Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer
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.
Procedure: adjuvant therapy
Radiation: 3-dimensional conformal radiation therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized, Multicenter Study Comparing the Immediate Adjuvant Radiotherapy Associate With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) vs Delayed Radiotherapy Until Biochemical Relapse Associated With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) in Patients With Operable Prostate Cancer pT3 R1 pN0 or pNx at Intermediate Risk.|
- Event-free survival (clinical progression, biochemical progression, death) at 5 years [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Metastases-free survival [ Designated as safety issue: No ]
- Acute or chronic toxicity [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
- Functional dependence in patients over 75 years old [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Estimated Primary Completion Date:||December 2022 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667069
|Bordeaux, France, 33076|
|Contact: Contact Person 33-5-5633-3320|
|Hopital Saint Andre||Recruiting|
|Bordeaux, France, 33075|
|Contact: Contact Person 33-5-5679-5808|
|Centre Regional Francois Baclesse||Recruiting|
|Caen, France, 14076|
|Contact: Contact Person 33-2-3145-5000|
|Hopitaux Civils de Colmar||Recruiting|
|Colmar, France, 68024|
|Contact: Contact Person 33-3-8912-4000|
|Centre Hospitalier Universitaire Henri Mondor||Recruiting|
|Creteil, France, 94000|
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|Centre Leon Berard||Recruiting|
|Lyon, France, 69373|
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|Clinique du Pont de Chaume||Recruiting|
|Montauban, France, 82017|
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|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle||Recruiting|
|Montpellier, France, 34298|
|Contact: Contact Person 33-4-6761-3100|
|Centre Regional Rene Gauducheau||Recruiting|
|Nantes-Saint Herblain, France, 44805|
|Contact: Contact Person 33-2-40-479-959|
|Hopital Europeen Georges Pompidou||Recruiting|
|Paris, France, 75015|
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|Centre Hospitalier Lyon Sud||Recruiting|
|Pierre Benite, France, 69495|
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|Poitiers, France, 86021|
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|Centre Henri Becquerel||Recruiting|
|Rouen, France, 76038|
|Contact: Contact Person 33-2-3208-2222|
|Institut de Cancerologie de la Loire||Recruiting|
|Saint Priest en Jarez, France, 42270|
|Contact: Contact Person 33-477-91-7000|
|Institut Claudius Regaud||Recruiting|
|Toulouse, France, 31052|
|Contact: Contact Person 33-5-6142-4242|
|Centre Alexis Vautrin||Recruiting|
|Vandoeuvre-les-Nancy, France, 54511|
|Contact: Contact Person 33-3-8359-8400|
|Institut Gustave Roussy||Recruiting|
|Villejuif, France, F-94805|
|Contact: Contact Person 33-1-4211-4339|
|Study Chair:||Pierre Richaud, MD||Institut Bergonié|