Actively Recruiting
Phase 1, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-02-04
174
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying PRL-02 depot, a potential injectable treatment for men with advanced prostate cancer, including those whose cancer has returned or not responded to previous treatments. The trial aims to evaluate the safety and tolerability of PRL-02 depot alone or combined with enzalutamide, as well as to determine the appropriate dose. This Phase 1 study is sponsored by Astellas Pharma Global Development, Inc. and focuses on men with metastatic or biochemical relapse forms of prostate cancer. Participants will be divided into groups receiving different doses of PRL-02 depot injected into a muscle every 12 weeks. They will also take daily oral doses of either dexamethasone, prednisone, or enzalutamide depending on their study group and prior treatments. The study has two parts: dose escalation with small groups receiving increasing doses, and dose expansion involving men previously treated with specific hormone therapies. During the trial, men will visit the clinic multiple times for health checks, scans, and blood tests to monitor side effects, disease progression, and testosterone suppression. After the final visit, those whose cancer has not worsened will continue to have periodic health assessments and scans. The main outcomes include tracking dose limiting toxicities and adverse events over up to four years, along with detailed pharmacokinetic and response measurements.
CONDITIONS
Brief 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...
- Male with histological evidence of adenocarcinoma of the prostate
- Diagnosed with metastatic castration-sensitive prostate cancer (mCSPC), nonmetastatic castration-sensitive prostate cancer with biochemical relapse, or metastatic castration-resistant prostate cancer (mCRPC)
- Evidence of disease progression by scans or rising PSA levels as defined
- Serum testosterone level below 50 ng/dL for mCRPC participants
- Adequate muscle mass for intramuscular injection
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal, and hepatic function based on lab tests
- Willingness to use effective contraception if heterosexually active and non-sterile
- Ability to comply with study requirements
- For Group H only: ability to swallow enzalutamide capsules whole
You will not qualify if you...
- Known active central nervous system metastases unless treated and stable
- Risk of impending bone fracture due to metastases
- Other active cancers requiring treatment except certain skin or early-stage cancers in remission
- Significant uncontrolled cardiac disease or arrhythmias
- Recent chemotherapy or investigational drug use within defined timeframes
- Unresolved toxicity Grade >2 from previous anticancer therapy
- Recent major surgery or trauma
- Blood transfusion within 2 weeks prior to study drug
- History of adrenal or pituitary gland impairment
- Prior treatment with abiraterone acetate except for certain groups
- Current use of systemic ketoconazole or CYP17 inhibitors without appropriate washout
- Use of certain azole drugs, estrogens, or prohibited medications within specified times
- Known hypersensitivity to study drugs or components
- Active liver disease or jaundice
- Poorly controlled diabetes or uncontrolled HIV infection
- Body mass index over 40 kg/m2
- For Group H only: specific cardiac conditions, history of seizures, gastrointestinal disorders affecting absorption, or hypersensitivity to capsule components
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 28 days for dose limiting toxicity assessment and continued treatment up to 4 years
Participants receive escalating doses of PRL-02 depot via intramuscular injection combined with prednisone, dexamethasone, and/or enzalutamide depending on their assigned group.
Multiple visits for dosing and assessments during treatment period
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.
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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