Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00667069
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the efficacy, in terms of event-free survival at 5 years, of immediate radio-hormonal therapy immediately after prostatectomy for tumor pT2, R1, pN0, or pNx versus radio-hormonal therapy at biochemical relapse.
Secondary
* Compare the overall survival of patients treated with these regimens.
* Compare the metastasis-free survival of these patients.
* Compare the acute and late toxicities of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Compare the functional dependence of patients over 75 years old.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
* Arm I (delayed treatment): Patients receive triptorelin intramuscularly on day 1 and then 3 months later. Patients also undergo conformal radiotherapy daily, 5 days a week, for 7 weeks. Treatment begins at biochemical relapse (PSA is more than 0.2 ng/mL) and before PSA is more than 2 ng/mL.
* Arm II (immediate treatment): Patients receive treatment as in arm I, but treatment begins within 6 months after surgery.
After completion of study treatment, patients are followed for up to 5 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 424
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Immediate treatment adjuvant therapy Radiotherapy and Hormonotherapy at randomization A Relapse triptorelin Radiotherapy and Hormonotherapy only if relapse A Relapse 3-dimensional conformal radiation therapy Radiotherapy and Hormonotherapy only if relapse B Immediate treatment triptorelin Radiotherapy and Hormonotherapy at randomization B Immediate treatment 3-dimensional conformal radiation therapy Radiotherapy and Hormonotherapy at randomization A Relapse adjuvant therapy Radiotherapy and Hormonotherapy only if relapse
- Primary Outcome Measures
Name Time Method Event-free survival From randomization to disease progression or death, up to 5 years The event-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (clinical progression, biochemical progression, death)
- Secondary Outcome Measures
Name Time Method Acute or chronic toxicity Throughout study completion, up to 10 years The National Cancer Institute-Common Terminology Criteria for Adverse Events version 3 (NCI-CTCAE v3.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale will assess the severity of sensory neuropathic disorders, this derivative into 5 grades determined by the investigator.
Quality of life questionnaire - Core 30 (QLQ-C30) At baseline, 2 years, and 5 years Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.Overall survival From randomization to death from any cause, up to 10 years The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Metastases-free survival From randomization to metastases onset, up to 10 years The metastases-free survival is the length of time during and after the treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body.
Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25) At baseline, 2 years, and 5 years This EORTC prostate cancer specific questionnaire is intended to supplement the QLQ-C30.
The prostate cancer module is a 25-item questionnaire designed for use among patients with localized and metastatic prostate cancer. It includes subscales assessing urinary symptoms (9 items), bowel symptoms (4 items), treatment-related symptoms (6 items), and sexual functioning (6 items). Using a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), patients indicate the degree to which they have experienced symptoms.Functional dependence in patients over 75 years old At baseline, 2 years, and 5 years The Lawton Instrumental Activities of Daily Living (IADL) Scale is a self-reported questionnaire to assess independent living skills for older adults. This questionnaire, composed of 31 questions organized into 8 domains (ability to use telephone, shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications, and ability to handle finances), is designed to identify improvement or deterioration of a person functioning over time. Each domain is scored 0-1 for a summary score ranging from 0 (low function, dependent) to 8 (high function, independent).
Trial Locations
- Locations (17)
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Creteil, France
Clinique du Pont de Chaume
🇫🇷Montauban, France
Centre Henri Becquerel
🇫🇷Rouen, France
Institut de Cancerologie de la Loire
🇫🇷Saint Priest en Jarez, France
Hopitaux Civils de Colmar
🇫🇷Colmar, France
Hopital Saint Andre
🇫🇷Bordeaux, France
Centre Leon Berard
🇫🇷Lyon, France
Centre Regional Rene Gauducheau
🇫🇷Saint-Herblain, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Institut Bergonie
🇫🇷Bordeaux, France
CHU Poitiers
🇫🇷Poitiers, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France