A Safety and Dose-finding Trial of PRL-02 Depot in Men With Advanced Prostate Cancer
Phase 1
174
about 8 years
18+
Male only
24 sites in AZ, CA, FL +14
What this study is about
Researchers are testing the safety and a suitable dose of PRL-02 depot, an injection given into the muscle, for men with advanced prostate cancer. The trial will involve different doses of PRL-02 depot along with other medicines like enzalutamide, dexamethasone, or prednisone. Men who have previously taken hormone therapy will also be included in this trial.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive PRL-02 injection
- 2.Take dexamethasone
- 3.Take enzalutamide
- +1 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
dexamethasone, enzalutamide, prednisone
injection, ocular, oral (Oral Tablet), oral
Primary: Incidence of Dose Limiting Toxicities (DLTs), Number of Participants with Adverse Events (AEs), Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status score, Number of Participants with Serious Adverse Events (SAEs), Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs, Number of Participants with laboratory value abnormalities and/or AEs, Number of Participants with physical exam abnormalities and/or AEs, Number of Participants with vital sign abnormalities and/or AEs
Secondary: Best overall response (BOR) per RECIST v1.1, Composite Response Rate, Duration of response (DOR), Overall response rate (ORR) using RECIST v1.1, Overall survival (OS), PK of Abiraterone Decanoate in plasma: AUCinf, PK of Abiraterone Decanoate in plasma: AUClast, PK of Abiraterone Decanoate in plasma: AUCtau
Oncology