. After the men were studied for an average of 13 years, the researchers found that the patients who had PSA screening were 27% less likely to die of prostate cancer.8 However, they did not live longer than the other men, because they died of other causes.

A follow-up to the ERSPC study, which tracked the men for an average of 11 years, found an even greater reduction in prostate cancer deaths-29% over the longer follow-up period.12 To prevent 1 death from prostate cancer, the program needed to screen 1,055 men and treat 37 men.  More important, although deaths from prostate cancer were lower in the PSA screened group, there were no differences in overall mortality between the two groups.  In other words, the PSA screening reduced deaths from prostate cancer but did not save lives because those men were more likely to die from other causes.

Recent updates to a 2010 meta-analysis (which means researchers “pooled” data from many different but comparable studies) of six randomized, controlled prostate cancer screening trials (including the PLCO and ERSPC studies) further support the U.S. Preventive Services Task Force recommendations. Analysis of data on almost 330,000 men showed no significant difference in the risk of death from prostate cancer between the men who received PSA screenings and those who did not.13

A United Kingdom study published in 2018 in the prestigious medical journal JAMA involved over 160,000 men between the ages of 50 to 59 years. The study found that a one-time PSA screen increased the chances of diagnosing prostate cancer, but did not change the chances of dying from prostate cancer. Over a 10-year period, about 4.3% of men who had a one-time PSA test were diagnosed with prostate cancer compared to about 3.6% of men who did not have a PSA screen. The one-time PSA screen was able to detect prostate cancers that were lower grade and less likely to be dangerous.

Importantly, there was no evidence that having a PSA screen test saved lives. In men who were diagnosed with prostate cancer, the chances of dying from the prostate cancer within 10-years of diagnosis were about 3 in 10,000 (that’s less than half of a percent), and that was the case whether the men had a PSA screening or not. This means that a PSA test may detect more prostate cancers, but these are likely cancers that would not have been harmful. This study does not show that one-time screening with PSA would be helpful, and it could be harmful. The researchers have planned to look at these issues more closely in a longer term study.14

Benefits and Harms of Screening

The benefit of screening is that the disease is often curable with early detection (90% or better).  Common treatments like surgery or radiation aim to remove or kill all cancerous cells in the prostate.  If the cancer spreads beyond the prostate before it is treated, it is often fatal.  However, the cancer usually grows so slowly that it is often equally safe to wait until there are symptoms before attempting to diagnose prostate cancer. Symptoms of prostate cancer might include urinary problems, difficulty having an erection, or blood in the urine or semen.

The harms of screening include 1) inaccurate results leading to unnecessary biopsies and complications, and 2) complications from unnecessary treatment. Even if a man has prostate cancer, if he does not have symptoms he may not need to be treated. Experts estimate that between 18% and 85% of prostate cancers detected by these screening tests would never become advanced enough to harm the patient.  This wide range of uncertainty, however (is it less than 1 out of 5 or more than 4 out of 5?) just adds to the confusion.

Unnecessary treatment costs a lot of money, but the main concern is the complications, which include serious and long-lasting problems, such as urinary incontinence and erectile dysfunction.15

Long before the Task Force made its recommendation, many doctors and patients questioned whether annual prostate cancer screenings were a good idea, since the disease is rarely fatal. Many also question whether treating early prostate cancer, the kind of prostate cancer screening tests mostly find, is a good idea. Treating early prostate cancer does not appear to help men live longer, and for many it drastically reduces their quality of life.

Doctors and scientists are searching for better tests for prostate cancer detection. Many experts believe that a family history of prostate cancer or other cancers should influence how often a man chooses to get PSA screening.  However, the studies described below, which led to the Task Force’s recommendation against PSA screening, suggest that annual screenings for all men are not a good idea.

Is Surgery Effective for Men with Early-Stage Prostate Cancer?

When they hear the word “cancer,” many men want it treated immediately no matter how slow it is growing or how unlikely it is to be fatal. The question is: if found in its early stages, should prostate cancer be treated?  The answer to that question has changed in the last decade, with approximately 60% of U.S. men with low-risk prostate cancer choosing “active surveillance” in 2018, compared to less than 20% eight years earlier.16 Active surveillance, also called “watchful waiting” includes careful monitoring of the cancer by the physician, rather than surgery, radiation, or other treatment. The percentage of men choosing monitoring instead of treatment is even higher in Sweden and Australia.

The evidence supporting active surveillance is more than a decade old. In July 2012, a study by researchers at the Department of Veterans Affairs was published in the New England Journal of Medicine, examining the effectiveness of surgery in men with early-stage prostate cancer.17 Known as the Prostate Cancer Intervention versus Observation Trial, or PIVOT, the study compared surgical removal of the prostate with no prostate cancer treatment. The 731 men who participated in the study, with an average age of 67, were randomly assigned to one of the two groups and followed for 8 to 15 years. All the men were enrolled between 1994 and 2002, with a final check-up taking place in 2010. Men in both groups went to the doctor every six months during the study, and men in the observation-only group were offered palliative therapy (which focuses on reducing suffering) or chemotherapy to relieve symptoms due to the cancer spreading to other parts of the body. Neither therapy can eliminate the cancer and, therefore, are not treatments.

