ProtecT
The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer (Prostate Testing for Cancer and Treatment)
N = 1,643NCT02044172
- Population
- Men aged 50 to 69 years with clinically localized prostate cancer detected through PSA testing who agreed to randomization; more than one third had intermediate- or high-risk disease at diagnosis (15-year report)
- Design
- Between 1999 and 2009, 82,429 men aged 50 to 69 years in the United Kingdom had a PSA test; 2664 were diagnosed with localized prostate cancer and 1643 agreed to randomization to active monitoring, radical prostatectomy or external-beam radiotherapy. Primary outcome: prostate-cancer mortality (defined, in the 2016 patient-reported outcomes report, as deaths definitely or probably due to prostate cancer or its treatment; reported at a median of 10 years in 2016 and 15 years, range 11 to 21, in 2023). Secondary outcomes: progression, metastases, all-cause death and initiation of long-term androgen-deprivation therapy. Patient-reported outcomes were reported to 6 years (2016) and 7 to 12 years (2023).
- Primary endpoint
- Prostate cancer mortality
- Arms
- Active monitoring (reference arm) (control, n = 545): Active monitoring
- Radical prostatectomy (experimental, n = 553): Radical prostatectomy
- Radical radiotherapy (experimental, n = 545): Radical external-beam radiotherapy with neoadjuvant androgen deprivation
- People
- Hamdy FC, ProtecT Study Group
Δ Prostate cancer mortality−0.9 pointsΔ Metastases−4.7 pointsΔ Clinical progression−15.4 pointsΔ Long-term androgen-deprivation therapy started−5.5 pointsΔ 84-month Erections sufficient for intercourse−12 pointsΔ 144-month Nocturia−13 points
Show the numbers
| Endpoint | Analysis | Radical prostatectomy / Radical radiotherapy | Active monitoring (reference arm) | Effect |
|---|---|---|---|---|
| Prostate cancer mortalityRandomized men (n=1643); follow-up complete for 1610 (98%)Death from prostate cancer (primary outcome); proportion of men in each arm | long term-updatemedian follow-up 15 yearsHamdy 2023 | 2.2% | 3.1% | P=0.53P value is for the overall three-group comparison. 45 men (2.7%) died of prostate cancer: 17, 12 and 16 in the active-monitoring, prostatectomy and radiotherapy groups. Median follow-up 15 years (range 11 to 21). The 10-year primary analysis is recorded in the milestone facts because it was reported as events per 1000 person-years. |
| MetastasesRandomized men (n=1643); follow-up complete for 1610 (98%) | long term-updatemedian follow-up 15 yearsHamdy 2023 | 4.7% | 9.4% | Proportion of men who developed metastases (51, 26 and 27 men). The abstract gives no P value for this comparison. |
| Clinical progressionRandomized men (n=1643); follow-up complete for 1610 (98%) | long term-updatemedian follow-up 15 yearsHamdy 2023 | 10.5% | 25.9% | Proportion of men with clinical progression (141, 58 and 60 men). The abstract gives no P value for this comparison. |
| Long-term androgen-deprivation therapy startedRandomized men (n=1643); follow-up complete for 1610 (98%) | long term-updatemedian follow-up 15 yearsHamdy 2023 | 7.2% | 12.7% | Proportion of men who started long-term androgen-deprivation therapy (69, 40 and 42 men). The abstract gives no P value for this comparison. |
| Erections sufficient for intercourseRandomized participants who returned questionnaires (response rates above 80% for most measures); mixed-effects models | long term-updateDonovan 2023 | 18% at 7 y | 30% at 7 y | Patient-reported erections sufficient for intercourse at 7 years; the abstract states that all groups converged to low levels of potency by year 12. Radiotherapy was given with neoadjuvant androgen deprivation. |
| NocturiaRandomized participants who returned questionnaires (response rates above 80% for most measures); mixed-effects modelsVoiding at least twice per night, patient-reported | long term-updateDonovan 2023 | 34% at 12 y | 47% at 12 y | — |
| Faecal leakageRandomized participants who returned questionnaires (response rates above 80% for most measures); mixed-effects modelsPatient-reported faecal leakage | long term-updateDonovan 2023 | 12% at 12 y | 6% at 12 y | The abstract gives 6% for 'the other groups'; the same value is entered for prostatectomy and active monitoring. |
| Endpoint | Analysis | Radical prostatectomy / Radical radiotherapy | Active monitoring (reference arm) | Effect |
|---|---|---|---|---|
| Prostate cancer mortalityRandomized men (n=1643); follow-up complete for 1610 (98%)Death from prostate cancer (primary outcome); proportion of men in each arm | long term-updatemedian follow-up 15 yearsHamdy 2023 | 2.2% | 3.1% | P=0.53P value is for the overall three-group comparison. 45 men (2.7%) died of prostate cancer: 17, 12 and 16 in the active-monitoring, prostatectomy and radiotherapy groups. Median follow-up 15 years (range 11 to 21). The 10-year primary analysis is recorded in the milestone facts because it was reported as events per 1000 person-years. |
| MetastasesRandomized men (n=1643); follow-up complete for 1610 (98%) | long term-updatemedian follow-up 15 yearsHamdy 2023 | 4.7% | 9.4% | Proportion of men who developed metastases (51, 26 and 27 men). The abstract gives no P value for this comparison. |
| Clinical progressionRandomized men (n=1643); follow-up complete for 1610 (98%) | long term-updatemedian follow-up 15 yearsHamdy 2023 | 10.5% | 25.9% | Proportion of men with clinical progression (141, 58 and 60 men). The abstract gives no P value for this comparison. |
| Long-term androgen-deprivation therapy startedRandomized men (n=1643); follow-up complete for 1610 (98%) | long term-updatemedian follow-up 15 yearsHamdy 2023 | 7.2% | 12.7% | Proportion of men who started long-term androgen-deprivation therapy (69, 40 and 42 men). The abstract gives no P value for this comparison. |
| Erections sufficient for intercourseRandomized participants who returned questionnaires (response rates above 80% for most measures); mixed-effects models | long term-updateDonovan 2023 | 18% at 7 y | 30% at 7 y | Patient-reported erections sufficient for intercourse at 7 years; the abstract states that all groups converged to low levels of potency by year 12. Radiotherapy was given with neoadjuvant androgen deprivation. |
| NocturiaRandomized participants who returned questionnaires (response rates above 80% for most measures); mixed-effects modelsVoiding at least twice per night, patient-reported | long term-updateDonovan 2023 | 34% at 12 y | 47% at 12 y | — |
| Faecal leakageRandomized participants who returned questionnaires (response rates above 80% for most measures); mixed-effects modelsPatient-reported faecal leakage | long term-updateDonovan 2023 | 12% at 12 y | 6% at 12 y | The abstract gives 6% for 'the other groups'; the same value is entered for prostatectomy and active monitoring. |
Appears in
Sources
Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, et al. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016;375(15):1415-1424.
Hamdy FC, Donovan JL, Lane JA, Metcalfe C, Davis M, Turner EL, et al. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2023;388(17):1547-1558.
Donovan JL, Hamdy FC, Lane JA, Young GJ, Metcalfe C, Walsh EI, et al. Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment. NEJM Evid. 2023;2(4):EVIDoa2300018.