Prostate Cancer
Conditions
Keywords
Prostate cancer, Treatment, Screening, Surgery, Radiotherapy, Active monitoring
Brief summary
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.
Detailed 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.
Interventions
PROCEDURERadical prostatectomy
radical prostatectomy
RADIATIONConformal radiation therapy
Conformal radiation therapy, external beam
OTHERActive monitoring
Active monitoring of Prostate specific antigen levels and disease surveillance
Sponsors
University of Bristol
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 69 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease specific mortality | Median 15 years follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression | Median 15 years | Metastases |
| Treatment complications | Median 15 years | — |
| General health status | Median 15 years | — |
| Overall survival | Median 15 years | — |
| Symptoms | Median 15 years | — |
| Sexual function | Median 15years | — |
| Psychological state | Median 15 years | — |
Countries
United Kingdom
Outcome results
None listed