PMID- 14581419 OWN - NLM STAT- MEDLINE DCOM- 20031120 LR - 20220409 IS - 0732-183X (Print) IS - 0732-183X (Linking) VI - 21 IP - 21 DP - 2003 Nov 1 TI - Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. PG - 3972-8 AB - PURPOSE: Radiation Therapy Oncology Group (RTOG) Protocol 92-02 was a randomized trial testing long-term (LT) adjuvant androgen deprivation (AD) after initial AD with external-beam radiotherapy (RT) in patients with locally advanced prostate cancer (PC; T2c-4) and with prostate-specific antigen level less than 150 ng/mL. PATIENTS AND METHODS: Patients received a total of 4 months of goserelin and flutamide, 2 months before and 2 months during RT. A radiation dose of 65 to 70 Gy was given to the prostate and a dose of 44 to 50 Gy to the pelvic lymph nodes. Patients were randomly assigned to receive no additional therapy (short-term [ST]AD-RT) or 24 months of goserelin (LTAD-RT); 1,554 patients were entered onto the study. RESULTS: The LTAD-RT arm showed significant improvement in all efficacy end points except overall survival (OS; 80.0% v 78.5% at 5 years, P =.73), compared with the STAD-RT arm. In a subset of patients not part of the original study design, with tumors assigned Gleason scores of 8 to 10 by the contributing institutions, the LTAD-RT arm had significantly better OS (81.0% v 70.7%, P =.044). There was a small but significant increase in the frequency of late radiation grades 3, 4, and 5 gastrointestinal toxicity ascribed to the LTAD-RT arm (2.6% v 1.2% at 5 years, P =.037), the cause of which is not clear. CONCLUSION: The RTOG 92-02 trial supports the addition of LT adjuvant AD to STAD with RT for T2c-4 PC. In the exploratory subset analysis of patients with Gleason scores 8 to 10, LT adjuvant AD resulted in a survival advantage. FAU - Hanks, Gerald E AU - Hanks GE AD - Fox Chase Cancer Center and Radiation Therapy Oncology Group, Phialdelphia, PA 19107, USA. FAU - Pajak, Thomas F AU - Pajak TF FAU - Porter, Arthur AU - Porter A FAU - Grignon, David AU - Grignon D FAU - Brereton, Harmart AU - Brereton H FAU - Venkatesan, Varagur AU - Venkatesan V FAU - Horwitz, Eric M AU - Horwitz EM FAU - Lawton, Colleen AU - Lawton C FAU - Rosenthal, Seth A AU - Rosenthal SA FAU - Sandler, Howard M AU - Sandler HM FAU - Shipley, William U AU - Shipley WU CN - Radiation Therapy Oncology Group LA - eng GR - CA-21661/CA/NCI NIH HHS/United States GR - CA-32115/CA/NCI NIH HHS/United States PT - Clinical Trial PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, U.S. Gov't, P.H.S. PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Androgen Antagonists) RN - 0 (Antineoplastic Agents, Hormonal) RN - 0F65R8P09N (Goserelin) SB - IM EIN - J Clin Oncol. 2004 Jan 15;22(2):386 MH - Adenocarcinoma/*drug therapy/mortality/pathology/*radiotherapy MH - Adult MH - Aged MH - Aged, 80 and over MH - Androgen Antagonists/*administration & dosage MH - Antineoplastic Agents, Hormonal/*administration & dosage MH - Chemotherapy, Adjuvant MH - Combined Modality Therapy MH - Disease-Free Survival MH - Drug Administration Schedule MH - Goserelin/*administration & dosage MH - Humans MH - Male MH - Middle Aged MH - Neoplasm Staging MH - Prognosis MH - Prostatic Neoplasms/*drug therapy/mortality/pathology/*radiotherapy MH - Radiation Dosage MH - Survival Analysis MH - Treatment Outcome EDAT- 2003/10/29 05:00 MHDA- 2003/12/03 05:00 CRDT- 2003/10/29 05:00 PHST- 2003/10/29 05:00 [pubmed] PHST- 2003/12/03 05:00 [medline] PHST- 2003/10/29 05:00 [entrez] AID - JCO.2003.11.023 [pii] AID - 10.1200/JCO.2003.11.023 [doi] PST - ppublish SO - J Clin Oncol. 2003 Nov 1;21(21):3972-8. doi: 10.1200/JCO.2003.11.023.