Presentation Authors: John Mulhall*, Nicole Benfante, New York, NY, Patrick Teloken, Dutton Park, Australia, Boback Berookhim, Lawrence Jenkins, New York, NY
Introduction: The administration of exogenous testosterone (T) to men who have undergone radical prostatectomy (RP) for prostate cancer remains controversial. Besides small case series there are no large population, long-term studies assessing the safety of this treatment in this population. We have adopted a policy of allowing the decision regarding T therapy in men post-RP to be a negotiated one with a comprehensive discussion of the data and the pros and cons of T therapy. This prospective study was undertaken to define the safety of exogenous T therapy in men post-RP.
Methods: Men were considered candidates for T therapy if (i) they had two early morning total T level < 300 ng/dl (ii) had symptoms/signs of TD (iii) had pathologically organ-confined, Gleason 6-7 prostate cancer and (iv) an undetectable PSA level post-RP pre-commencement of T therapy. Once men opted for treatment they had labs tested 4 weeks later. T dose was titrated to achieve a serum level of 500-600ng/dl. Patients had serum T levels and PSA checked every 6 months.
Results: A total of 360 patients have been prescribed T therapy to date. Mean age and pre-RP PSA levels were 59Â±12 years and 4Â±6 ng/dl respectively. Baseline total T levels were 228Â±94 (80-296) ng/dl. 48% had a Gleason Score (GS) of 6, 42% had GS 7 disease. Median time post-RP before T therapy was commenced was 9 months (IQR 9, 112) months. 28% were using clomiphene, 56% transdermal T and 16% IM T to achieve therapeutic T levels. Mean post-treatment total T was 520Â±280 (396-920) ng/dl. Median duration on T therapy at last follow-up was 38 (IQR 6, 112) months equating to mean duration post-RP of 66Â±41 months. A single man had a PSA recurrence at a time point 2.5 years post-RP.
Conclusions: In this series of carefully selected patients (Gâ‰¤7, organ confined disease, post-RP undetectable PSA level)the administration of exogenous T for the treatment of TD appears to be safe 3 years post-T administration.