Androgen deprivation therapy (ADT) given immediately significantly improved overall survival compared with delayed intervention in patients with prostate-specific antigen (PSA)-relapsed or non-curable prostate cancer, a study published in The Lancet Oncology has shown.1
Although men with prostate cancer who have a rising PSA following curative therapy or who are not eligible to receive curative treatment are offered ADT, the optimal timing for its introduction remains unclear. Therefore, researchers sought to evaluate whether immediate ADT improves survival compared with delayed treatment.
For the multicenter, non-blinded, phase 3 trial, researchers enrolled 293 men with prostate cancer, of which 261 had PSA relapse and 32 had non-curable disease. Participants were randomly assigned 1:1 to receive immediate ADT or delayed ADT with a recommended interval of at least 2 years unless clinically contraindicated.
Results showed that at a median follow-up of 5 years, the 5-year overall survival rate for patients who underwent immediate intervention was 91.2% (95% CI, 84.2-95.2) compared 86.4% (95% CI, 78.5-91.5) in the delayed therapy arm (hazard ratio, 0.55; 95% CI, 0.30-1.00; P = .050).
In regard to safety, 23 patients experienced grade 3 treatment-related adverse events and 105 patients had adverse events that required hospital admission; however, none of these toxicities were related to treatment or differed between the 2 treatment groups.
The most frequently reported serious adverse events were cardiovascular, which occurred in 9% of patients in the immediate therapy group compared with 6% in the delayed intervention arm.
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The findings ultimately provide benchmark evidence of survival rates and morbidity for clinicians to discuss with their patients when discussing treatment management strategies.
- Duchesne GM, Woo HH, Bassett JK, et al. Timing of androgen-deprivation therapy in patients with prostate cancer with a rising PSA (TROG 03.06 and VCOG PR 01-03 [TOAD]): a randomised, multicentre, non-blinded, phase 3 trial [published online ahead of print May 4, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(16)00107-8.