Radical Prostatectomy verses Active Surveillance for Early Stage Prostate Cancer

Early Stage Prostate Cancer is Increasingly Managed by a Program of Active Surveillance

Charles H. Weaver, MD
7–11 minutes
Home » Prostate Cancer » Radical Prostatectomy verses Active Surveillance for Early Stage Prostate Cancer

The widespread use of PSA testing has resulted in a dramatic increase in the diagnosis and treatment of prostate cancer. Prostate cancer often progresses slowly over 10-15 years, and many men die of causes other than the cancer. In addition, treatments for prostate cancer can have adverse effects on sexual, urinary, or bowel function. In men with early-stage prostate cancer radical prostatectomy has been shown to reduce the risks of metastasis (cancer spread) and disease progression when compared to an approach of “watchful waiting” but using active surveillance not all men will require surgery.”1-11

About Early-Stage Prostate Cancer

The prostate is a gland of the male reproductive system, which is responsible for producing some of the fluid that transports the sperm during male ejaculation. Prostate cancer is a disease in which cancer cells form in the tissues of the prostate. Early-stage prostate cancer refers to prostate cancer that has not visibly spread from the prostate (stage I or II) and the outlook for men with early-stage disease continues to improve and over the past 20 years overall survival rates for all stages of prostate cancer have improved dramatically. The treatment of early-stage prostate cancer can be confusing because the evidence is mixed that surgical treatment prolongs survival compared with deferred treatment and active surveillance.

Current treatment options for early-stage prostate cancer include

Active Surveillance “Watchful Waiting”

Watchful waiting was a strategy that delayed the treatment of a “slow growing” cancer until there were signs of cancer progression. Early evidence suggested that this approach could produce similar survival rates compared with surgery or radiation in some men and watchful waiting avoided the side effects of more aggressive treatment. Surgery can cause lasting side effects, such as impotence and incontinence.

A strategy of active surveillance has replaced watchful waiting and instead tracks the cancer’s status. Active surveillance consists of following routine PSA tests, DREs (Digital Rectal Exams), biopsies, and imaging (MRI) to determine if the cancer is growing or getting more aggressive. If that happens, then surgery or radiation is considered. This approach can help some men avoid unnecessary treatment and potentially long-lasting side effects but requires regular evaluation by a urologist.

As our understanding of prostate cancer improves, more men with what doctors define as “low-risk”, early-stage prostate cancer are choosing active surveillance instead of immediate treatment. Before 2010, only about 7% of men chose not to have their low-risk disease treated with surgery or radiation. Currently over 40% of men choose active surveillance, and 75% of men over age 75 pursue an active surveillance approach.3 Harvard researchers have also found that men evaluated by a multi-disciplinary team of experts compared to a single practitioner are twice as likely to opt for active surveillance.4,5

Comparine Radical Prostatectomy vs Active Surveillance

In one of the earliest pivotal clinical trials researchers randomly assigned 695 men diagnosed with clinically detected early-stage prostate cancer to receive treatment with either a radical prostatectomy (347) or watchful waiting (348). After 29 years of follow up a total of 261 of the 347 men in the radical-prostatectomy group and 292 of the 348 men in the watchful-waiting group had died; 71 deaths in the radical-prostatectomy group and 110 in the watchful-waiting group were due to prostate cancer for an absolute difference in risk of 11.7 percentage points. The number needed to treat to avert one death from any cause was 8.4. At 23 years, a mean of 2.9 extra years of life were gained with radical prostatectomy. The researchers concluded that men with clinically detected, localized prostate cancer and a long-life expectancy benefited from radical prostatectomy, with a mean of 2.9 years of life gained.6

Subsequently, The Prostate Cancer Intervention versus Observation Trial (PIVOT) reported that at 19 years of follow-up, the relative risk of death from prostate cancer was similar, but the absolute difference in risk was only 4 percentage points. A secondary analysis of the data revealed a difference between the two treatment approaches – PSA levels. In men with a PSA value higher than 10 nanograms per milliliter of blood, surgery reduced the risk of death by 33% compared with observation. In men with high PSA scores, there were 13% fewer deaths with surgery compared with observation.5

Further analyses showed that men treated with radical prostatectomy less frequently required androgen-deprivation therapy and other palliative treatments. The researchers also found that for patients under 65 years old, the risk of any-cause mortality for the prostatectomy group was 50% that of the watchful waiting group. With low risk or intermediate risk disease patients, prostatectomy showed a relative risk of 57% and 71%, respectively. The investigators also noted that, given the large proportion of long-term survivors in the watchful waiting group who never required palliative treatment, watchful waiting is a viable treatment alternative with adequately selected groups. Men diagnosed at a younger age and those with higher risk features benefit the most from treatment with prostatectomy.

In contract to the earlier studies The Prostate Testing for Cancer and Treatment (ProtecT) trial involved only PSA-detected prostate cancers and the comparison group was not “watchful waiting” but active surveillance where the goal was to compare immediate radical treatment with delayed curative treatment in patients for whom it is indicated; in theory, this should reduce the possibility of finding any substantial effect from radical prostatectomy.14

Death from prostate cancer occurred in 3.1% in the men treated with active surveillance, 2.2% for prostatectomy, and 2.9% with radiation therapy. Metastases developed in 51 men (9.4%) in the active surveillance group, in 26 (4.7%) in the prostatectomy group, and in 27 (5.0%) in the radiotherapy group.

