Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
OBJECTIVES:
- 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.
After surgery, patients are followed periodically according to institutional guidelines at 6-12 months and then annually thereafter.
- 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 radiotherapy, patients are followed at 1 month, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter until disease progression.
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.
Purpose
