Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.

Detailed Description
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OBJECTIVES: Primary Compare the efficacy of adjuvant radiotherapy with vs without concurrent goserelin, in terms of biological and/or clinical progression-free survival, in patients who have undergone surgery for recurrent or refractory prostate cancer. Secondary Compare overall survival of patients treated with these regimens. Compare metastases-free survival of patients treated with these regimens. Compare the immediate and delayed toxicities of these regimens. Compare the delay in reaching the prostate-specific antigen nadir in patients treated with these regimens. Compare the quality of life at 1 and 5 years after radiotherapy in these patients. Compare the functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over. OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo radiotherapy once daily, 5 days a week, for 7 weeks. Arm II: Patients undergo radiotherapy as in arm I. Patients also receive goserelin subcutaneously on day 1 and again 3 months later. Quality of life is assessed periodically. After completion of study therapy, patients are followed periodically for 10 years. PROJECTED ACCRUAL: A total of 466 patients will be accrued for this study.

Official Title
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Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: goserelin acetate
* Procedure: adjuvant therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Localized disease treated with surgery only pT2, pT3, or pT4 pN0 or pNx No clinical signs of progressive disease Prostate-specific antigen (PSA) meeting the following criteria: PSA ≤ 0.1 ng/mL after prostatectomy PSA ≥ 0.2 ng/mL and < 2 ng/mL at study entry PATIENT CHARACTERISTICS: ECOG performance status 0-1 Life expectancy ≥ 10 years No other cancer in the past 5 years except for treated basal cell skin cancer No known pituitary gland adenoma No uncontrolled hypertension (i.e., blood pressure ≥ 160 mm Hg systolic and/or 90 mm Hg diastolic) No geographical, social, or psychological condition that would preclude study treatment PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior hormonal therapy No prior pelvic radiotherapy No prior surgical or chemical castration At least 6 months since surgery for biological recurrence No other concurrent anticancer therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: I<br>Exclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer | Procedure: adjuvant therapy<br> <br> Radiation: radiation therapy<br> <br> |
| Experimental: II<br>Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer | Drug: goserelin acetate<br> <br> * Other names: ZOLADEX;Procedure: adjuvant therapy<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 |
| --- | --- | --- |
| Progression-free (biological and/or clinical) survival |  | 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | not yet evaluable | 
| Metastases-free survival |  | not yet evaluable | 
| Immediate and delayed toxicities |  | not yet evaluable | 
| Delay in reaching the prostate-specific antigen nadir |  | not yet evaluable | 
| Quality of life at 1 and 5 years after radiotherapy |  | not yet evaluable | 
| Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over |  | not yet evaluable | 

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