NCT04729114PHASE1RECRUITING

A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer

Phase 1, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer

Sponsor: Astellas Pharma Global Development, Inc.

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Prostate Cancer, Metastatic Castration Resistant Prostate Cancer, Metastatic Castration-sensitive Prostate Cancer

Interventions

PRL-02 injection, prednisone, dexamethasone, enzalutamide

Enrollment

174 participants

Primary completion

May 2029

Study completion

May 2029

First posted

Jan 2021

Last updated

Feb 2026

Primary Endpoints (CT.gov)

Incidence of Dose Limiting Toxicities (DLTs)

Time frame: Up to 28 days

Number of Participants with Adverse Events (AEs)

Time frame: Up to 4 years

Number of Participants with Serious Adverse Events (SAEs)

Time frame: Up to 4 years

Number of Participants with laboratory value abnormalities and/or AEs

Time frame: Up to 4 years

Secondary Endpoints

Pharmacokinetics (PK) of Abiraterone in plasma: Maximum Concentration (Cmax)

PK of Abiraterone Decanoate in plasma: Cmax

PK of Abiraterone Metabolite in plasma: Cmax

Eligibility Criteria

Inclusion Criteria: * Histological evidence of adenocarcinoma of the prostate * Phase 1a Dose Escalation Groups A and B: participants must have one of the following documented conditions: * mCSPC (must have documentation by positive bone scan \[for bone disease\] or metastatic lesions on computed tomography \[CT\] or magnetic resonance imaging \[MRI\] scan \[for soft tissue\]) * nmCSPC with biochemical relapse of prostate cancer * mCSPC with oligometastatic prostate cancer (e.g., positron emission tomography positive) * mCRPC (must have documentation by positive bone scan \[for bone disease\] or metastatic lesions on CT or MRI scan \[for soft tissue\]) * NOTE: For participants in the Dose Escalation Cohorts (including backfill) at each of the dose levels up to approximately 10 participants with ARPI-naïve mCRPC who have not received prior treatment with an ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide) will be enrolled. * Phase 1a Dose Escalation …

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov