A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
Public ClinicalTrials.gov record NCT04729114. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04729114
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 174 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 13, 2021
- Primary completion
- May 30, 2029
- Completion
- May 30, 2029
- Last update posted
- Feb 3, 2026
2021 – 2029
United States locations
- U.S. sites
- 24
- U.S. states
- 17
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Urology Specialists | Tucson | Arizona | 85715 | Withdrawn |
| Los Angeles Cancer Network | Anaheim | California | 92801 | Recruiting |
| Providence Medical Group Oncology Santa Rosa | Santa Rosa | California | 95403 | Recruiting |
| Florida Urology Partners | Tampa | Florida | 33609 | Withdrawn |
| Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | 46804 | Withdrawn |
| First Urology | Jeffersonville | Indiana | 47130 | Recruiting |
| Wichita Urology Group | Wichita | Kansas | 67226 | Recruiting |
| National Cancer Institute | Bethesda | Maryland | 20892 | Withdrawn |
| Chesapeake Urology | Towson | Maryland | 21204 | Recruiting |
| XCancer Center Omaha/Urology Cancer Center | Omaha | Nebraska | 68130 | Completed |
| Garden Sate Urology | Morristown | New Jersey | 07960 | Withdrawn |
| New Mexico Oncology Hematology Consultants Ltd | Albuquerque | New Mexico | 87109 | Recruiting |
| Duke Cancer Center | Durham | North Carolina | 27710 | Recruiting |
| Helios Clinical Research, LLC | Middleburg Heights | Ohio | 44130 | Withdrawn |
| Toledo Clinical Cancer Center | Toledo | Ohio | 43623 | Withdrawn |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | Recruiting |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | Recruiting |
| Urology Associates PC | Nashville | Tennessee | 37209 | Recruiting |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | Recruiting |
| Houston Metro Urology | Houston | Texas | 77027 | Recruiting |
| Oncology Consultants | Houston | Texas | 77030 | Withdrawn |
| Urology San Antonio | San Antonio | Texas | 78229 | Withdrawn |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | Recruiting |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04729114, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 3, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04729114 live on ClinicalTrials.gov.