Prostate Cancer Clinical Trial
Official title:
Phase 1/2a, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer
A Phase 1/2a, open-label, multicenter study of intramuscular (i.m.) PRL-02 depot in participants with advanced prostate cancer.
Phase 1/2a, open-label, multicenter study of intramuscular (i.m.) PRL-02 depot in participants with castration-sensitive prostate cancer (CSPC) and metastatic castration-resistant prostate cancer (mCRPC). In Phase 1 (Dose Escalation), participants will receive escalating doses of i.m. PRL-02 in 84-day treatment cycles combined with daily oral steroid. In Phase 2a (Dose Expansion), participants with metastatic castration-sensitive prostate cancer (mCSPC) and mCRPC will receive i.m. PRL-02 at one or more recommended Phase 2 doses (RP2Ds) selected from Phase 1 in 84-day treatment cycles in combination with dexamethasone and docetaxel (Group F1) or in combination with dexamethasone (Groups F2, G). In both phases, participants will undergo scheduled periodic assessments of prostate specific antigen (PSA), testosterone and progesterone levels in the blood. ;
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