Actively Recruiting
A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-02-04
174
Participants Needed
25
Research Sites
415 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological evidence of adenocarcinoma of the prostate
- For dose escalation groups, documented metastatic castration-sensitive or castration-resistant prostate cancer
- Evidence of disease progression by scans or PSA levels as defined
- Prior hormone therapy requirements depend on study group
- Serum testosterone level below 50 ng/dL for mCRPC participants
- Adequate muscle mass for injection and ECOG performance status of 0 or 1
- Adequate bone marrow, kidney, and liver function as specified
- Serum albumin at least 3 gm/dL and serum potassium at least 3.5 mEq/L
- Willingness to use effective contraception if sexually active with a female partner of childbearing potential
- Ability to comply with study requirements throughout the study
- For Group H, ability to swallow enzalutamide capsules whole
You will not qualify if you...
- Known active central nervous system metastases, unless treated and stable
- Impending bone fracture due to bone metastases
- Other active malignancies requiring treatment, except certain treated skin or early-stage cancers in remission
- Significant cardiac diseases including uncontrolled arrhythmias or heart failure above NYHA Class II
- Uncontrolled hypertension or recent thrombotic events
- Recent investigational drug or chemotherapy use within specified timeframes
- Unresolved significant toxicity from prior cancer therapy
- Recent major surgery or trauma or recent blood transfusion
- History of pituitary or adrenal gland disorders
- Prior treatments with abiraterone acetate or certain hormone therapies depending on group
- Current use of systemic ketoconazole or CYP17 inhibitors, or recent systemic azole drugs
- Use of estrogens within 12 weeks before study drug
- Need for systemic glucocorticoids beyond replacement doses
- Use of herbal products lowering PSA or high-dose biotin supplements
- Use of strong CYP3A4 inducers except enzalutamide in Group H
- Known hypersensitivity to study drugs or excipients
- Active liver disease or infections including hepatitis or uncontrolled HIV
- Poorly controlled diabetes with high HbA1c
- Body mass index over 40 kg/m2
- For Group H, additional cardiac conditions, seizure history, prohibited medication use, gastrointestinal absorption disorders, or hypersensitivity to capsule components
AI-Screening
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Trial Site Locations
Total: 25 locations
1
Arizona Urology Specialists
Tucson, Arizona, United States, 85715
Withdrawn
2
Los Angeles Cancer Network
Anaheim, California, United States, 92801
Actively Recruiting
3
Providence Medical Group Oncology Santa Rosa
Santa Rosa, California, United States, 95403
Actively Recruiting
4
Florida Urology Partners
Tampa, Florida, United States, 33609
Withdrawn
5
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States, 46804
Withdrawn
6
First Urology
Jeffersonville, Indiana, United States, 47130
Actively Recruiting
7
Wichita Urology Group
Wichita, Kansas, United States, 67226
Actively Recruiting
8
National Cancer Institute
Bethesda, Maryland, United States, 20892
Withdrawn
9
Chesapeake Urology
Towson, Maryland, United States, 21204
Actively Recruiting
10
XCancer Center Omaha/Urology Cancer Center
Omaha, Nebraska, United States, 68130
Completed
11
Garden Sate Urology
Morristown, New Jersey, United States, 07960
Withdrawn
12
New Mexico Oncology Hematology Consultants Ltd
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
13
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
14
Helios Clinical Research, LLC
Middleburg Heights, Ohio, United States, 44130
Withdrawn
15
Toledo Clinical Cancer Center
Toledo, Ohio, United States, 43623
Withdrawn
16
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
17
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
18
Urology Associates PC
Nashville, Tennessee, United States, 37209
Actively Recruiting
19
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
Actively Recruiting
20
Houston Metro Urology
Houston, Texas, United States, 77027
Actively Recruiting
21
Oncology Consultants
Houston, Texas, United States, 77030
Withdrawn
22
Urology San Antonio
San Antonio, Texas, United States, 78229
Withdrawn
23
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
24
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Actively Recruiting
25
Pan American Center for Oncology Trials, LLC
San Juan, Rio Piedras, Puerto Rico, 00935
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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