Early Hormone Therapy In Men With A Rising PSA Live Longer Then Men Who Delay Therapy – A Phase 3 Trial

The standard of care is to offer androgen deprivation therapy (ADT) to men with prostate cancer who have a rising prostate specific antigen (PSA) after an attempt to cure their cancer with primary therapy that has failed (PSA relapse) or in men who are considered not suitable for curative treatment. The question is what is the optimal timing to begin ADT. Researchers asked if immediate ADT improves overall survival compared with delayed therapy.

They created a randomized, multi-center, phase 3, non-blinded trial; recruiting men from 29 oncology centers in Australia, New Zealand, and Canada. Eligibility included men with prostate cancer who had a PSA relapse after previous attempted curative therapy; including radiotherapy, surgery (with or without postoperative radiotherapy) or if they were not considered suitable for curative treatment because of their age, comorbidity, or locally advanced disease status.

They found that with 5 years follow up from the date of randomization 16 (11%) men died in the immediate therapy arm and 30 (20%) died in the delayed therapy arm.

Twenty-three men had grade 3 treatment-related adverse events, however the adverse did not differ between the two groups. The most common serious adverse events were cardiovascular, which occurred in nine (6%) of the men in the delayed therapy arm and 13 (9%) in the immediate therapy arm.

According to the researcher’s findings, immediate receipt of androgen-deprivation therapy significantly improved overall survival compared with delayed intervention in men with PSA relapsed or non-curable prostate cancer. The results provide benchmark evidence of survival rates and morbidity to discuss with men when considering their treatment options.

Trials Registry (ACTRN12606000301561) and ClinicalTrials.gov (NCT00110162).

The Lancet. Oncology; Duchesne, Woo, Bassett etal;2016 May 04