Trial Information

Acitve Monitoring, 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 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.