The findings suggest that prostate cancer surgery does not save the lives of men with early-stage prostate cancer. Only 7% of the participants died of prostate cancer or from treatment during the study: 21 or 5.8% of those had their prostate removed and 31 (8.4%) who did not undergo surgery. The difference between the surgery and observation groups was not statistically significant, which means that the smaller number who died in the surgery group could have been due to chance. The prostate cancer spread to the bone in 4.7% of the surgery patients and to 10.6% of the observation or no-treatment group. Even when cause of death wasn’t limited to prostate cancer, the two groups died at about the same rate: 47% of the men who had surgery died during the study period as compared with 50% in the observation group.

The only men who benefited from the surgery were those with a PSA of 10 ng per milliliter or higher and men with riskier tumors: their overall risk of dying during the study period — not necessarily from prostate cancer — was lower than in the observation group. Surgery reduced the risk of dying from any cause by 13.2% among men with a PSA of 10 ng per milliliter or higher. For men with intermediate risk tumors (determined by a PSA value of 10.1 to 20.0 ng per milliliter, a score of 7 on the Gleason scale, or a stage T2b tumor), surgery reduced their risk of dying by 12.6%, but for men with high risk tumors, the reduction in risk by 6.7% was not statistically significant. That means it could have happened by chance.

In September 2016, the prestigious New England Journal of Medicine published a 10-year study by researchers from University of Oxford, which provided solid evidence that neither surgery nor radiation treatments save lives.18 The study compared the death rates of three patient groups: surgery, radiation, and active monitoring, which is sometimes called active surveillance. Between 1999 and 2009, the study randomly assigned 1643 men with diagnosed prostate cancer to the three groups to receive radical surgery (553 men), radical radiotherapy (545), or active monitoring (545). Unlike the PIVOT study, patients in the “active monitoring group” underwent tests to determine if their prostate cancer had progressed; these were conducted every 3 months for the first year, and every 6 to 12 months after that. The patients had an average (median) of 10 years of follow-up.

At the final check-up, 169 men had died, and there was no significant difference among the three groups of prostate cancer patients. Only 17 of these were deaths from prostate cancer: 5 in the surgery group, 4 in the radiotherapy group, and 8 in the active-monitoring group. However, prostate cancer was more likely to progress or spread in the group of men who were monitored rather than treated.

This 2016 study was the first to compare the effectiveness of surgery, radiotherapy and active monitoring. The findings suggest that treatment does not improve the chances of a man living longer, since most of the men will be dying of other causes rather than prostate cancer. Since prostate cancer treatment can cause serious side effects such as erectile dysfunction and incontinence, active monitoring is now recognized as a reasonable option. In fact, due to studies like this, active monitoring (also called active surveillance) is considered the preferred option for most men with low-risk prostate cancer.19 The number of men in the United States who receive active monitoring instead of active treatment has been increasing in recent years. In 2010, only 13% of men with prostate cancer received active monitoring, compared to 33% of men in 2015.

One small study found that high intensity exercise may be beneficial for men undergoing active monitoring. The study found that men who ran on a treadmill for 40 minutes, 3 times a week for 12 weeks had lower PSA levels after the 12 weeks than before they started the exercise regimen, but that was not true for men who did not do the exercise regimen. The researchers note that exercise increases cardiorespiratory fitness, which could inhibit the progression of prostate cancer for men on active monitoring.20

Unfortunately, a 2020 study of over 80,000 men with low risk, localized prostate cancer found that active monitoring is not equally common across all regions of the United States and across all men.19 Men with Medicaid, as well as men living in counties where fewer residents have a college education, were less likely to receive active monitoring. Although rates of active monitoring were the same for Black and White men, the study found that Hispanic men were less likely to receive it. The researchers could not identify why this ethnic difference exists, but they suggested that it may be due to factors such as differences in how often the option is offered by doctors and patients’ preferences. The study also found that single men were more likely to use active monitoring than married men.

Since prostate cancer treatment can cause serious side effects such as erectile dysfunction and incontinence, active monitoring seems to be a reasonable option for many men, especially those with lower risk prostate cancers.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

The National Center for Health Research is a nonprofit, nonpartisan research, education and advocacy organization that analyzes and explains the latest medical research and speaks out on policies and programs. We do not accept funding from pharmaceutical companies or medical device manufacturers. Find out how you can support us here.

References

  1. American Cancer Society. Key Statistics for Prostate Cancer. Cancer.org. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Updated January 2021. 
  2. National Cancer Institute. Cancer Stat Facts: Prostate Cancer. Seer.cancer.gov. https://seer.cancer.gov/statfacts/html/prost.html. 
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