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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
Alternate Title 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. 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 Prior/Concurrent Therapy: Biologic therapy: Not specified 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 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 Renal: Not specified Other: No second malignancy within 5 years except adequately treated nonmelanomatous skin cancer Expected Enrollment 408 eligible patients will be entered over about 8.5 years. 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.Published Results Moinpour CM, Hayden KA, Unger JM, et al.: Health-related quality of life results in pathologic stage C prostate cancer from a Southwest Oncology Group trial comparing radical prostatectomy alone with radical prostatectomy plus radiation therapy. J Clin Oncol 26 (1): 112-20, 2008.[PUBMED Abstract] Swanson GP, Goldman B, Tangen CM, et al.: The Prognostic Impact of Seminal Vesicle Involvement Found at Prostatectomy and the Effects of Adjuvant Radiation: Data From Southwest Oncology Group 8794. J Urol : , 2008.[PUBMED Abstract] Swanson GP, Hussey MA, Tangen CM, et al.: Predominant treatment failure in postprostatectomy patients is local: analysis of patterns of treatment failure in SWOG 8794. J Clin Oncol 25 (16): 2225-9, 2007.[PUBMED Abstract] Swanson GP, Hussey MA, Thompson IM, et al.: Pre radiation PSA predicts for outcome of adjuvant radiation in SWOG 8794. [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA A-668, 2006. Thompson IM Jr, Tangen CM, Paradelo J, et al.: Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA 296 (19): 2329-35, 2006.[PUBMED Abstract] Swanson GP, Thompson IM, Tangem C, et al.: Phase III randomized study of adjuvant radiation therapy versus observation in patients with pathologic T3 prostate cancer (SWOG 8794). [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-1, S1, 2005. Related PublicationsGanswindt U, Stenzl A, Bamberg M, et al.: Adjuvant Radiotherapy for Patients with Locally Advanced Prostate Cancer-A New Standard? Eur Urol : , 2008.[PUBMED Abstract] Thompson IM, Paradelo JC, Crawford ED, et al.: An opportunity to determine optimal treatment of pT3 prostate cancer: the window may be closing. Urology 44 (6): 804-11, 1994.[PUBMED Abstract] Trial Lead Organizations Southwest Oncology Group
Eastern Cooperative Oncology Group
NCIC-Clinical Trials Group
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Cancer and Leukemia Group B
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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