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Phase III Randomized Study of Whole-Pelvic Irradiation Followed by a Cone-Down Boost to the Prostate vs Prostate Irradiation Only and of Neoadjuvant vs Adjuvant FLUT/ZDX for Adenocarcinoma of the Prostate
Alternate Title Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer
Objectives I. Examine whether total androgen suppression (TAS) with flutamide/goserelin and whole-pelvic irradiation followed by a cone-down boost to the prostate improves progression-free survival at 5 years by at least 10% compared to TAS and prostate-only irradiation in patients with adenocarcinoma of the prostate at significant risk of nodal involvement. II. Examine whether induction and concurrent (neoadjuvant) TAS and radiotherapy improves the progression-free survival at 5 years by at least 10% compared to adjuvant TAS and radiotherapy. III. Compare treatments with regard to local control, time to distant failure, and overall survival. Entry Criteria Disease Characteristics: Histologically confirmed adenocarcinoma of the prostate Any stage with an estimated risk of node involvement at least 15% (and therefore at significant risk for local and/or systemic failure) based on pretreatment PSA and Gleason score (GS), e.g.: GS of 7 and PSA greater than 7.5 ng/mL GS of 6 and PSA greater than 22.5 ng/mL GS of 5 and PSA greater than 37.5 ng/mL PSA greater than 4 and less than 100 ng/mL Highest pretreatment value determined by a monoclonal assay that has a normal range of 0-4 ng/mL PSA measured by polyclonal assay (e.g., Yang) that has a normal range of 0-2.5 ng/mL may need to be divided by a conversion factor of approximately 1.5 GS determination required prior to entry No distant metastases No biopsy proven lymph node involvement Ineligible for protocol RTOG-9408 (clinical stages T2c-T4 with GS of 6 or higher are eligible for this study) Prior/Concurrent Therapy: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: At least 90 days since testosterone At least 60 days since finasteride Radiotherapy: No prior radiotherapy Surgery: No more than 60 days since surgical staging No radical surgery or cryosurgery Patient Characteristics: Age: Any age Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Liver function tests no greater than 1.2 times normal Renal: Not specified Other: No major medical or psychiatric illness that would prevent completion of treatment or interfere with follow-up No second malignancy within 5 years except superficial nonmelanomatous skin cancer Expected Enrollment 1,200 patients will be accrued over 2.5 years. Outline Randomized study. Arm I: Neoadjuvant Antiandrogen Therapy with Radiotherapy. Flutamide, FLUT, NSC-147834; Goserelin, Zoladex, ZDX, NSC-606864; with irradiation of the whole pelvis followed by a boost to the prostate using photons of at least 6 MV. Arm II: Neoadjuvant Antiandrogen Therapy with Radiotherapy; FLUT; ZDX; with irradiation of the prostate using equipment as in Arm I. Arm III: Radiotherapy followed by Adjuvant Antiandrogen Therapy. Irradiation as in Arm I; followed by FLUT; ZDX. Arm IV: Radiotherapy followed by Adjuvant Antiandrogen Therapy. Irradiation as in Arm II; followed by FLUT; ZDX.Published Results Speight JL: An update of the Phase III trial comparing whole pelvic to prostate only radiotherapy and neoadjuvant to adjuvant total androgen suppression: Updated analysis of RTOG 94-13 with emphasis on unexpected hormone/radiation interactions Lawton CA, DeSilvio M, Roach M III, Uhl V, Kirsch R, Seider M, Rotman M, Jones C, Asbell S, Valicenti R, Hahn S, Thomas CR Jr., Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI. Urol Oncol 26 (4): 446-7, 2008. Taussky D, Bae K, Bahary JP, et al.: Does Timing of Androgen Deprivation Influence Radiation-Induced Toxicity? A Secondary Analysis of Radiation Therapy Oncology Group Protocol 9413. Urology : , 2008.[PUBMED Abstract] Lawton CA, DeSilvio M, Roach M 3rd, et al.: An update of the phase III trial comparing whole pelvic to prostate only radiotherapy and neoadjuvant to adjuvant total androgen suppression: updated analysis of RTOG 94-13, with emphasis on unexpected hormone/radiation interactions. Int J Radiat Oncol Biol Phys 69 (3): 646-55, 2007.