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

NCT04729114 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2026-02-04

No results posted yet for this study

Summary

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.

Conditions

  • Prostate Cancer
  • Metastatic Castration Resistant Prostate Cancer
  • Metastatic Castration-sensitive Prostate Cancer

Interventions

DRUG

PRL-02 injection

abiraterone decanoate for intramuscular injection

DRUG

prednisone

Oral dose

DRUG

dexamethasone

Oral dose

DRUG

enzalutamide

Oral capsule

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Central Contact · Astellas Pharma Global Development, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2029-05-31
Completion
2029-05-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04729114 on ClinicalTrials.gov