RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)
Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
Single-arm, single site, open label study of the effects of parenteral testosterone followed
by enzalutamide, abiraterone or castration-only therapy in men with metastatic CRPC who
previously progressed on one of these forms of therapy. The study will enroll four cohorts of
patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A; n=30); men
with metastatic CRPC who have progressed on abiraterone acetate (Cohort B; n=30); men with
metastatic CRPC who have progressed on first line castration-only therapy (Cohort C; n=30);
men with metastatic CRPC with inactivating somatic or germline mutations in ≥2 of the genes
TP53, PTEN, or RB1 (Cohort D; n=20).
Phase:
Phase 2
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins