This trial is active, not recruiting.

Condition prostate cancer
Treatments radical prostatectomy, conformal radiation therapy, active monitoring
Phase phase 3
Sponsor University of Oxford
Collaborator University of Bristol
Start date June 2001
End date December 2015
Trial size 100000 participants
Trial identifier NCT02044172, 20141297, HTA96/20/99


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Radical prostatectomy
radical prostatectomy
radical prostatectomy
(Active Comparator)
Conformal radiation therapy External beam radiation therapy
conformal radiation therapy
Conformal radiation therapy, external beam
(Active Comparator)
Active monitoring of prostate specific antigen levels and disease surveillance
active monitoring
Active monitoring of Prostate specific antigen levels and disease surveillance

Primary Outcomes

Disease specific mortality
time frame: Median 10 years follow up

Secondary Outcomes

Overall survival
time frame: Median 10 years
Disease progression
time frame: Median 10 years
Treatment complications
time frame: Median 10 years
General health status
time frame: Median 10 years
Psychological state
time frame: Median 10 years
time frame: Median 10 years
Sexual function
time frame: Median 10 years
Resource use
time frame: Median 10 years

Eligibility Criteria

Male participants from 50 years up to 69 years old.

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.

Additional Information

Official title The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer
Principal investigator Freddie C Hamdy
Description OBJECTIVES: - To assess survival of patients with localized prostate cancer at 10 years and 15 years after treatment. - To investigate disease progression (i.e., biochemical and clinical), treatment complications, and lower urinary tract symptoms in these patients. - To investigate the psychosocial impact of cancer detection and treatment on these patients, including generic health status, quality of life, and sexual function. - To estimate the resource use and costs of detection, treatment, and follow-up. - To compare costs and outcomes of treatment in terms of survival and health-related quality of life. - To collect samples suitable for basic science research (ProMPT study). OUTLINE: This is a multicenter study. Patients are stratified by age (50-55 vs 56-59 vs 60-65 vs 66-69 years), Gleason score (6, 7, 8-10), and average result of recruitment and first biopsy prostate-specific antigen (PSA) tests (< 6 vs 6-9.9 vs ≥ 10 ng/mL). Patients are randomized or select a treatment to be followed up in a cohort study.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Oxford.