Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
NCT04729114 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG enzalutamide
- DRUG prednisone
- DRUG dexamethasone
- DRUG PRL-02 injection
Study Locations (20)
California
- Los Angeles Cancer Network — Anaheim
- Providence Medical Group Oncology Santa Rosa — Santa Rosa
Indiana
- Fort Wayne Medical Oncology and Hematology, Inc. — Fort Wayne
- First Urology — Jeffersonville
Maryland
- National Cancer Institute — Bethesda
- Chesapeake Urology — Towson
Ohio
- Helios Clinical Research, LLC — Middleburg Heights
- Toledo Clinical Cancer Center — Toledo
Texas
- Urology Clinics of North Texas — Dallas
- Houston Metro Urology — Houston
Arizona
- Arizona Urology Specialists — Tucson
Florida
- Florida Urology Partners — Tampa
Kansas
- Wichita Urology Group — Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2029-05-31 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04729114
The ClinicalTrials.gov registry entry for NCT04729114 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions — of which enzalutamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04729114 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Indiana, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04729114 about?
NCT04729114 is a clinical study titled "A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer". 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 canc...
What is the current status of trial NCT04729114?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 174 participants. The study started on 2021-06-14. Estimated completion is 2029-05-31.
What conditions does trial NCT04729114 study?
This clinical trial studies the following conditions: Prostate Cancer, Metastatic Castration Resistant Prostate Cancer, Metastatic Castration-sensitive Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04729114?
The interventions under investigation include: enzalutamide (DRUG), prednisone (DRUG), dexamethasone (DRUG), PRL-02 injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04729114?
This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04729114 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.