Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer.

Detailed Description
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OBJECTIVES: Compare the impact of neoadjuvant androgen blockade therapy comprising triptorelin and flutamide followed by conformal external beam radiotherapy and continued androgen blockage therapy vs conformal external beam radiotherapy alone in patients with stage II or III prostate cancer. Compare the survival rate, in terms of 5-year clinical or biological remission, in patients treated with these regimens. Compare overall survival in patients treated with these regimens. Compare acute and late toxicity of these regimens in these patients. Compare quality of life of patients treated with these regimens. Determine the value and time-delay to obtain prostate-specific antigen nadir in patients treated with external beam radiotherapy alone. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo conformal external beam radiotherapy. Arm II: Patients receive androgen blockade therapy comprising triptorelin subcutaneously every 4 weeks and oral flutamide once daily. Androgen blockade therapy continues for a total of 4 months. Two months after initiation of androgen blockade therapy, patients undergo conformal external beam radiotherapy. Quality of life is assessed. PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Official Title
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Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: flutamide
* Drug: triptorelin
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer, meeting the following clinical staging criteria: Stage T1b-T1c AND prostate specific antigen (PSA) ≥ 10 ng/mL OR Stage T1b-T1c AND Gleason score ≥ 7 OR Stage T2a-T3a No lymph node invasion (N0 or N-) Patients with ≥ 10% risk by the Partin table must undergo curage No metastatic disease (M0) by thoracic radiography and bone scan PSA < 30 ng/mL No history of invasive cancer PATIENT CHARACTERISTICS: Age Under 75 Performance status ECOG 0-1 Life expectancy At least 10 years Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy No prior hormonal therapy Radiotherapy No prior pelvic radiotherapy Surgery No prior radical prostatectomy No prior castration

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: radiotherapy alone<br> | Radiation: radiation therapy<br> <br> |
| Experimental: Radiotherapy + androgene deprivation<br> | Drug: flutamide<br> <br> Drug: triptorelin<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of complete androgen blockade for 4 months |  |  | 
| Survival, in terms of clinical or biological remission, at 5 years |  |  | 
| Overall survival |  |  | 
| Acute and late toxicity |  |  | 
| Quality of life |  |  | 
| Value and time-delay to obtain prostate-specific antigen nadir (for patients undergoing external beam radiotherapy alone) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer