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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82,849
radical prostatectomy
Conformal radiation therapy, external beam
Active monitoring of Prostate specific antigen levels and disease surveillance
Queen Elizabeth Hospital
Birmingham, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Addenbrokes' Hospital
Cambridge, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Disease specific mortality
Time frame: Median 15 years follow up
Overall survival
Time frame: Median 15 years
Disease progression
Metastases
Time frame: Median 15 years
Treatment complications
Time frame: Median 15 years
General health status
Time frame: Median 15 years
Psychological state
Time frame: Median 15 years
Symptoms
Time frame: Median 15 years
Sexual function
Time frame: Median 15years
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Western General Hospital
Edinburgh, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom