ProtecT
Showed that men with screen-detected prostate cancer die of it rarely, whether monitored or treated, establishing active surveillance.
1,643 men; 15-year prostate-cancer mortality ~3% in all arms (NEJM 2023); treatment halved metastasis but at the cost of side effects; ~60% of monitoring patients eventually treated.
Setting
PSA-detected localised prostate cancer: active monitoring vs prostatectomy vs radiotherapy
Phase
Phase 3
Sponsor
UK NIHR (Oxford, Bristol)
Registry
Headline result
15-year prostate-cancer mortality 3.1% (monitoring), 2.2% (surgery), 2.9% (radiotherapy); no significant difference.
Reported
2016
Enrolled
1643
Replication
Consistent with PIVOT and SPCG-4 in showing very low mortality from low- and intermediate-risk disease under conservative management.
In plain words
What these results mean for people, not percentages
Prostate-cancer-specific mortality at 15 yearsprimarysurvival endpoint
- 3.1 vs 2.2 out of 100 alive at 15 years with Active monitoring compared with Prostatectomy; 0.9 more per 100.
- Roughly one extra person helped for every 111 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Other groups: Radiotherapy 2.9 of 100.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: PSA-detected localised prostate cancer: active monitoring vs prostatectomy vs radiotherapy. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,643 participants enrolled.
Prostate-cancer-specific mortality at 15 yearsprimary
Active monitoring3.1 of 100
n = 545
Prostatectomy2.2 of 100
n = 553
Radiotherapy2.9 of 100
n = 545
No significant difference between arms
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Prostate-cancer-specific mortality at 15 yearsprimary | Active monitoring | 545 | 3.1% | — | — | link |
| Prostatectomy | 553 | 2.2% | ||||
| Radiotherapy | 545 | 2.9% |
Replication
Consistent with PIVOT and SPCG-4 in showing very low mortality from low- and intermediate-risk disease under conservative management.