Trial Outcomes & Findings for Prostate Cancer Intervention Versus Observation Trial (PIVOT) (NCT NCT00007644)

NCT ID: NCT00007644

Last Updated: 2020-02-24

Results Overview

Number of deaths from any cause.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 731 participants
• Primary outcome timeframe: From date of randomization until date of death from any cause, assessed until end of study, up to 16 years
• Results posted on: 2020-02-24

Participant Flow

Enrollment begain in November 1994 and ended in January 2002 with follow-up through January 2010. We recruited men from 44 Department of Veterans Affairs sites and 8 National Cancer Institute sites.

A total of 13,022 men were entered into study logs as potentially eligible. Based upon further chart review, 6707 met age, comorbidity and prostate cancer specific criteria and received detailed information about the study. From these, 5023 were considered likely to be eligible and a total of 731 men agreed to participate.

Participant milestones

Measure	Radical Prostatectomy Surgical removal of the prostate	Watchful Waiting Closely watching, waiting and treating symptoms if and when cancer progresses
Overall Study STARTED	364	367
Overall Study COMPLETED	364	367
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prostate Cancer Intervention Versus Observation Trial (PIVOT)

Baseline characteristics by cohort

Measure	Radical Prostatectomy n=364 Participants Surgical removal of the prostate	Watchful Waiting n=367 Participants Closely watching, waiting and treating symptoms if and when cancer progresses	Total n=731 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	122 Participants n=5 Participants	131 Participants n=7 Participants	253 Participants n=5 Participants
Age, Categorical >=65 years	242 Participants n=5 Participants	236 Participants n=7 Participants	478 Participants n=5 Participants
Age, Continuous	67.0 years STANDARD_DEVIATION 5.2 • n=5 Participants	66.8 years STANDARD_DEVIATION 5.6 • n=7 Participants	66.9 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	364 Participants n=5 Participants	367 Participants n=7 Participants	731 Participants n=5 Participants
Region of Enrollment United States	364 participants n=5 Participants	367 participants n=7 Participants	731 participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until date of death from any cause, assessed until end of study, up to 16 years

Number of deaths from any cause.

Outcome measures

Measure	Radical Prostatectomy n=364 Participants Surgical removal of the prostate Radical prostatectomy: Surgical removal of the prostate	Watchful Waiting n=367 Participants Closely watching, waiting and treating symptoms if and when cancer progresses
All Cause Mortality	171 Participants	183 Participants

Adverse Events

Radical Prostatectomy

Serious events: 171 serious events

Other events: 0 other events

Deaths: 0 deaths

Watchful Waiting

Serious events: 183 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Radical Prostatectomy n=364 participants at risk Surgical removal of the prostate	Watchful Waiting n=367 participants at risk Closely watching, waiting and treating symptoms if and when cancer progresses
General disorders Death	47.0% 171/364 • Number of events 171	49.9% 183/367 • Number of events 183

Other adverse events

Adverse event data not reported

Additional Information

Timothy Wilt, MD

Minneapolis VA Medical Center

Phone: 612-467-2158

Email: timothy.wilt@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place