New Protocol of Intermittent Androgen Deprivation Therapy for Patients With Metastatic Prostate Cancer: A Retrospective Study.

Background: The optimal points for halting and resuming treatment in intermittent androgen deprivation therapy (IADT) for metastatic prostate cancer patients are controversial.

Patients And Methods: In the 65 metastatic prostate cancer patients in group 1, androgen deprivation therapy was stopped when prostate-specific antigen (PSA) levels reached a nadir and was resumed when PSA levels doubled and ≥ 1.0 ng/mL (new protocol). In the 62 patients in group 2, androgen deprivation therapy was stopped 3 months after PSA = 0.2 ng/mL and resumed at PSA ≥ 4.0 ng/mL (Chinese Urological Association guideline). The total IADT duration, overall on-treatment and off-treatment time, tumor clinical progression ratio, performance status improvement, and treatment-related adverse effects were retrospectively analyzed.

Results: In groups 1 and 2, the median total IADT durations were 51 and 46.5 months (significant difference, P = .006), median overall on-treatment times were 28 and 27.5 months (no significant difference, P > .05), and median overall off-treatment times were 23 and 19 months (significant difference, P < .001), respectively. Multivariate Cox regression analysis indicated that patients in group 1 had significantly higher progression-free-survival (hazard ratio, 0.634; P = .014). Two cases of clinical progression occurred group 1 and 5 in group 2; there was no significant difference (P > .05). There were no significant differences between the groups in terms of performance status improvement and treatment-related adverse effects.

Conclusion: The new protocol was found to be beneficial, showing less biochemical/clinical progression, satisfactory performance status, and acceptable treatment-related adverse effects.