PIVOT
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 3N = 731NCT00007644
- Population
- Men with localized prostate cancer detected during the early era of PSA testing (about 50% stage T1c; 40% low-risk, 34% intermediate-risk and 21% high-risk in the 2012 full text)
- Design
- From November 1994 through January 2002, 731 men with localized prostate cancer (mean age 67 years; median PSA 7.8 ng/mL) were randomly assigned to radical prostatectomy (364) or observation (367) and followed through January 2010 (2012 report) and August 2014 (2017 report). Primary outcome: all-cause mortality; main secondary outcome: prostate-cancer mortality (deaths from prostate cancer or treatment).
- Primary endpoint
- All-cause mortality
- Arms
- Observation (control, n = 367): Observation
- Radical prostatectomy (experimental, n = 364): Radical prostatectomy
- People
- Wilt TJ, Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group
All-cause mortalityHR 0.88 (95% CI 0.71–1.08)Δ All-cause mortality−2.9 pointsProstate cancer mortalityHR 0.63 (95% CI 0.36–1.09)Δ Prostate cancer mortality−2.6 pointsAll-cause mortalityHR 0.84 (95% CI 0.70–1.01)Δ All-cause mortality−5.5 points
Show the numbers
| Endpoint | Analysis | Radical prostatectomy | Observation | Effect |
|---|---|---|---|---|
| All-cause mortalityRandomized men (n=731) | primarymedian follow-up 10 yearsWilt 2012 | 47% | 49.9% | HR 0.88 (95% CI 0.71–1.08)P=0.22171 of 364 vs 183 of 367 men died; absolute risk reduction 2.9 percentage points. |
| Prostate cancer mortalityRandomized men (n=731)Death from prostate cancer or treatment; proportion of men in each arm | primarymedian follow-up 10 yearsWilt 2012 | 5.8% | 8.4% | HR 0.63 (95% CI 0.36–1.09)P=0.0921 vs 31 men; absolute risk reduction 2.6 percentage points. Secondary outcome. |
| All-cause mortalityRandomized men (n=731) | long term-updatemedian follow-up 12.7 yearsWilt 2017 | 61.3% | 66.8% | HR 0.84 (95% CI 0.70–1.01)P=0.06Follow-up up to 19.5 years (median 12.7 years). Deaths 223 of 364 vs 245 of 367; absolute difference in risk 5.5 percentage points (95% CI -1.5 to 12.4). |
| Prostate cancer mortalityRandomized men (n=731)Death attributed to prostate cancer or treatment; proportion of men in each arm | long term-updatemedian follow-up 12.7 yearsWilt 2017 | 7.4% | 11.4% | HR 0.63 (95% CI 0.39–1.02)P=0.06Follow-up up to 19.5 years (median 12.7 years). 27 vs 42 men; absolute difference in risk 4.0 percentage points (95% CI -0.2 to 8.3). |
| Endpoint | Analysis | Radical prostatectomy | Observation | Effect |
|---|---|---|---|---|
| All-cause mortalityRandomized men (n=731) | primarymedian follow-up 10 yearsWilt 2012 | 47% | 49.9% | HR 0.88 (95% CI 0.71–1.08)P=0.22171 of 364 vs 183 of 367 men died; absolute risk reduction 2.9 percentage points. |
| Prostate cancer mortalityRandomized men (n=731)Death from prostate cancer or treatment; proportion of men in each arm | primarymedian follow-up 10 yearsWilt 2012 | 5.8% | 8.4% | HR 0.63 (95% CI 0.36–1.09)P=0.0921 vs 31 men; absolute risk reduction 2.6 percentage points. Secondary outcome. |
| All-cause mortalityRandomized men (n=731) | long term-updatemedian follow-up 12.7 yearsWilt 2017 | 61.3% | 66.8% | HR 0.84 (95% CI 0.70–1.01)P=0.06Follow-up up to 19.5 years (median 12.7 years). Deaths 223 of 364 vs 245 of 367; absolute difference in risk 5.5 percentage points (95% CI -1.5 to 12.4). |
| Prostate cancer mortalityRandomized men (n=731)Death attributed to prostate cancer or treatment; proportion of men in each arm | long term-updatemedian follow-up 12.7 yearsWilt 2017 | 7.4% | 11.4% | HR 0.63 (95% CI 0.39–1.02)P=0.06Follow-up up to 19.5 years (median 12.7 years). 27 vs 42 men; absolute difference in risk 4.0 percentage points (95% CI -0.2 to 8.3). |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| All-cause mortality | 0.88 | 0.71–1.08 |
| Prostate cancer mortality | 0.63 | 0.36–1.09 |
| All-cause mortality | 0.84 | 0.7–1.01 |
| Prostate cancer mortality | 0.63 | 0.39–1.02 |
Appears in
Sources
Wilt TJ, Brawer MK, Jones KM, Barry MJ, Aronson WJ, Fox S, et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012;367(3):203-13.
Wilt TJ, Jones KM, Barry MJ, Andriole GL, Culkin D, Wheeler T, et al. Follow-up of Prostatectomy versus Observation for Early Prostate Cancer. N Engl J Med. 2017;377(2):132-142.