Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Eligible metastatic castration-sensitive prostate cancer (mCSPC) and metastatic
castration-resistant prostate cancer (mCRPC) patients will be enrolled in the study. Phase 1
(Dose Escalation) of the study is a 3+3 design intended to identify the recommended Phase 2
dose. Phase 2a (Dose Expansion) will confirm the safety, tolerability and pharmacodynamic
effects of the recommended Phase 2 dose. All patients will receive PRL-02 as an i.m.
injection every 84 (+ 3 days) days. In both Phases, patients will undergo scheduled periodic
assessments of serum testosterone levels. All patients may remain on study unless their serum
testosterone is >1 ng/dL on 2 sequential determinations starting on Day 21 through Day 77,
the development of unacceptable toxicity, patient withdrawal of consent, at the discretion of
the investigator or following 4 complete treatment cycles. Patients with a 2nd sequential
serum testosterone is >1 ng/dL at Day 84 will be allowed to continue in the study at the
discretion of the investigator.