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Radical Prostatectomy Reduces Prostate Cancer Mortality and Distant Metastases

  • Authors: News Author: Zosia Chustecka
    CME Author: Charles Vega, MD
  • CME Released: 8/19/2008
  • Valid for credit through: 8/19/2009
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Target Audience and Goal Statement

This article is intended for primary care clinicians, urologists, oncologists, and other specialists who care for men with prostate cancer.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  1. Describe the epidemiology of prostate cancer and its treatment.
  2. Compare watchful waiting and radical prostatectomy in the management of localized prostate cancer.


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  • Zosia Chustecka

    Zosia Chustecka is News Editor for Medscape Oncology. A veteran medical journalist based in London, UK, she has won a prize from the British Medical Journalists Association and is a pharmacology graduate. She has written for a wide variety of publications aimed at the medical and related health professions. She can be contacted at [email protected]


    Disclosure: Zosia Chustecka has disclosed no relevant financial relationships.


  • Brande Nicole Martin

    Brande Nicole Martin is the News CME editor for Medscape Medical News.


    Disclosure: Brande Nicole Martin has disclosed no relevant financial information.

CME Author(s)

  • Charles P Vega, MD

    Associate Professor; Residency Director, Department of Family Medicine, University of California, Irvine


    Disclosure: Charles Vega, MD, has disclosed an advisor/consultant relationship to Novartis, Inc.

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Radical Prostatectomy Reduces Prostate Cancer Mortality and Distant Metastases

Authors: News Author: Zosia Chustecka CME Author: Charles Vega, MDFaculty and Disclosures

CME Released: 8/19/2008

Valid for credit through: 8/19/2009


August 19, 2008 — Long-term results confirm that radical prostatectomy reduces prostate-cancer–specific mortality rates and the risk for distant metastases vs "watchful waiting" in men with localized prostate cancer.

These latest findings from the Scandinavian Prostate Cancer Group-4 (SPCG-4) are reported in the August 20 issue of the Journal of the National Cancer Institute. Lead author Anna Bill-Axelson, MD, from the University Hospital in Uppsala, Sweden, and colleagues point out that, to date, this is the only randomized trial to have shown a benefit for radical prostatectomy.

However, it is unclear how generalizable these results are to current prostate cancer patients in Western countries and especially in the United States, because men are now mostly diagnosed by screening for prostate-specific antigen (PSA). That was not the case for the men who took part in the SPCG-4 trial, which began in 1989 in Sweden. In that patient population, only 5% had their prostate cancer detected by PSA. The vast majority had palpable tumors, the researchers comment. In addition, the control group was observed with watchful waiting, whereas practice has now changed towards "active surveillance," which would also have an affect on the outcomes.

Nevertheless, the results from the SPCG-4 trial are "immensely important," comments an accompanying editorial by Timothy Wilt, MD, MPH, from the Minneapolis Veterans Administration Center for Chronic Disease Outcome Research in Minnesota.

"These results demonstrate that among men younger than 65 years whose prostate cancer is detected by methods other than PSA testing (eg, due to a digital rectal examination to evaluate urinary or other symptoms), cure with radical prostatectomy is possible, may be necessary, and should generally be recommended," Dr Wilt writes. "Results are less certain for men older than 65 years or with limited life expectancy due to comorbidities."

Latest Results Confirm Previous Findings

The SPCG-4 trial observed 695 men with clinically localized prostate cancer who were randomly assigned to either radical prostatectomy or watchful waiting.

The trialists last reported results in 2005, after a median follow-up of 8.2 years. At that time, they reported a relative reduction of 44% in prostate cancer mortality rates, 40% in the risk for metastases, and 26% in overall mortality rates in favor of radical prostatectomy.

The latest results, after a median follow-up of 10.8 years (range, 3 weeks to 17.2 years), confirm that finding. Analysis of these longer-term data showed a relative reduction of 35% in deaths from prostate cancer, 35% in the risk for metastases, and 18% in overall mortality rates in favor of radical prostatectomy.

The reductions in deaths from prostate cancer and of the risk for development of distant metastases were both statistically significant. At 12 years, 12.5% of men undergoing surgery vs 17.9% of men observed by watchful waiting had died from prostate cancer, giving a relative risk for 0.65 (P = .03). Also at 12 years, distant metastases were found in 19.3% men in the surgery group vs 26% of men in the watchful waiting group (relative risk, 0.65; P = .006).

Overall mortality rate in the 2 groups was not statistically different, although it favored surgery. At 12 years, 32.7% of men in the surgery group and 39.8% of men in the watchful waiting group had died (relative risk, 0.82; P = .09).

The cumulative incidence of death from prostate cancer remained constant beyond 9 years of follow-up, and the cumulative incidence of metastases remained constant beyond approximately 7 years of follow-up, the researchers comment.

A new and key finding from this latest analysis of the data is that almost all of the men in the radical prostatectomy group who died from prostate cancer had tumor growth outside of the prostate capsule, the researchers point out. Nearly half of the men who underwent surgery (132 [46%] of 284) were found to have extracapsular tumor growth, and they had a 14-fold higher risk for death from prostate cancer vs men without evidence of extracapsular growth (relative risk, 14.2; P < .001). "These men should be considered for postoperative radiotherapy," the researchers comment.

