A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer (NCT04729114)
Phase 1, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Arizona Urology Specialists — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (25 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
- First Urology — Jeffersonville, Indiana
- Wichita Urology Group — Wichita, Kansas
- National Cancer Institute — Bethesda, Maryland
- Chesapeake Urology — Towson, Maryland
- XCancer Center Omaha/Urology Cancer Center — Omaha, Nebraska
- Garden Sate Urology — Morristown, New Jersey
- New Mexico Oncology Hematology Consultants Ltd — Albuquerque, New Mexico
- Duke Cancer Center — Durham, North Carolina
- Helios Clinical Research, LLC — Middleburg Heights, Ohio
- Toledo Clinical Cancer Center — Toledo, Ohio
- MidLantic Urology — Bala-Cynwyd, Pennsylvania
- Carolina Urologic Research Center — Myrtle Beach, South Carolina
- Urology Associates PC — Nashville, Tennessee
- Urology Clinics of North Texas — Dallas, Texas
- Houston Metro Urology — Houston, Texas
- Oncology Consultants — Houston, Texas
- Urology San Antonio — San Antonio, Texas
- University of Virginia Cancer Center — Charlottesville, Virginia
- Northwest Medical Specialties — Tacoma, Washington
- Pan American Center for Oncology Trials, LLC — San Juan, Rio Piedras
📞 Contact the Study Coordinator
Phone: (800) 888-7704
Email: Astellas.registration@astellas.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Prostate Cancer
- A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC — Homewood, Alabama
- A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described — Homewood, Alabama
- Stereotactic Ablative Radiation Therapy for Prostate Cancer — Charleston, South Carolina
- A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer — Basking Ridge, New Jersey
- A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer — Phoenix, Arizona
- Neoadjuvant Enoblituzumab (MGA271) in Men With Localized Intermediate and High-Risk Prostate Cancer — Baltimore, Maryland
Explore by condition: All Prostate Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.