The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy).
We have shown in a murine model of treatment with intermittent androgen ablation therapy of prostate cancer that when dutasteride is given during the regrowth phase (off-phase) of intermittent therapy, that tumor growth is inhibited and that survival is improved. We have also shown that testosterone is a more potent inducer of certain tumor suppressor androgen response genes than dihydrotestosterone. In this murine model, we showed that use of a 5-alpha reductase inhibitor (dutasteride) resulted in significant hyperinduction of the U19 tumor suppressor androgen response gene during the regrowth phase of treatment. In the current clinical trial, we will determine if use of dutasteride in men with advanced prostate cancer during the off-phase of intermittent androgen ablation therapy will also result in hyperinduction of these tumor suppressor androgen response genes. Gene expression will be measured in tumor tissue obtained by prostate biopsies during the off-phase when the testosterone level has normalized. Prostate-specific antigen (PSA) levels will also be measured to determine the PSA doubling time during the off-phase to determine the effect of dutasteride on PSA kinetics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
0.5 mg capsule given orally on daily basis
Identical placebo
Northwestern University Medical Center
Chicago, Illinois, United States
University of Chicago Hospitals and Clinics
Chicago, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle.
Calculation of the level of gene expression of the U19 tumor suppressor gene compared between the 2 arms at the end of "off-treatment" cycle 1.
Time frame: At the end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)
Determination of Prostate-specific Antigen (PSA) Doubling Time During First Off-cycle
Calculation of number of months when baseline PSA doubles compared between the 2 arms at the end of "off-treatment" cycle 1.
Time frame: At month 9 and ongoing monthly until end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.