Active Surveillance, Radical Prostatectomy, or Radiation Therapy in Treating Patients With Localized Prostate Cancer
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 surveillance to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.
Long-term Effects Secondary to Cancer Therapy in Adults
Drug: cyproterone acetate
Drug: releasing hormone agonist therapy
Other: active surveillance
Other: medical chart review
Other: questionnaire administration
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
Procedure: therapeutic lymphadenectomy
Radiation: 3-dimensional conformal radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Acitve Monitoring, Radical Prostatectomy, or Radiation Therapy in Treating Patients With Localized Prostate Cancer|
- Survival time as assessed after the first information appointment at 5 years,10 years, and then every 5 years thereafter [ Designated as safety issue: No ]
- Disease progression as assessed by PSA levels, digital rectal examination, ultrasonography, biopsy, and bone scans at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter [ Designated as safety issue: No ]
- Treatment complications as assessed at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter [ Designated as safety issue: Yes ]
- General health status as assessed by validated instruments, including the SF-12, a subset of the SF-36, and EuroQol EQ-5D at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter [ Designated as safety issue: No ]
- Anxiety, depression, and psychological state as assessed by the Hospital Anxiety and Depression Scale, the Profile of Moods States, and the Impact of Events scale at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter [ Designated as safety issue: No ]
- Urinary symptoms as assessed by the ICSmaleSF questionnaire and the UCLA prostate cancer index at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter [ Designated as safety issue: No ]
- Quality of life as assessed at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter [ Designated as safety issue: No ]
- Sexual function as assessed by the ICSsex questionnaire and the UCLA prostate cancer index at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter [ Designated as safety issue: No ]
- Quality of life related to prostate cancer treatment as assessed by the UCLA prostate cancer index at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter [ Designated as safety issue: No ]
- Qualitative evaluation of outcome as assessed by in-depth interviews with samples of patients in each arm of the trial and also the preference groups at 6 months, 1 year, 5 years, and 10 years and then every 5 years thereafter [ Designated as safety issue: No ]
- Resource use (NHS, social service, and personal) as assessed by routine hospital and primary care data sources with additional questions in clinical and participant questionnaires [ Designated as safety issue: No ]
|Study Start Date:||June 2001|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
- To assess survival of patients with localized prostate cancer at 10 years and 15 years after treatment.
- To investigate 5-year survival, disease progression (i.e., biochemical and clinical), treatment complications, and lower urinary tract symptoms in these patients.
- To investigate the psychosocial impact of case-finding and treatment on these patients, including generic health status, quality of life, and sexual function.
- To estimate the resource use and costs of case-finding, 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 (2-4 vs 5-7 vs 8-10), and average result of Prostate Check Clinic and first biopsy prostate-specific antigen (PSA) tests (< 6 vs 6-9.9 vs ≥ 10 ng/mL). Patients are either randomized to or select 1 of 3 treatment arms.
- Arm I (active monitoring): Patients undergo active monitoring of their disease. Patients are seen by the research nurse 3 months after randomization to fine disease management plan. As part of this process, patients, together with the urologist or research nurse, develop a management plan that includes repeat PSA testing (every 3 months in the first year and then every 6 months thereafter) to detect biochemical progression. Patients also undergo an annual review appointment with an opportunity for digital rectal examination, if indicated (e.g., rise in PSA or new symptoms). PSA levels are monitored and tests repeated as needed. Additional review appointment is arranged with the study urologist for confirmed rising PSA level, apparent symptoms of spreading disease, or concern about the PSA levels. At the review appointment, the study urologist discusses issues raised and current options, including remaining on active monitoring, undergoing re-staging of the cancer, or receiving other treatments, as appropriate.
- Arm II (radical prostatectomy): Patients undergo radical prostatectomy (RP) within 2-12 weeks after study entry. Patients undergo RP and pelvic lymphadenectomy with or without frozen section biopsy of the pelvic lymph nodes prior to prostatectomy. Patients with positive surgical margins may be recommended for adjuvant treatment at the surgeon's discretion.
- Arm III (radical conformal radiotherapy): Patients undergo 3-dimensional conformal radiotherapy for 7.4 weeks (37 fractions). Patients receive neoadjuvant androgen-deprivation therapy comprising luteinizing hormone-releasing hormone (LHRH) agonists once every 4 weeks, beginning prior to the start of radiotherapy and continuing for at least 3-6 months (at least until completion of radiotherapy). Patients also receive cyproterone acetate or equivalent alternative beginning 1 week prior to the first LHRH agonist injection and continuing for at least 3 weeks.
After completion of surgery or radiotherapy, patients are followed according to National Health Service (UK) guidelines every 6-12 months.
All patients complete questionnaires at baseline and periodically during study to provide socio-demographic information (e.g., age, socio-economic status, and ethnicity), as well as clinical information on past or current urinary symptoms, previous PSA tests, anxiety and depression, sexual function, general health status, treatment-related quality of life, and environmental exposures. Resource use and cost-utility analysis is also performed.
|Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust|
|Birmingham, England, United Kingdom, B15 2TH|
|Bristol, England, United Kingdom, BS10 5NB|
|Cambridge, England, United Kingdom, BC2 2QQ|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Leicester General Hospital|
|Leicester, England, United Kingdom, LE5 4PW|
|Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN|
|Oxford Radcliffe Hospital|
|Oxford, England, United Kingdom, 0X3 9DU|
|University of Sheffield School of Medicine and Biomedical Sciences|
|Sheffield, England, United Kingdom, S10 2TN|
|Edinburgh Cancer Centre at Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|University Hospital of Wales|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|Principal Investigator:||Freddie C. Hamdy, MD||Oxford Radcliffe Hospital|