Ongoing Trials Will Provide More Data Soon

So far, the SPCG-4 study provides the only evidence from a randomized trial for the benefit of radical prostatectomy, the researchers point out.

Dr. Wilt notes that the only other randomized trial comparing surgery with watchful waiting, which began 40 years ago, failed to demonstrate a survival difference even at 23 years of follow-up (Scan J Urol Nephrol Suppl. 1995;172:65-72).

However, more data should be available soon, he comments. Nearing completion is the US Prostate Cancer Intervention Versus Observation Trial, which has also compared radical prostatectomy with watchful waiting, but expands on SPCG-4 by including PSA-detected tumors and African American men.

Further back are 2 other trials addressing similar clinical questions. The Prostate Testing for Cancer and Treatment study in the United Kingdom is comparing conformal radiotherapy, prostatectomy, and active surveillance, whereas the Standard Treatment Against Restricted Treatment trial, currently in a feasibility study in Canada, plans to compare early interventions of surgery, external beam radiation therapy, or brachytherapy with active surveillance.

Results from these trials will add to those from SPCG-4 and, together with hopefully other large trials in the field, will provide information that has been long lacking on how best to treat localized prostate cancer, Dr. Wilt comments.

However, until the results of these other trials are available, the SPCG-4 provides the only evidence from a randomized trial for the benefits of a radical prostatectomy, the researchers emphasize.

The SPCG-4 study was funded by the Swedish Cancer Society and the US National Institutes of Health. The study authors have disclosed no relevant financial relationships. Dr. Wilt has disclosed no relevant financial relationships.

J Natl Cancer Inst. 2008;100:1-11.

Clinical Context

Prostate cancer is the most common visceral malignant tumor in men, and an editorial by Wilt, which accompanies the current article, reviews the clinical effect of prostate cancer. The advent of routine testing for PSA doubled the number of men diagnosed with prostate cancer. Also, pathologists are grading prostate cancer to be more aggressive than they did in the past. These factors have led to high rates of intervention for prostate cancer, with approximately 60,000 radical prostatectomy procedures performed in the United States annually. Most men with prostate cancer who are younger than age 75 years receive radical prostatectomy.

Nonetheless, prostate cancer remains the second leading cause of male cancer mortality. The current study focuses on localized prostate cancer and reports on long-term outcomes of a comparison of treatment strategies of watchful waiting vs radical prostatectomy.

Study Highlights

  • Patients eligible for study participation were seen in 1 of 14 centers in Sweden, Iceland, or Finland. All subjects had localized prostate cancer (stage T1 or T2) and were younger than 75 years of age. Participants also had PSA levels less than 50 ng/mL and negative results on bone scan.
  • Study subjects were randomly assigned to receive radical prostatectomy or watchful waiting.
  • Participants were observed every 6 months during the first 2 years and annually thereafter. All examinations included PSA tests, and bone scans were performed regularly every 1 or 2 years.
  • The main outcomes of the study were overall mortality rate, death from prostate cancer, and the occurrence of distant metastases.
  • 695 men with a mean age of 65 years were observed for an average of 10.8 years. Baseline characteristics were similar between randomly assigned groups.
  • Only 12% of the study cohort had prostate tumors not detected by palpation.
  • Compliance to the randomly assigned treatment in both groups was good.
  • An interim analysis at a mean of 8.2 years of follow-up demonstrated that radical prostatectomy was superior to watchful waiting in all 3 main study outcomes.
  • In the current analysis, 137 men in the radical prostatectomy group had died at the end of follow-up vs 156 men in the watchful waiting group. The 18% difference between groups in this outcome was not statistically significant.
  • Rates of mortality from prostate cancer were 13.5% and 19.5% in the radical prostatectomy group and the watchful waiting group, respectively. The relative risk of 0.65 favoring radical prostatectomy in this outcome was significant.
  • In a similar fashion, radical prostatectomy was superior to watchful waiting in the risk for distant metastases (relative risk, 0.65).
  • Local recurrence or progression was nearly 24 times more common in the watchful waiting cohort vs the radical prostatectomy cohort.
  • Radical prostatectomy was also associated with lower rates of use of hormonal therapy and palliative treatments vs watchful waiting.
  • Baseline PSA score or Gleason score did not modify the main results of the study. However, a subgroup analysis of men younger than age 65 years demonstrated superior results for radical prostatectomy in overall mortality rates, death from prostate cancer, and the occurrence of distant metastases. For men older than age 65 years, there was no difference between study groups in any outcome.
  • Only 2 men without evidence of extracapsular tumor growth on radical prostatectomy died from prostate cancer during follow-up. Furthermore, there were no deaths from prostate cancer in participants with a Gleason score between 2 and 6.

Pearls for Practice

  • The routine use of PSA testing is associated with a doubling of the number of men diagnosed with prostate cancer. Most men younger than age 75 years with prostate cancer in the United States undergo radical prostatectomy, but prostate cancer remains the second leading cause of male cancer mortality.
  • In the current study of men with localized prostate cancer, radical prostatectomy reduced the risks for death from prostate cancer, distant metastasizes, and local recurrence and/or progression vs watchful waiting. However, rates of overall mortality were similar between the radical prostatectomy group and watchful waiting group.

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