This is a multicenter, Phase II randomized biomarker-based therapeutic study in metastatic prostate cancer experiencing prostate specific antigen (PSA) only progression (without visceral, bone or lymph node progression) while on abiraterone therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
High dose Dutasteride (3.5 mg daily) as add-on therapy at time of PSA progression
1000 mg PO daily
Number of patients with radiographic progression free survival (rPFS) rate
Count the the number of patients with radiographic progression free survival (rPFS)
Time frame: 24 Weeks after study treatment
Determine overall survival (OS)
The Kaplan-Meier product-limit estimator will be used to estimate OS distribution
Time frame: 24 months from start of treatment assignment
Number of patients with a PSA decline of ≥ 50%
Count the number of patients with serologic progression. It is defined as an increase in the PSA level of more than 50% above the nadir with two consecutive increases confirmed at least 2 weeks apart.
Time frame: 24 weeks of adding of adding high-dose dutasteride
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