A phase III protocol of androgen suppression (AS) and 3DCRT/IMRT versus AS and 3DCRT/IMRT followed by chemotherapy (CT) with docetaxel and prednisone for localized, high-risk prostate cancer (RTOG 0521).

Genitourinary (Prostate) Cancer
Session Type and Session Title: 
Oral Abstract Session, Genitourinary (Prostate) Cancer
Abstract Number: 


J Clin Oncol 33, 2015 (suppl; abstr LBA5002)
Howard M. Sandler, Chen Hu, Seth A. Rosenthal, Oliver Sartor, Leonard G. Gomella, Mahul Amin, James Purdy, Jeff M. Michalski, Mark Garzotto, Nadeem Pervez, Alexander G. Balogh, George Rodrigues, Luis Souhami, M. Neil Reaume, Scott G. Williams, Raquibul Hannan, Eric M. Horwitz, Adam Raben, Rebecca Paulus, William U. Shipley; Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA; NRG Oncology Statistics and Data Management Center, Philadelphia, PA; Sutter Cancer Center, Sacramento, CA; Tulane University School of Medicine, New Orleans, LA; The Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA; Cedars-Sinai Medical Center, Los Angeles, CA; UC Davis, Sacramento, CA; Washington University in St. Louis, St. Louis, MO; Portland VAMC, Portland, OR; Cross Cancer Institute, Edmonton, AB, Canada; Tom Baker Cancer Center, Calgary, AB, Canada; Department of Radiation Oncology, London Regional Cancer Program, London, ON, Canada; Department of Radiation Oncology, McGill University Health Centre, Montreal, QC, Canada; Ottawa Hospital Cancer Center, Ottawa, ON, Canada; Peter MacCallum Cancer Centre, East Melbourne, Australia; The University of Texas Southwestern Medical Center, Dallas, TX; Fox Chase Cancer Center, Philadelphia, PA; Helen F Graham Cancer Ctr, Newark, DE; Radiation Therapy Oncology Group, Statistical Center, Philadelphia, PA; Massachusetts General Hospital, Harvard Medical School, Boston, MA

Abstract Disclosures


Background: High-risk, localized prostate cancer (PCa) patients have a relatively poor prognosis. We hypothesized that the addition of adjuvant docetaxel and prednisone to long-term (24 month) AS and radiation therapy (RT) would improve overall survival (OS). Methods: RTOG 0521 opened December 2005 and closed August 2009 with targeted accrual of 600 cases. It was designed to detect improvement in 4-year OS from 86% to 93% with a 51% hazard reduction (HR = 0.49). Under a 0.05 1-sided type I error and 90% power, at least 78 deaths were required to analyze the OS endpoint. Patients had 1) Gleason (Gl) 7-8, any T-stage, and PSA > 20, or 2) Gl 8, ≥ T2, any PSA, or 3) Gl 9-10, any T-stage, any PSA. All had PSA ≤ 150. RT dose was 75.6 Gy. CT consisted of 6, 21-day cycles of docetaxel + prednisone starting 28 days after RT. Results: Of 612 enrolled, 50 were excluded for eligibility issues, leaving 562 evaluable. Median age = 66, median PSA = 15.1, 53% had Gl 9-10, 27% had cT3-4. Median follow-up = 5.5 yrs. 4-yr OS rates were 89% [95% CI: 84-92%] for the AS+RT arm and 93% [95% CI: 90-96%] for the AS+RT+CT arm (1-sided p = 0.03, HR = 0.68 [95% CI: 0.44, 1.03]). There were 52 centrally-reviewed deaths in the AS+RT arm and 36 in the AS+RT+CT arm, with fewer deaths both due to PCa/treatment (20 vs 16) and due to other causes/unknown (32 vs 20) in the AS+RT+CT arm. 5-yr disease-free survival rates were 66% for AS+RT and 73% for AS+RT+CT (2-sided p = 0.05, HR = 0.76 [95% CI: 0.57, 1.00]). There was 1, Gr 5 unlikely-related adverse event (AE) in the AS+RT arm and 2, Gr 5 possibly/probably-related AEs with AS+RT+CT. Conclusions: For high-risk, localized PCa, adjuvant CT improved the OS from 89% to 93% at 4 years. Toxicity was acceptable. This trial was designed with a short OS assessment period and additional follow-up is warranted to determine the long-term benefit of CT to the current standard of care of long-term AS+RT. This project was supported by grants U10CA21661, U10CA180868, U10CA180822, from the National Cancer Institute and Sanofi with additional support from AstraZeneca for Australian site participation. Clinical trial information: NCT00288080