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

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.

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