Abstract
Combined androgen deprivation therapy (ADT) and radiotherapy (RT) improves outcomes for intermediate and high-risk prostate cancer. Treatment intensification with abiraterone acetate/prednisone (AAP) provides additional benefit for high-risk disease. We previously reported 3-year outcomes of a single-arm prospective multicenter trial (AbiRT trial) of 33 patients with unfavorable intermediate risk (UIR) and favorable high risk (FHR) prostate cancer undergoing short course, combination therapy with ADT, AAP, and RT. Here we report the final analysis demonstrating a high rate of testosterone recovery (97%) and excellent biochemical progression-free survival (97%) at 5 years. These data support comparative prospective studies of shorter, more potent ADT courses in favorable high-risk prostate cancer.
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The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Acknowledgements
The study was conducted within the US Department of Defense (DOD) Prostate Cancer Clinical Trials Consortium with institutional review board approval through participating sites: Duke Cancer Institute and MD Anderson Cancer Center (ClinicalTrials.gov NCT01717053). This work was supported by funding from Janssen Scientific Affairs. The infrastructure to complete this trial was supported by the 2 consecutive Department of Defense Congressionally Directed Medical Research Program (DOD CDMRP) Prostate Cancer Clinical Trials Consortium grants: W81XWH-09-1-0152 and W81XWH-14-2-0198.
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Contributions
REF: data interpretation, manuscript writing and editing. BFK: trial design, data interpretation, trial enrollment, manuscript editing. KEH: data interpretation, trial enrollment, manuscript editing. SH: statistical analysis, data interpretation, manuscript editing. LEH: statistical analysis, data interpretation, manuscript editing. MA: statistical analysis, data interpretation. DJG: trial design, data interpretation, trial enrollment. TZ: trial design, data interpretation, trial enrollment. WRB: trial design, trial enrollment. WRL: data interpretation, trial enrollment, manuscript editing. MRH: data interpretation, trial enrollment. PGC: data interpretation, trial enrollment. AJA: trial design, data interpretation, trial enrollment, manuscript writing and editing.
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Competing interests
REF has received consulting fees from Decipher Biosciences, Eisai, Seagen/Pfizer, and participated in advisory boards for Telix. BFK received research funding (to Duke) from Janssen Scientific Affairs for this work. She also has served on advisory boards for Blue Earth Diagnostics, Myovant, and Merck, and is a member of the board of directors for Rythera Therapeutics. KEH: Research Funding (to my institution from): Varian Medical Systems, Rising Tide Foundation, Janssen Scientific Affairs. SH: Member of DSMB for Aveo, BMS, J&J, Sanofi. LEH: none. MA: none. DJG has research support (to Duke University) from Acerta, Astellas, BMS, Bayer, Calithera, Exelixis, Janssen, Myovant, Pfizer, Novartis, and Sanofi Aventis, and consulting income from Vizuri Health Sciences, UroToday, Sanofi, Pfizer, Nektar, Myovant, Modra, Merck, Ipsen, Flatiron, Exelixis, Capio, EMD Serono, BMS, Bayer, AstraZeneca, and Astellas. TZ has received research funding (to Duke) from Pfizer, Janssen, Acerta, AbbVie, Novartis, Merrimack, OmniSeq, PGDx, Merck, Mirati, Astellas, and Regeneron; consulting and speaking income from Genentech Roche, Exelixis, Genomic Health, and Sanofi Aventis; has received consulting income from AstraZeneca, Bayer, Pfizer, Foundation Medicine, Janssen, Amgen, MJH Associates, Merck, BMS, Pharmacyclics, and Seattle Genetics. WRB: none. WRL: none. MRH has research funding (to Duke University) from Argos, Bayer, BMS, Exelixis, Pfizer, Merck, and Seattle Genetics and has received consulting and speaking income from BMS, Genentech Roche, Exelixis, and Janssen. PGC receives institutional funding support from Janssen. AJA: Research support (to Duke) from the NIH/NCI, PCF/Movember, DOD, Astellas, Pfizer, Bayer, Janssen, Dendreon, BMS, AstraZeneca, Merck, Forma, Celgene, Amgen, Novartis. Consulting or advising relationships with Astellas, Epic Sciences, Pfizer, Bayer, Janssen, Dendreon, BMS, AstraZeneca, Merck, Forma, Celgene, Clovis, Exact Sciences, Myovant, Exelixis, GoodRx, Novartis.
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Fecteau, R.E., Koontz, B.F., Hoffman, K.E. et al. Updated 5-year results for short course abiraterone acetate and LHRH agonist for unfavorable intermediate and favorable high-risk prostate cancer. Prostate Cancer Prostatic Dis (2024). https://doi.org/10.1038/s41391-024-00811-5
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DOI: https://doi.org/10.1038/s41391-024-00811-5