Can men on AS be treated with testosterone?

Transcription

1 Can men on AS be treated with testosterone? Professor Bertrand Tombal, MD, PhD Cliniques universitaires Saint-Luc Université catholique de Louvain Brussels, Belgium

2 Conflicts of interest PI or member steering committee: Amgen, Astellas, Bayer, Medivation, Ferring, Sanofi-Genzyme Paid Advisor or Consultant for: Amgen, Bayer, Astellas, Ferring, Sanofi-Genzyme

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4 AS is becoming the standard of care of low-risk PCa and gaining interest in some intermediate risk. Focal therapy is, after all, a new form of AS. The coexistence of low-risk PCa and hypogonadism is more frequent.

5 Two different questions. Is there a role for Testosterone Replacement Therapy (TRT) to reduce the risk of progression of hypo-gonadal men on AS? Should somebody with symptomatic hypogonadism be denied TRT because is on AS for a localized PCa.

6 5α-reductase inhibitor reduce the risk of low risk prostate cancer

7 5α-reductase inhibitor reduce the risk of progression of low risk prostate cancer

8 T supplementation and risk of PCa Rhoden EL and Morgentaler A, NEJM 2004, 350:482-92

9 Survival and cardiovascular events in men treated with testosterone replacement therapy: an intention-to-treat observational cohort study. Wallis CJ, Lancet Diabetes Endocrinol Jun;4(6): Population-based matched cohort study of men aged 66 years or older newly treated with TRT (n= ) and controls (n=28 029) matched for age, region of residence, comorbidity, diabetes status, and index year from in Ontario, Canada,

10 Two different questions. Is there a role for Testosterone Replacement Therapy (TRT) to reduce the risk of progression of hypo-gonadal men on AS? Should somebody with symptomatic hypogonadism be denied TRT because is on AS for a localized PCa?

11 Variation in Testosterone Levels and Health-related Quality of Life in Men Diagnosed With Prostate Cancer on Active Surveillance. Cohen A, Urology May AS patients were grouped as having low, low-normal, or normal testosterone levels (< 300 vs vs 400 ng/dl). Surveyed with EPIC-26 and PROMIS, MAS,

12 Variation in Testosterone Levels and Health-related Quality of Life in Men Diagnosed With Prostate Cancer on Active Surveillance. Cohen A, Urology May 11.

13 Effect of testosterone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial. Marks LS et al. JAMA Nov 15;296(19):

14 Effect of testosterone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial. Marks LS et al. JAMA Nov 15;296(19):

15 Effect of T supplementation on PSA in eugonadal young and older men a) Bhasin S et al. Am J Physiol Endocrinol Metab 2001;281:E b) Bhasin S et al. J Clin Endocrinol Metab 2005;90:

16 Testosterone Therapy in Men With Prostate Cancer Alan L. Kaplan et al. European Urology 69 (2016 ) An important paradigm shift has occurred within the field, in which testosterone therapy may now be regarded as a viable option for selected men with prostate cancer suffering from testosterone deficiency.

17 3 trials on AS, 47 patients Alan L. Kaplan et al. European Urology 69 (2016 )

18 Testosterone Therapy in Patients with Treated and Untreated Prostate Cancer: Impact on Oncologic Outcomes. Ory J, J Urol Apr hypogonadal men with Pca who were treated with testosterone therapy. They included 50 men treated with radiation therapy, 22 treated with radical prostatectomy, 8 on active surveillance, 1 treated with cryotherapy and 1 who nderwent high intensity focused ultrasound

19 Can testosterone therapy be offered to men on active surveillance for prostate cancer? Preliminary results. Kacker R. Asian J. Androl Jan-Feb;18(1): A retrospective chart review identified 28 men with T deficiency who underwent T therapy (T group) for at least 6 months while on AS for PCa. A comparison group of 96 men on AS for PCa with untreated T deficiency (no-t group) was identified at the same institution. The AS protocol followed a modified Epstein criteria and allowed inclusion of men with a single core of low-volume Gleason PCa.

20 Kacker R. Asian J. Androl Jan-Feb;18(1):16-20.

21 Biopsy progression in the T and no-t groups, along with historical controls Modified from Kacker R. Asian J. Androl Jan-Feb;18(1):16-20.

22 Should somebody with symptomatic hypogonadism be denied TRT because is on AS for a localized PCa? We have no prospective trial We have weak evidence that there is no short-term harms With careful implementation of biopsy (and imaging) monitoring I don t see arguments denying TRT. I would recommend gels for at least 12 months.