The management of early prostate cancer remains controversial. Although observational studies have shown that prostatectomy lowers rates of cancer progression compared with expectant management, no overall survival benefit has been demonstrated, even with more than 20 years of follow-up. Postoperative urinary incontinence and impotence rates have also dampened enthusiasm for surgical intervention. Holmberg and others from the Scandinavian Prostatic Cancer Group Study Number 4 reported the findings of a randomized, prospective trial comparing radical prostatectomy and watchful waiting in men with early prostate cancer.

Eligible subjects were men younger than 75 years with newly diagnosed prostate cancer. The cancer had to be at least moderately well differentiated on biopsy and limited to the prostate gland. Bone scans had to be negative, and the prostate-specific antigen level had to be below 50 ng per mL. A total of 695 men were randomized to undergo radical prostatectomy (n = 347) or watchful waiting (n = 348).

No adjuvant radiation therapy or chemotherapy was used. For local progression, transurethral resection of the prostate was recommended in the watchful-waiting group, and orchidectomy or gonadotropin-releasing hormone analog therapy was recommended in the surgical group. Treatment for disseminated disease was the same in both groups.

For a median of 6.2 years, the study subjects were followed annually for disease progression or death from prostate cancer or other cause. At five years of follow-up, the death rate for prostate cancer was 2 percent lower in the radical-prostatectomy group (2.6 percent) than in the watchful-waiting group (4.6 percent). After eight years of follow-up, the difference increased to 6.5 percent (7.1 percent for surgical treatment versus 13.6 percent for observation). At five years of follow-up, there was no significant difference between watchful waiting and prostatectomy in the development of distant metastases; after eight years, however, 13.9 percent fewer men in the radical-prostatectomy group had distant spread of prostate cancer (13.4 percent, compared with 27.3 percent in the watchful-waiting group). Overall survival was not significantly different in the two groups.

Holmberg and associates conclude that compared with watchful waiting, radical prostatectomy was associated with significant decreases in metastatic disease and disease-specific mortality over eight years of follow-up but with no significant difference in overall mortality.

editor's note: An accompanying article by Steineck and colleagues reported on a quality-of-life survey administered in this prostate cancer study population. Erectile dysfunction was more common after radical prostatectomy (80 percent) than with watchful waiting (45 percent). Urinary leakage was also more common (49 percent in the radical-prostatectomy group versus 21 percent in the watchful-waiting group).

This randomized, prospective study largely confirms the findings of previous observational studies. Surgery is associated with some reduction in cancer-related deaths and less metastatic spread. However, the large majority of men in the study remained unaffected over eight years of follow-up, regardless of treatment. Impotence occurs in most men after surgery; incontinence is also more common. After mulling over the data from the study, individual patients and physicians will undoubtedly still come to very different conclusions about the balance of risk and benefit for the use of radical prostatectomy in early prostate cancer.—B.Z.