Prostate Testing for Cancer and Treatment (ProtecT)
|ClinicalTrials.gov Identifier: NCT02044172|
Recruitment Status : Active, not recruiting
First Posted : January 23, 2014
Last Update Posted : January 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: Radical prostatectomy Radiation: Conformal radiation therapy Other: Active monitoring||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer|
|Actual Study Start Date :||June 1, 2001|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Active Comparator: Radical prostatectomy
Procedure: Radical prostatectomy
Active Comparator: Conformal radiation therapy
Conformal radiation therapy External beam radiation therapy
Radiation: Conformal radiation therapy
Conformal radiation therapy, external beam
Active Comparator: Active monitoring
Active monitoring of prostate specific antigen levels and disease surveillance
Other: Active monitoring
Active monitoring of Prostate specific antigen levels and disease surveillance
- Disease specific mortality [ Time Frame: Median 10 years follow up ]
- Overall survival [ Time Frame: Median 10 years ]
- Disease progression [ Time Frame: Median 10 years ]Metastases
- Treatment complications [ Time Frame: Median 10 years ]
- General health status [ Time Frame: Median 10 years ]
- Psychological state [ Time Frame: Median 10 years ]
- Symptoms [ Time Frame: Median 10 years ]
- Sexual function [ Time Frame: Median 10 years ]
- Resource use [ Time Frame: Median 10 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044172
|Queen Elizabeth Hospital|
|Birmingham, United Kingdom|
|Bristol, United Kingdom|
|Cambridge, United Kingdom|
|University Hospital of Wales|
|Cardiff, United Kingdom|
|Western General Hospital|
|Edinburgh, United Kingdom|
|Leicester General Hospital|
|Leicester, United Kingdom|
|Newcastle, United Kingdom|
|Royal Hallamshire Hospital|
|Sheffield, United Kingdom|
|Principal Investigator:||Freddie C Hamdy||University of Oxford|