# PIVOT (Prostate Cancer Intervention Versus Observation Trial)

Source: https://onco.cc/trials/pivot/  
OnCo record `pivot` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In men whose prostate cancer was found by a blood test, having the operation did not clearly help them live longer, and it left many more of them incontinent or unable to get an erection.

## Summary

PIVOT randomised 731 men with localised prostate cancer, most of it detected by PSA testing, to radical prostatectomy or observation between November 1994 and January 2002, and followed them through August 2014.

Over 19.5 years of follow-up (median 12.7 years), 223 of 364 men (61.3 percent) assigned surgery and 245 of 367 (66.8 percent) assigned observation died: absolute difference 5.5 percentage points (95 percent confidence interval -1.5 to 12.4), hazard ratio 0.84 (0.70 to 1.01), p=0.06. Death attributed to prostate cancer or its treatment occurred in 27 men (7.4 percent) after surgery and 42 (11.4 percent) under observation: absolute difference 4.0 percentage points (-0.2 to 8.3), hazard ratio 0.63 (0.39 to 1.02), p=0.06. Neither reached significance.

The subgroup signal was in intermediate-risk disease, where surgery was associated with an absolute reduction in all-cause mortality of 14.5 percentage points (2.8 to 25.6), against 0.7 points (-10.5 to 11.8) in low-risk and 2.3 points (-11.5 to 16.1) in high-risk disease (p=0.08 for interaction).

What surgery reliably did was reduce treatment for progression, by 26.2 percentage points (19.0 to 32.9), almost all of it for asymptomatic local or PSA progression. What it reliably cost was continence and erections: urinary incontinence and erectile and sexual dysfunction were each more frequent after surgery through 10 years, and limitations in activities of daily living were greater through 2 years.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-25
- Also known as: PIVOT; Prostate Cancer Intervention Versus Observation Trial; CSP #407
- Registry id: NCT00007644
- Phase: 3
- Setting: Localised prostate cancer, largely detected by PSA testing, in United States veterans: radical prostatectomy versus observation, with all-cause mortality as the primary outcome and prostate cancer mortality as the main secondary outcome, followed for nearly 20 years
- Sponsor: United States Department of Veterans Affairs Cooperative Studies Program and the National Cancer Institute
- Enrolled: 731
- Result: All-cause mortality 61.3 against 66.8 percent (hazard ratio 0.84, 95 percent confidence interval 0.70 to 1.01, p=0.06) and prostate cancer mortality 7.4 against 11.4 percent (0.63, 0.39 to 1.02, p=0.06); neither significant. Incontinence and erectile dysfunction were greater after surgery through 10 years.
- Outcomes: Death from any cause (median 12.7 years): Radical prostatectomy 61.3% vs Observation 66.8%, HR 0.84; Death from prostate cancer or its treatment: Radical prostatectomy 7.4% vs Observation 11.4%, HR 0.63
- Replication: Consistent with ProtecT, which found prostate cancer mortality of 3.1, 2.2 and 2.9 percent at 15 years across monitoring, surgery and radiotherapy in a screen-detected population; SPCG-4, in clinically detected disease, found a clear survival benefit for surgery.

## Sources

- ClinicalTrials.gov NCT00007644: https://clinicaltrials.gov/study/NCT00007644
- PIVOT extended follow-up (New England Journal of Medicine 2017): https://doi.org/10.1056/NEJMoa1615869

## Connected records

- cancers: [Localised prostate cancer, intermediate risk](https://onco.cc/cancers/prostate-intermediate-risk/), [Localised prostate cancer, very low and low risk](https://onco.cc/cancers/prostate-low-risk/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Active surveillance](https://onco.cc/technologies/active-surveillance/), [Robotic & minimally invasive surgery](https://onco.cc/technologies/robotic-surgery/)
- terms: [Active surveillance and observation](https://onco.cc/terms/active-surveillance-term/), [Choosing treatment for localised prostate cancer: what each option costs](https://onco.cc/terms/prostate-treatment-choice-localised/), [PSA (prostate-specific antigen)](https://onco.cc/terms/psa/), [Quality of life and patient-reported outcomes (QoL, PRO)](https://onco.cc/terms/qol-pro/), [Radical prostatectomy](https://onco.cc/terms/prostatectomy/)
- trials: [ProtecT](https://onco.cc/trials/protect/), [SPCG-4 (Scandinavian Prostate Cancer Group Study 4)](https://onco.cc/trials/spcg-4/)

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