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About
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.
Full description
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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
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:
Negative preoperative metastatic survey within 6 months prior to registration, including the following:
Bilateral lymph node dissection histologically negative for cancer
Nodal sampling not required with the following stage/biopsy specimen Gleason score/preoperative PSA:
Free from the following postoperative complications:
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:
Hepatic: SGOT no more than 2 x ULN
Other: No second malignancy within 5 years except adequately treated nonmelanomatous skin cancer
--Prior Concurrent Therapy--
Primary purpose
Allocation
Interventional model
Masking
408 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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