Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00667069|
Recruitment Status : Active, not recruiting
First Posted : April 25, 2008
Last Update Posted : May 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: triptorelin Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||718 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||April 2008|
|Estimated Primary Completion Date :||April 2022|
- Event-free survival (clinical progression, biochemical progression, death) at 5 years
- Overall survival
- Metastases-free survival
- Acute or chronic toxicity
- Quality of life
- Functional dependence in patients over 75 years old
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667069
|Study Chair:||Pierre Richaud, MD||Institut Bergonié|