Long-term side-effects of intermittent androgen suppression therapy in prostate cancer: results of a phase II study
Article first published online: 11 AUG 2005
Volume 96, Issue 4, pages 514–520, September 2005
How to Cite
Malone, S., Perry, G., Segal, R., Dahrouge, S. and Crook, J. (2005), Long-term side-effects of intermittent androgen suppression therapy in prostate cancer: results of a phase II study. BJU International, 96: 514–520. doi: 10.1111/j.1464-410X.2005.05676.x
- Issue published online: 11 AUG 2005
- Article first published online: 11 AUG 2005
- Accepted for publication 31 March 2005
- prostate cancer;
- intermittent hormone therapy;
- late side-effects
To assess the feasibility and tolerability of intermittent androgen suppression therapy (IAS) in prostate cancer.
PATIENTS AND METHODS
Patients with recurrent or metastic prostate cancer received cyclical periods of treatment with leuprolide acetate and nilutamide for 8 months, and rest periods. Cycles were repeated at progression until the treatment failed to achieve normal prostate-specific antigen (PSA) levels. Patients were followed with PSA level, testosterone level, haemoglobin level, weight and bone mineral density evaluations. The median time to treatment failure, recovery from anaemia, or normalization of testosterone level was estimated by the Kaplan-Meier method.
In all, 95 patients received 245 cycles; the median duration of rest periods was 8 months and median time to treatment failure 47 months. Testosterone recovery during rest periods was documented in 117 (61%) of cycles. Anaemia was mild and reported in 33%, 44% and 67% of cycles 1, 2 and 3, respectively. Sexual function recovered during the rest periods in 47% of cycles. There was no significant overall change in body mass index at the end of the treatment period. Osteoporosis was documented in at least one site evaluated in 41 patients (37%).
IAS has the potential to reduce side-effects, including recovery of haemoglobin level, return of sexual function and absence of weight gain at the end of the study period.