Timing of androgen deprivation therapy for prostate cancer patients after radiation: Planned combined analysis of two randomized phase 3 trials.

Authors

Andrew Loblaw

Andrew Loblaw

Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada

Andrew Loblaw , Julie Bassett , Catherine D'Este , Gregory Russell Pond , Patrick Cheung , Jeremy Laurence Millar , Mark Frydenberg , Madeleine Trudy King , Himu Lukka , Shawn Malone , Roger L Milne , Tom Pickles , Rosemary Smith , Martin R. Stockler , Sandra Turner , Keen Hun Tai , Henry Woo , Gillian M. Duchesne

Organizations

Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada, Cancer Epidemiology Centre, Cancer Council Victoria, Melbourne, Australia, NCEPH, Australian National University, Canberra, Australia, McMaster University, Hamilton, ON, Canada, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada, Radiation Oncology, Alfred Health, Melbourne Victoria, Australia, Monash University Faculty of Medicine, Clayton, Australia, Psycho-Oncology Co-operative Research Group (PoCoG), University of Sydney, Sydney, Australia, Hamilton Health Sciences Centre, Hamilton, ON, CA, The Ottawa Hospital, Ottawa, ON, Canada, Cancer Council Victoria, Melbourne, Australia, BC Cancer Agency, Vancouver, BC, Canada, Cancer Council Victoria Clinical Trials Office, Melbourne, Australia, NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia, Crown Princess Mary Cancer Centre, Westmead, Australia, Peter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre, Melbourne, Australia, Westmead Hospital, Sydney, Australia, Peter MacCallum Cancer Centre, Melbourne, Australia

Research Funding

Other

Background: The TOAD (TROG 03.06; NCT00110162) phase 3 randomized trial showed that immediate androgen deprivation therapy (IADT) improved overall survival (OS) and time to clinical progression compared with delayed ADT (DADT) in progressive or relapsed prostate cancer patients after radical radiotherapy (RT) or prostatectomy + RT. ELAAT (NCT00439751) was a similarly designed trial but failed to reach its accrual goal. The two investigative teams planned a combined analysis before ELAAT was activated. Methods: The PSA failures from TOAD and 78/79 patients accrued to ELAAT were combined (1 patient was excluded due to castrate resistant prostate cancer (CRPC)). Participants for both trials were randomized 1:1 to IADT or DADT. The primary endpoint was all-cause mortality by intention-to-treat. Secondary endpoints were cancer-specific mortality (CSM), local progression, distant progression, CRPC, and prostate cancer complications (PCC). Results: 261 patients from TOAD and 78 patients from ELAAT were followed a median of 5.0y. TOAD patients were younger (mean age 70.5 vs 73.8y) and more had a relapse-free interval < 2y from RT (30% vs 10%). In the DADT arms, 63% received ADT a median of 1.58y for TOAD; 38% received ADT a median 1.65y for ELAAT. For patients receiving ADT, the mean pre-ADT PSAs were 3.52 and 30.2 ng/ml in the IADT and DADT arms of TOAD and 3.98 and 18.1 ng/ml in ELAAT. There were 60 deaths, 40 and 20 respectively. Overall, for IADT and DADT arms the proportions of deaths in each trial were 15%, 11%, 19% and 26%, 27% and 24%. All-cause mortality (HR 0.75, 95% CI 0.40, 1.41; p = 0.37) and CSM (HR 0.57, 95% CI 0.22, 1.49) were not statistically different between IADT and DADT. Time to local progression (survival time ratio 1.97, 95% CI 1.28, 3.04; p = 0.002) and distant progression (survival time ratio 1.28, 95% CI 1.04, 1.58; p = 0.02) was higher while PCC (3.7 v 7.5%, p = 0.06) was lower with IADT. CRPC outcomes will be presented at conference. Conclusions: No difference in OS was detected between IADT and DADT in the combined analysis. A possible explanation is that ELAAT accrued older patients with lower risk of CSM and had a smaller difference in PSA between the IADT and DADT arms.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Genitourinary (Prostate) Cancer

Track

Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track

Other Prostate, Testicular, or Penile Cancer

Citation

J Clin Oncol 36, 2018 (suppl; abstr 5018)

DOI

10.1200/JCO.2018.36.15_suppl.5018

Abstract #

5018

Poster Bd #

245

Abstract Disclosures