Results from the Prostate Intervention Versus Observation Trial (PIVOT-1), a randomized trial in the United States that compared radical prostatectomy with watchful waiting, have not been reported. The PIVOT used overall mortality as its primary endpoint. (Refer to the Stage II Prostate Cancer treatment section of this summary for more information.)
Cryotherapy is also under evaluation for the treatment of localized prostate cancer. There is limited evidence on its efficacy and safety compared to the more commonly used local therapies, and the technique is evolving in an attempt to reduce local toxicity and normal tissue damage (see below). The quality of evidence on efficacy is low, currently limited to case series of relatively small size, short follow-up, and surrogate outcomes of efficacy.
Complications of radical prostatectomy can include urinary incontinence, urethral stricture, impotence,  and the morbidity associated with general anesthesia and a major surgical procedure. (For more information on impotence, refer to the PDQ summary on Sexuality and Reproductive Issues.) An analysis of Medicare records on 101,604 radical prostatectomies performed from 1991 to 1994 showed a 30-day operative mortality rate of 0.5%, a rehospitalization rate of 4.5%, and a major complication rate of 28.6%; over the study period, these rates decreased by 30%, 8%, and 12%, respectively. Prostatectomies done at hospitals where fewer prostatectomies were performed were associated with higher rates of 30-day postoperative mortality, major acute surgical complications, longer hospital stays, and higher rates of rehospitalization than those done at hospitals where more prostatectomies were performed. Morbidity and mortality rates increase with age.[31,43] Comorbidity, especially underlying cardiovascular disease and a history of stroke, accounts for a portion of the age-related increase in 30-day mortality. In a cohort of all men with prostate cancer who underwent radical prostatectomy from 1990 to 1999 in Ontario, 75-year-old men with no comorbidities had a predicted 30-day mortality of 0.74%. Thirty-day surgical complication rates also depended more on comorbidity than age (i.e., about 5% vs. 40% for 0 vs. 4 or more underlying comorbid conditions).
In one large case series of men undergoing the anatomic (nerve-sparing) technique of radical prostatectomy, approximately 6% of the men required the use of pads for urinary incontinence, but an unknown additional proportion of men had occasional urinary dribbling. About 40% to 65% of the men who were sexually potent before surgery retained potency adequate for vaginal penetration and sexual intercourse. Preservation of potency with this technique is dependent on tumor stage and patient age, but the operation probably induces at least a partial deficit in nearly all patients.
A national survey of Medicare patients who underwent radical prostatectomy in 1988 to 1990 reported more morbidity than in the case series. In that survey, more than 30% of the men reported the need for pads or clamps for urinary wetness, and 63% of all patients reported a current problem with wetness. About 60% of the men reported having no erections since surgery; about 90% of the men had no erections sufficient for intercourse during the month before the survey. (For more information on erectile dysfunction, refer to the Sexuality and Reproductive Issues summary.) About 28% of the patients reported follow-up treatment of cancer with radiation therapy and/or hormonal therapy within 4 years after their prostatectomy.