📃 Paper Title: Radical Prostatectomy versus Observation for Localized Prostate Cancer or The PIVOT Study (Prostate Cancer Intervention versus Observation Trial)
🧍 Author: Wilt
🕒 Year: 2017
📚 Journal: New England Journal of Medicine
🌎 Country: USA
ㅤContext to the study:
Which trial compared radical prostatectomy to observation in patients with localised prostate cancer?
ㅤ✅ Take-home message of study:
This randomised controlled trial included approximately 700 patients with localised prostate cancer; patients were assigned to surgery (radical prostatectomy) or observation and followed up for a median of 12.7 years. There was no significant difference in all-cause mortality or prostate cancer related mortality; surgery led to a 5.5% absolute reduction in all-cause mortality and 4.0% absolute reduction in prostate cancer mortality.
ㅤ Multi-centre Randomised controlled trial (RCT)
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Study participants:
731 participants (total)
Radical prostatectomy (n=364)
Observation (n=367)
Inclusion criteria:
Medically fit for radical prostatectomy
Clinically localised prostate cancer (negative results on a bone scan for metastatic disease); T1-T2NxM0
Any histological grade
Diagnosed within the previous 12 months
PSA < 50 ng/mL
age 75 years
life expectancy of at least 10 years
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Key study outcomes:
The median follow-up was 12.7 years (maximum follow-up 19.5 years)
Primary outcome:
All-cause mortality:
Surgery (radical prostatectomy): 61.3% vs. Observation: 66.8%
Absolute risk difference: 5.5%
Hazard ratio: 0.84
Did not reach statistical significance
Surgery demonstrated larger benefits in all-cause mortality in those classified as intermediate risk (14.5% absolute difference); but not low-risk (0.7%) or high-risk (2.3%)
Secondary outcome(s):
Death due to prostate cancer (prostate cancer mortality) or treatment:
Surgery: 7.4% vs. Observation: 11.4%
Absolute risk difference: 4.0%
Hazard ratio 0.63
Did not reach statistical significance
Disease progression:
30-day perioperative harms and prevalence of urinary incontinence and erectile and bowel dysfunction at 2 years
At median-follow up 10 years, 171 men assigned to radical prostatectomy (47.0%) and 183 men assigned to observation (49.9%) died (hazard ratio, 0.88, 95% confidence interval 0.71-1.08, P=0.22).
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Study Limitations:
Struggled to recruit initial target of 2,000 men, later revised to 740 men over 7-years
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