Clinical trial · Interventional
Prostate Testing for Cancer and Treatment
The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer
NCT02044172CI-TRIAL-00062138ProtecTactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor may not need treatment until it progresses. In this case, active surveillance may be sufficient. It is not yet known which treatment regimen is more effective for localized prostate cancer. PURPOSE: This randomized phase III trial is studying active monitoring to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active monitoring | Other | — | UNRESOLVED |
| Conformal radiation therapy | Radiation | — | UNRESOLVED |
| Radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Radical prostatectomy
- description
- Radical prostatectomy
- interventionNames
- Procedure: Radical prostatectomy
- type
- ACTIVE_COMPARATOR
- label
- Conformal radiation therapy
- description
- Conformal radiation therapy External beam radiation therapy
- interventionNames
- Radiation: Conformal radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Active monitoring
- description
- Active monitoring of prostate specific antigen levels and disease surveillance
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: Fit for the treatments and estimates life expectancy of 10 years Registration with eligible primary care practice Exclusion Criteria: Unable to give written informed consent. Concomitant or past malignancy.
References
Publications (17)
- BACKGROUNDLane JA, Hamdy FC, Martin RM, Turner EL, Neal DE, Donovan JL. Latest results from the UK trials evaluating prostate cancer screening and treatment: the CAP and ProtecT studies. Eur J Cancer. 2010 Nov;46(17):3095-101. doi: 10.1016/j.ejca.2010.09.016. PMID 21047592
- DERIVEDSushentsev N, Warren AY, Colling R, Verrill C, Pazukhina E, Blyuss O, Zaikin A, Seibert TM, Barrett T, Oxley J, Mills IG, Bryant RJ, Lane JA, Donovan JL, Neal DE, Hamdy FC. Long-term outcomes of cribriform-positive and cribriform-negative prostate cancer treated with radical prostatectomy in the ProtecT trial. BJU Int. 2026 Jun;137(6):984-991. doi: 10.1111/bju.70261. Epub 2026 Mar 27. PMID 41896701
- DERIVEDSushentsev N, Warren AY, Colling R, Verrill C, Pazukhina E, Blyuss O, Seibert TM, Barrett T, Mills IG, Bryant RJ, Donovan JL, Neal DE, Hamdy FC. Active Monitoring, Surgery, and Radiotherapy for Cribriform-Positive and Cribriform-Negative Prostate Cancer: A Secondary Analysis of the PROTECT Randomized Clinical Trial. JAMA Oncol. 2025 Dec 1;11(12):1512-1517. doi: 10.1001/jamaoncol.2025.4125. PMID 41100113
- DERIVEDDonovan JL, Hamdy FC, Lane JA, Young GJ, Metcalfe C, Walsh EI, Davis M, Steuart-Feilding T, Blazeby JM, Avery KNL, Martin RM, Bollina P, Doble A, Doherty A, Gillatt D, Gnanapragasam V, Hughes O, Kockelbergh R, Kynaston H, Paul A, Paez E, Powell P, Rosario DJ, Rowe E, Mason M, Catto JWF, Peters TJ, Wade J, Turner EL, Williams NJ, Oxley J, Staffurth J, Bryant RJ, Neal DE. Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment. NEJM Evid. 2023 Apr;2(4):EVIDoa2300018. doi: 10.1056/EVIDoa2300018. Epub 2023 Mar 11. PMID 38320051
- DERIVEDHamdy FC, Donovan JL, Lane JA, Metcalfe C, Davis M, Turner EL, Martin RM, Young GJ, Walsh EI, Bryant RJ, Bollina P, Doble A, Doherty A, Gillatt D, Gnanapragasam V, Hughes O, Kockelbergh R, Kynaston H, Paul A, Paez E, Powell P, Rosario DJ, Rowe E, Mason M, Catto JWF, Peters TJ, Oxley J, Williams NJ, Staffurth J, Neal DE; ProtecT Study Group. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2023 Apr 27;388(17):1547-1558. doi: 10.1056/NEJMoa2214122. Epub 2023 Mar 11.