Biomarker Study of in Men With PSA Progression on Abi for CR or CS PC (Bio-STAMP)
NCT05705700 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2023-02-27
Summary
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.
Conditions
Interventions
- DRUG
-
Dutasteride
High dose Dutasteride (3.5 mg daily) as add-on therapy at time of PSA progression
- DRUG
-
Abiraterone
1000 mg PO daily
Sponsors & Collaborators
-
Masonic Cancer Center, University of Minnesota
lead OTHER
Principal Investigators
-
Charles Ryan, MD · Masonic Cancer Center, Univeristy of Minnesota
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-28
- Primary Completion
- 2030-01-31
- Completion
- 2030-01-31
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