OncoMatch/Clinical Trials/NCT04729114
A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
Is NCT04729114 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including PRL-02 and prednisone for prostate cancer.
Treatment: PRL-02 · prednisone · dexamethasone · enzalutamide — Medicines that reduce the amount of testosterone in the body are commonly used to treat prostate cancer. PRL-02 depot is a potential treatment for men with advanced prostate cancer. It is given by an injection into the muscle. Men with advanced prostate cancer can take part in this study. Their cancer has come back after previous cancer treatment, or the previous cancer treatment they had didn't work. The main aims of the study are: * to check the safety of PRL-02 depot given with and without another medicine called enzalutamide. * to check if the men can tolerate PRL-02 depot given with or without enzalutamide. * to find a suitable dose of PRL-02 depot. This study will be in 2 parts. In the first part, different small groups of men will receive lower to higher doses of PRL-02 depot together with other medicines. In the second part of the study, men who have previously taken a hormone therapy called abiraterone acetate or have previously taken 1 specific hormone therapy as part of their prostate cancer treatment can take part. Men in both parts of the study will receive injections of PRL-02 depot into a muscle once every 12 weeks. They will also take dexamethasone or prednisone, or enzalutamide once a day. The other medicines they take depend on which group and which part of the study they are in. During the study, the men will visit the clinic several times for health checks and scans. After the final visit, men whose cancer has not become worse will continue to have health checks and scans every few months.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IV, NON-METASTATIC, CASTRATION-RESISTANT, CASTRATION-SENSITIVE
mCSPC, nmCSPC with biochemical relapse, mCRPC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: androgen deprivation therapy (GnRH agonist, GnRH antagonist) — mCRPC, mCSPC, nmCSPC with biochemical recurrence
Participants with mCRPC must have undergone bilateral orchiectomy or received concurrent GnRH agonist or antagonist therapy for at least 6 weeks prior to the first dose of study drug. Participants with mCSPC or nmCSPC with biochemical recurrence should have received <6 months of ADT with a GnRH agonist or antagonist or have a history of bilateral orchiectomy (i.e., surgical or medical castration) within 6 months prior to Day 1.
Cannot have received: androgen receptor pathway inhibitor (abiraterone acetate, enzalutamide, apalutamide, darolutamide)
Exception: Allowed in Group D (abiraterone acetate), Group E (one of enzalutamide, apalutamide, or darolutamide), and Group H (abiraterone acetate)
Prior treatment with abiraterone acetate, orteronel. Exception: participants in Phase 1b Expansion Group D will have received prior abiraterone acetate, and participants in Group H may have received prior treatment with abiraterone acetate.
Cannot have received: CYP17 inhibitor (ketoconazole, orteronel)
Exception: Participants who have received systemic ketoconazole or any other CYP17 inhibitor must have discontinued these agents ≥4 weeks prior to the first dose of study drug.
Current treatment with systemic ketoconazole or any other CYP17 inhibitor. Participants who have received systemic ketoconazole or any other CYP17 inhibitor must have discontinued these agents ≥4 weeks prior to the first dose of study drug.
Cannot have received: azole antifungal (fluconazole, itraconazole)
Prior systemic treatment with an azole drug (e.g., fluconazole, itraconazole) within 4 weeks of first dose of study drug.
Cannot have received: estrogen
Prior treatment with estrogens within 12 weeks of the first dose of study drug
Cannot have received: chemotherapy
Exception: ARPI-naïve mCRPC participants enrolled in the Dose Escalation Cohorts (including backfill) must not have received prior chemotherapy in the mCRPC setting (prior receipt of chemotherapy in the mCSPC setting is allowed, if received at least 2 weeks or 5 half-lives prior to the first dose of study drug).
Received chemotherapy within 2 weeks or 5 half-lives (whichever is shorter) of the first dose of study drug. Additional criteria: ARPI-naïve mCRPC participants enrolled in the Dose Escalation Cohorts (including backfill) must not have received prior chemotherapy in the mCRPC setting (prior receipt of chemotherapy in the mCSPC setting is allowed, if received at least 2 weeks or 5 half-lives prior to the first dose of study drug).
Cannot have received: investigational drug
Received an investigational drug within 4 weeks or 5 half-lives (whichever is shorter) of the first dose of study drug.
Cannot have received: herbal product that could decrease PSA levels (saw palmetto)
Prior use of any herbal products that could decrease PSA levels (e.g., saw palmetto) within 4 weeks of the first dose of study drug. Participants must agree not to use such herbal products during study participation.
Lab requirements
Blood counts
ANC ≥1500/µL; Platelet count ≥100,000/µL; Hemoglobin ≥9 gm/dL
Kidney function
serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50 mL/min
Liver function
ALT and AST ≤2.5 × ULN and total bilirubin ≤1.5 × ULN. Exception for elevated bilirubin secondary to Gilbert's disease.
Cardiac function
No clinically significant cardiac disease as defined in exclusion criteria; QTcF <450 msec at screening; LVEF ≥50% at baseline; no NYHA Class III/IV CHF unless LVEF ≥45% (Group H); no Mobitz II second-degree or third-degree heart block without pacemaker (Group H); no hypotension (SBP <86 mmHg, Group H); no bradycardia (HR ≤45 bpm, Group H)
Adequate bone marrow reserve, renal, hepatic function as defined in inclusion criteria. Cardiac exclusion criteria as listed.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arizona Urology Specialists · Tucson, Arizona
- Los Angeles Cancer Network · Anaheim, California
- Providence Medical Group Oncology Santa Rosa · Santa Rosa, California
- Florida Urology Partners · Tampa, Florida
- Fort Wayne Medical Oncology and Hematology, Inc. · Fort Wayne, Indiana
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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