[PUBMED Abstract] Bahary J, Bae K, Taussky D, et al.: Does timing of androgen deprivation influence radiation-induced toxicity? A secondary analysis of Radiation Therapy Oncology Group protocol 9413. [Abstract] J Clin Oncol 24 (Suppl 18): A-4655, 2006. Roach M 3rd, DeSilvio M, Valicenti R, et al.: Whole-pelvis, "mini-pelvis," or prostate-only external beam radiotherapy after neoadjuvant and concurrent hormonal therapy in patients treated in the Radiation Therapy Oncology Group 9413 trial. Int J Radiat Oncol Biol Phys 66 (3): 647-53, 2006.[PUBMED Abstract] Taussky D, Bae K, Bahary J, et al.: Does testosterone influence radiation-induced toxicity In radiotherapy of the prostate? A secondary analysis of RTOG protocol 9413. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2215, S329-30. Lawton CA, DeSilvio M, Roach M, et al.: An update of the phase III trial comparing whole-pelvic (WP) to prostate only (PO) radiotherapy and neoadjuvant to adjuvant total androgen suppression (TAS): updated analysis of RTOG 94-13. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-32, S19, 2005. Roach M, DeSilvio M, Thomas C Jr, et al.: Field size and progression free survival (PFS) after neoadjuvant hormonal therapy (HT) and radiotherapy (RT) for prostate cancer: secondary analysis of RTOG 9413. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-87, 2005. Roach M, DeSilvio M, Thomas CR, et al.: Progression free survival (PFS) after whole-pelvic (WP) vs. mini-pelvic (MP) or prostate only (PO) radiotherapy (RT): a subset analysis of RTOG 9413, a phase III prospective randomized using neoadjuvant and concurrent (N&CHT). [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-1014, S264, 2004. Roach M 3rd, DeSilvio M, Lawton C, et al.: Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol 21 (10): 1904-11, 2003.[PUBMED Abstract] Roach M III, DeSilvio M, Lawton C, et al.: Neoadjuvant hormonal therapy (NHT) with whole-pelvic (WP) radiotherapy (RT) improves progression-free survival (PFS): RTOG (Radiation Therapy Oncology Group) 9413, a phase III randomized trial. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-711, 2002. Roach M III, Lu JD, Lawton C, et al.: A phase III trial comparing whole-pelvic (WP) to prostate only (PO) radiotherapy and neoadjuvant to adjuvant total androgen suppression (TAS): preliminary analysis of RTOG 9413. [Abstract] Int J Radiat Oncol Biol Phys 51 (3 suppl 1): Plenary A-5, 3, 2001. Related PublicationsMillar J, Boyd R, Sutherland J: An update of the phase III trial comparing whole pelvic to prostate only radiotherapy and neoadjuvant to adjuvant total androgen suppression: updated analysis of RTOG 94-13, with emphasis on unexpected hormone/radiation interactions: in regard to Lawton et al. (Int J Radiat Oncol Biol Phys 2007;69:646-655.). Int J Radiat Oncol Biol Phys 71 (1): 316; author reply 316, 2008.[PUBMED Abstract] Williams S, Wiltshire K: Updated analysis of RTOG 94-13: in regard to Lawton et al. (Int J Radiat Oncol Biol Phys 2007;69:646-655). Int J Radiat Oncol Biol Phys 71 (1): 315; author reply 315-6, 2008.[PUBMED Abstract] Paner GP, Bae K, Grignon DJ, et al.: Trends in Gleason grading of prostate cancer (PCa): analysis of reporting by institutional and central review pathologists in four Radiation Therapy Oncology Group (RTOG) protocols spanning 17 years and 2094 needle biopsies (bxs). [Abstract] United States and Canadian Academy of Pathology 96th Annual Meeting, March 24-30, 2007, San Diego, CA. A-766, 2007. Pan CC, Bae K, Hanks GE, et al.: Comparison of two types of biochemical failures within the ASTRO and Phoenix Consensus definitions in patients treated on RTOG 92–02 and 94–13. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2196, S318, 2006. Roach M, Moughan J, Movsas B, et al.: Socio-demographic predictors of biochemical failure and survival among high risk patients treated on Radiation Therapy Oncology Group (RTOG) prostate cancer trials: a meta-analysis. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1127, S204, 2006. Ganswindt U, Paulsen F, Corvin S, et al.: Intensity modulated radiotherapy for high risk prostate cancer based on sentinel node SPECT imaging for target volume definition. BMC Cancer 5: 91, 2005.[PUBMED Abstract] Roach M 3rd: The role of PSA in the radiotherapy of prostate cancer. Oncology (Huntingt) 10 (8): 1143-53; discussion 1154-61, 1996.[PUBMED Abstract] Trial Lead Organizations Radiation Therapy Oncology Group
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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