|Phase III||Health services research, Treatment||Closed||50 to 69||Other||CDR0000584897|
SHEFF-PROTECT, ISRCTN20141297, EU-20802, SHEFF-HTA-96/20/99, RADCLIFFE-PROTECT, PROTECT, NCT00632983
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.
Further Study Information
- 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.
- Histologically confirmed prostate cancer
- Clinically localized disease
- Stage T1-T2, NX, M0 tumor
- Prostate-specific antigen (PSA) at the Prostate Check Clinic (PCC) in the range of 3.0-19.99 ng/mL
- No skeletal metastases by isotope bone scan (if PCC PSA 10-19.99 ng/mL or Gleason score 8-10)
- Registered with a participating general practice on the date of the PCC
- Registration with another practice after study entry allowed
- Life expectancy ≥ 10 years
- Fit for any of the three study treatments
- No concurrent or past malignancies other than a small treated skin cancer
- No serious cardiac or respiratory problems in the past 12 months, including any of the following:
- Myocardial infarction
- Heart failure
- Chronic obstructive pulmonary disease
- Blood-borne infections allowed
PRIOR CONCURRENT THERAPY:
- No prior treatment for prostate malignancy
- No prior kidney dialysis or transplantation
- No bilateral hip replacement
- No previous entry to this study at a prior general practice
Trial Lead Organizations/Sponsors
Oxford Radcliffe Hospital
|Freddie Charles Hamdy||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00632983
ClinicalTrials.gov processed this data on March 16, 2014
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