Long-term androgen-deprivation therapy was initiated in ~ 13% of those undergoing surveillance compared with 7% for surgery, and clinical progression occurred in 26% vs 11% respectively. In the active surveillance group 24% survived without any prostate cancer treatment at the end of follow-up. The study authors concluded “after 15 years of follow-up, prostate cancer–specific mortality was low regardless of the treatment assigned. Thus, the choice of therapy involves weighing trade-offs between benefits and harms associated with treatments for localized prostate cancer.”

Despite the data indicating that surgery does not reduce mortality for all men with early prostate cancer, some men feel better about treating it surgically. Choosing between surgery and active surveillance is a highly personal decision. Surgery can provide immediate relief from the fear of cancer progression; however, it can also come with serious and long-term side effects. While men who choose surveillance avoid those side effects, they may also live with constant fear regarding their cancer. It’s important for men to discuss all of their treatment options with their physician. Surgery may be appropriate for some men, especially those with higher PSA levels.9,10

Who Benefits from Active Surveillance?

Most men with PSA detected early-stage prostate cancer can benefit from a program of active surveillance. The goal is to determine which men with early prostate cancer are at a higher risk of developing cancer progression and can benefit from surgery based upon factors associated with their cancer. It is important that patients with early prostate cancer be evaluated by a multi-specialty team to best understand their individual risks and the risk and benefit of all treatment options.

John Hopkin’s researchers found that for selected men with very low-risk prostate cancer, active surveillance is safe and allows men to avoid or delay treatment with surgery or radiation therapy. Men undergoing active surveillance received regular follow-up that included annual prostate biopsies and curative treatment was recommended if a follow-up biopsy suggested higher-risk disease. Curative treatment was also an option if the men simply changed their minds about remaining on active surveillance.

  • Low-risk disease: Stage T1, Gleason score 2-6 and PSA <10 ng/mL)7
  • Life expectancy greater than 10 years.

After 15 years of follow up the probability of remaining on active surveillance was 81% after two years, 59% after five years, and 41% after 10 years.8 None of the men developed distant metastases, and there were no prostate cancer deaths. The researchers concluded “For carefully selected men, active surveillance with curative intent appears to be a safe alternative to immediate intervention. Limiting surveillance to very-low-risk patients may reduce the frequency of adverse outcomes.”

Men diagnosed with low-risk prostate cancer who choose active surveillance instead of initial treatment may also enjoy a better quality of life and those managed by watchful waiting without hormonal treatment reported the highest quality of life. Importantly men who choose to delay treatment for early prostate cancer do not experience increased anxiety from living with the disease.10,11

References

  1. Klotz L, Vesprini D, Loblaw A. Long term follow-up of a large active surveillance cohort. Presented at the 2014 EAU Congress in Stockholm Sweden. Abstract 26.
  2. Axelson A, Holmberg L, Ruutu M, et al. Radical prostatectomy versus watchful waiting in early prostate cancer. The New England Journal of Medicine. 2005;352: 1977-1984.
  3. Cooperberg MR, Carroll PR. Trends in Management for Patients With Localized Prostate Cancer, 1990-2013. Journal of the American Medical Association. 2015;314(1):80-82. doi:10.1001/jama.2015.6036.
  4. Aizer AA, Paly JJ, Zietman AL, et al. Multidisciplinary care and pursuit of active surveillance in low-risk prostate cancer. Journal of Clinical Oncology. Published early online July 30, 2012. doi: 10.1200/JCO.2012.42.8466
  5. Wilt TJ, Jones KM, Barry MJ, et al. Follow-up of prostatectomy versus observation for early prostate cancer. N Engl J Med 2017;377:132-142.
  6. https://www.nejm.org/doi/full/10.1056/NEJMoa180780
  7. Stattin P, Holmberg E, Johansson JE, et al. Outcomes in localized prostate cancer: National Prostate Cancer Register of Sweden follow-up study. Journal of the National Cancer Institute [early online publication]. June 18, 2010.
  8. Reference: Tosoian JJ, Trock BJ, Landis P et al. Active surveillance program for prostate cancer: an update of the Johns Hopkins experience. Journal of Clinical Oncology. Early online publication April 4, 2011.
  9. Hayes JH, Ollendorf DA, Pearson SD, et al. Active surveillance compared with initial treatment for men with low-risk prostate cancer. JAMA. 2010;304(21):2373-2380. doi: 10.1001/jama.2010.1720.
  10. van den Bergh RCN, Essink-Bot ML, Roobol MJ, et al. Anxiety and distress during active surveillance for early prostate cancer. Cancer. [early online publication]. July 27, 2009. DOI: 10.1002/cncr.24446.
  11. Draisma G, Etzioni R, Tsodikov A, et al. Lead time and overdiagnosis in prostate-specific antigen screening: Importance of methods and context. Journal of the National Cancer Institute. 2009; 101:374-383.
  12. Klotz L, Vesprini D, Loblaw A. Long term follow-up of a large active surveillance cohort. Presented at the 2014 EAU Congress in Stockholm Sweden. Abstract 26
  13. https://www.nejm.org/doi/full/10.1056/NEJMoa1606220?query=featured_home
  14. https://www.nejm.org/doi/full/10.1056/NEJMoa2214122

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