Trial Information

CSP #407 - Prostate Cancer Intervention Versus Observation Trial (PIVOT): A Randomized Trial Comparing Radical Prostatectomy Versus Palliative Expectant Management for the Treatment of Clinically Localized Prostate Cancer

Primary Hypothesis: To determine whether radical prostatectomy or expectant management is
more effective in reducing mortality and extending life.

Secondary Hypothesis: To determine which treatment strategy is superior in terms of prostate
specific cancer mortality, quality of life, occurrence or recurrence of symptoms and need
for cancer treatment.

Intervention: 1) Radical prostatectomy, plus intervention for evidence of disease
persistence or recurrence, 2) Expectant management with palliative therapy reserved for
symptomatic or metastatic disease progression.

Primary Outcomes: All cause mortality.

Study Abstract: Cancer of the prostate (CAP) is the most common nondermatologic and the
second most frequent cause of cancer deaths in men. No cure is currently possible for
disseminated disease. Cancer confined to the prostate is believed to be curable, with the
most frequently recommended therapy being surgical extirpation of the tumor with radical
prostatectomy. However, despite increasing cancer detection and aggressive surgical
treatment, population-based mortality rates from prostate cancer have not decreased, neither
nationally nor in states with high rates of radical prostatectomy. Existing evidence does
not demonstrate the superiority of this procedure compared to expectant management in the
treatment of localized prostate cancer. Data from case series suggest that either treatment
approach provides equivalent all-cause as well as prostate cancer specific mortality. The
only randomized trial was limited by a small sample size but the results favored expectant
management.

Radical prostatectomy provides potentially curative removal of the cancer. However, it
subjects patients to the morbidity and mortality of the surgery and may be neither necessary
nor effective. Expectant management does not offer potential cure. However, it provides
palliative therapy for symptomatic or metastatic disease progression, avoids potentially
excessive and morbid interventions in asymptomatic patients, and emphasizes management
approaches for focus on relieving symptoms while minimizing therapeutic complications.

The primary objective of this study is to determine which of two strategies is superior for
the management of clinically localized CAP: 1) radical prostatectomy with early aggressive
intervention for disease persistence or recurrence, 2) expectant management with reservation
of therapy for palliative treatment of symptomatic or metastatic disease progression.
Outcomes include total mortality, CAP mortality, disease free and progression free survival,
morbidity, quality of life, and cost effectiveness.