Know Cancer

forgot password

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

Phase 3
75 Years
Not Enrolling
Prostate Cancer

Thank you

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

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.

Inclusion Criteria:

- Patients with clinically localized CAP

- Diagnosis of Prostate Cancer within previous 6 months

- Age 75 years or younger

Exclusion Criteria:

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

All Cause Mortality

Outcome Time Frame:


Safety Issue:


Principal Investigator

Timothy J. Wilt, MD MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Minneapolis Veterans Affairs Medical Center


United States: Federal Government

Study ID:




Start Date:

June 1994

Completion Date:

January 2010

Related Keywords:

  • Prostate Cancer
  • cancer of the prostate (CAP)
  • cancer treatment
  • chronic diseases
  • expectant management
  • genitourinary
  • prostate
  • prostate specific cancer mortality
  • radical prostatectomy
  • Prostatic Neoplasms



VA Medical Center, Long Beach Long Beach, California  90822
VA Medical Center, Oklahoma City Oklahoma City, Oklahoma  73104
VA Medical Center, Providence Providence, Rhode Island  02908
VA Medical Center, Birmingham Birmingham, Alabama  35233
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock No. Little Rock, Arkansas  72114-1706
VA Medical Center, San Francisco San Francisco, California  94121
VA Greater Los Angeles HCS, Sepulveda Sepulveda, California  91343
James A. Haley Veterans Hospital, Tampa Tampa, Florida  33612
VA Medical Center, Boise Boise, Idaho  83702
Jesse Brown VAMC (WestSide Division) Chicago, Illinois  60612
Richard Roudebush VA Medical Center, Indianapolis Indianapolis, Indiana  46202-2884
VA Medical Center, Iowa City Iowa City, Iowa  52246-2208
VA Medical Center, Lexington Lexington, Kentucky  40502
Overton Brooks VA Medical Center, Shreveport Shreveport, Louisiana  71101
VA Ann Arbor Healthcare System Ann Arbor, Michigan  48113
Minneapolis VA Medical Center Minneapolis, Minnesota  55417
VA New Jersey Health Care System, East Orange East Orange, New Jersey  07018
VA Stratton Medical Center, Albany Albany, New York  12208
VA Medical Center, Bronx Bronx, New York  10468
New York Harbor Health Care System, Brooklyn Brooklyn, New York  11209
VA Western New York Healthcare System at Buffalo Buffalo, New York  14215
VA Medical Center, Syracuse Syracuse, New York  13210
VA Medical Center, Portland Portland, Oregon  97201
VA Pittsburgh Health Care System Pittsburgh, Pennsylvania  15240
VA Medical Center, Memphis Memphis, Tennessee  38104
VA North Texas Health Care System, Dallas Dallas, Texas  75216
Central Texas Veterans Health Care System Temple, Texas  76504
VA Medical Center, Hampton Hampton, Virginia  23667
VA Puget Sound Health Care System, Seattle Seattle, Washington  98108
VA Medical Center, Clarksburg Clarksburg, West Virginia  26301
Wlliam S. Middleton Memorial Veterans Hospital, Madison Madison, Wisconsin  53705