Radiation Therapy After Prostatectomy in Treating Patients With Stage III Prostate Cancer

Study Overview
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Brief Summary
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Randomized phase III trial to compare treatment with or without adjuvant radiation therapy in men with stage III prostate cancer who have had radical prostatectomy and lymphadenectomy recently. Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.

Detailed Description
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OBJECTIVES: I. Compare disease-free survival rates of patients randomly assigned to adjuvant external-beam radiotherapy vs. no adjuvant therapy following radical prostatectomy and pelvic lymphadenectomy for surgical Stage C (T3 N0 M0) adenocarcinoma of the prostate. II. Determine the qualitative and quantitative toxicities associated with this adjuvant therapy. OUTLINE: Randomized study. Randomization takes place when the patient is physically able to begin treatment, any time within 16 weeks after surgery. Arm I: Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV. Arm II: No further treatment.

Official Title
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Phase III Randomized Evaluation of Adjuvant Radiotherapy vs No Adjuvant Therapy Following Radical Prostatectomy and Pelvic Lymphadenectomy in Surgical Stage C Adenocarcinoma of the Prostate

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: low-LET photon therapy


Participation Criteria
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Eligibility Criteria
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PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Pathologically documented Stage C (T3 N0 M0) adenocarcinoma of the prostate following radical prostatectomy and pelvic lymphadenectomy for clinical Stage A/B disease Ineligible for SWOG protocols of higher priority At least 1 of the following on pathologic examination: Presence of cancer in the seminal vesicles Evidence of cancer at the inked surgical margin of the prostate Extension of tumor beyond the prostatic capsule Negative preoperative metastatic survey within 6 months prior to registration, including the following: Normal bone scan No palpable evidence of extraprostatic tumor extension Bilateral lymph node dissection histologically negative for cancer Nodal sampling not required with the following stage/biopsy specimen Gleason score/preoperative PSA: Stage T1a/2-6/<10 ng/ml Stage T1b-c/2-5/<10 ng/ml Stage T2a/2-6/<10 ng/ml Stage T2b/2-6/<6 ng/ml Stage T2c/2-6/<4 ng/ml Free from the following postoperative complications: Total urinary incontinence Intraoperative rectal injury persistent urinary extravasation Pelvic infection Concurrent registration on protocol SWOG-9205 (serum repository protocol) optional Concurrent registration on protocol SWOG-8994 (quality-of-life study) required of English-speaking and Spanish-speaking patients enrolled by SWOG --Patient Characteristics-- Age: Any age Performance status: SWOG 0-2 Life expectancy: At least 2 years Hematopoietic: WBC at least institutional LLN Platelets at least institutional LLN Hepatic: SGOT no more than 2 x ULN Other: No second malignancy within 5 years except adequately treated nonmelanomatous skin cancer --Prior Concurrent Therapy-- Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: No more than 3 months of hormonal therapy prior to prostatectomy allowed Radiotherapy: No prior radiotherapy for prostate cancer Surgery: Radical prostatectomy and pelvic lymphadenectomy within 16 weeks prior to registration required

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Experimental: Arm I<br>Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV. | Procedure: low-LET photon therapy<br> <br> |
| No Intervention: Arm II<br>No further treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |