NCT02044172: ProtecT

Prostate Testing for Cancer and Treatment

Active, enrolled NA Last updated 14 November 2022

What this trial tests

NA trial testing Radical prostatectomy in Prostate Cancer in 82,849 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 June 2001

Primary endpoint
14 November 2020

31 March 2027

Quick facts

Lead sponsor	University of Oxford
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	82,849
Start date	1 June 2001
Primary completion	14 November 2020
Estimated completion	31 March 2027
Sites	8 locations across United Kingdom

Drugs / interventions tested

• Radical prostatectomy
• Conformal radiation therapy
• Active monitoring

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

University of Oxford

Who can join

Adults 50 to 69, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer.
   Hamdy FC, Donovan JL, Lane JA, Mason M, et al · · 2016 · cited 1761× · PMID 27626136 · DOI 10.1056/nejmoa1606220
2. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.
   Donovan JL, Hamdy FC, Lane JA, Mason M, et al · · 2016 · cited 899× · PMID 27626365 · DOI 10.1056/nejmoa1606221
3. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.
   Hamdy FC, Donovan JL, Lane JA, Metcalfe C, et al · · 2023 · cited 576× · PMID 36912538 · DOI 10.1056/nejmoa2214122
4. Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial.
   Lane JA, Donovan JL, Davis M, Walsh E, et al · · 2014 · cited 161× · PMID 25163905 · DOI 10.1016/s1470-2045(14)70361-4
5. Prevalence of the HOXB13 G84E germline mutation in British men and correlation with prostate cancer risk, tumour characteristics and clinical outcomes.
   Kote-Jarai Z, Mikropoulos C, Leongamornlert DA, Dadaev T, et al · · 2015 · cited 76× · PMID 25595936 · DOI 10.1093/annonc/mdv004
6. Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment.
   Donovan JL, Hamdy FC, Lane JA, Young GJ, et al · · 2023 · cited 68× · PMID 38320051 · DOI 10.1056/evidoa2300018
7. Functional and quality of life outcomes of localised prostate cancer treatments (Prostate Testing for Cancer and Treatment [ProtecT] study).
   Lane JA, Donovan JL, Young GJ, Davis M, et al · · 2022 · cited 57× · PMID 35373443 · DOI 10.1111/bju.15739
8. Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life.
   Lane A, Metcalfe C, Young GJ, Peters TJ, et al · · 2016 · cited 44× · PMID 27415448 · DOI 10.1111/bju.13582