A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
Phase 1, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer
1 other identifier
interventional
174
2 countries
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 prostate-cancer
Started Jun 2021
Longer than P75 for phase_1 prostate-cancer
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 28, 2021
CompletedStudy Start
First participant enrolled
June 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2029
February 4, 2026
February 1, 2026
8 years
January 15, 2021
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Incidence of Dose Limiting Toxicities (DLTs)
A DLT is defined as any event meeting the DLT criteria during the first 28 days of each Dose Escalation treatment regardless of attribution to the study drug unless due to underlying disease or extraneous causes.
Up to 28 days
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to 4 years
Number of Participants with Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important events.
Up to 4 years
Number of Participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Up to 4 years
Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Up to 4 years
Number of Participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Up to 4 years
Number of Participants with physical exam abnormalities and/or AEs
Number of participants with potentially clinically significant physical exam values or symptoms.
Up to 4 years
Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status score
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Up to 4 years
Testosterone Suppression of Participants as Assessed by Testosterone Levels
Reduction in testosterone will be summarized by group and dose level.
Up to 4 years
Secondary Outcomes (38)
Pharmacokinetics (PK) of Abiraterone in plasma: Maximum Concentration (Cmax)
Up to 455 days
PK of Abiraterone Decanoate in plasma: Cmax
Up to 455 days
PK of Abiraterone Metabolite in plasma: Cmax
Up to 455 days
PK of Abiraterone in plasma: Minimum Concentration (Cmin)
Up to 455 days
PK of Abiraterone Decanoate in plasma: Cmin
Up to 455 days
- +33 more secondary outcomes
Study Arms (5)
Phase 1a Dose Escalation: Group A
EXPERIMENTALParticipants with metastatic castration-sensitive prostate cancer (mCSPC), nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical relapse, or metastatic castration-resistant prostate cancer (mCRPC) will receive escalating doses of PRL-02 + prednisone.
Phase 1a Dose Escalation: Group B
EXPERIMENTALParticipants with mCSPC, nmCSPC with biochemical relapse, or mCRPC will receive escalating doses of PRL-02 + dexamethasone.
Phase 1a Dose Escalation: Group H
EXPERIMENTALParticipants with mCSPC or mCRPC will receive escalating doses of PRL-02 + dexamethasone + enzalutamide.
Phase 1b Dose Expansion: Group D
EXPERIMENTALParticipants with mCRPC with prior treatment with abiraterone acetate will receive escalating doses of PRL-02 + dexamethasone.
Phase 1b Dose Expansion: Group E
EXPERIMENTALParticipants with mCRPC with prior treatment with 1 of the following androgen receptor pathway inhibitor (ARPIs) (enzalutamide, apalutamide, and/or darolutamide) will receive escalating doses of PRL-02 + dexamethasone.
Interventions
Oral dose
abiraterone decanoate for intramuscular injection
Eligibility Criteria
You may qualify if:
- Histological evidence of adenocarcinoma of the prostate
- Phase 1a Dose Escalation Groups A and B: participants must have one of the following documented conditions:
- mCSPC (must have documentation by positive bone scan \[for bone disease\] or metastatic lesions on computed tomography \[CT\] or magnetic resonance imaging \[MRI\] scan \[for soft tissue\])
- nmCSPC with biochemical relapse of prostate cancer
- mCSPC with oligometastatic prostate cancer (e.g., positron emission tomography positive)
- mCRPC (must have documentation by positive bone scan \[for bone disease\] or metastatic lesions on CT or MRI scan \[for soft tissue\])
- NOTE: For participants in the Dose Escalation Cohorts (including backfill) at each of the dose levels up to approximately 10 participants with ARPI-naïve mCRPC who have not received prior treatment with an ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide) will be enrolled.
- Phase 1a Dose Escalation Groups A and B: participants with mCRPC must have evidence of disease progression defined as one or more of the following:
- Evidence of radiographic progression of disease following the most recent prostate cancer treatment, defined as progressive disease on CT/MRI per RECIST v1.1 or on a bone scan per PCWG3.
- PSA progression defined as the following:
- PSA nadir is defined as the lowest PSA during or after the most recent treatment. PSA progression is defined as an increased PSA of at least 25% and ≥1 ng/mL above the nadir confirmed by at least 2 measurements with a minimum of 1 week apart, and with at least 1 of the measurements within 90 days prior to screening.
- Participants with nmCSPC and biochemical recurrence, who had a radical prostatectomy (with or without radiotherapy) as the primary treatment for prostate cancer, must have a screening PSA ≥1 ng/mL. Participants with nmCSPC and biochemical recurrence who had radiotherapy only, as primary treatment for prostate cancer, must have a screening PSA ≥2 ng/mL above the nadir.
- Phase 1b Expansion Groups D and E: participants must have mCRPC Participants in Group D must have received prior treatment with abiraterone acetate, but must not have received treatment with other ARPIs (enzalutamide, apalutamide or darolutamide). Participants in Group E must have received prior treatment with only 1 of the following ARPIs: enzalutamide, apalutamide or darolutamide. Participants in both Groups D and E must have documented evidence of progression with one or more of the following:
- Evidence of radiographic progression of disease following the most recent prostate cancer treatment, defined as progressive disease on CT/MRI per RECIST v1.1 or on a bone scan per PCWG3. Disease spread that is limited to the regional pelvic lymph nodes does not qualify as radiographic progression.
- PSA progression defined as the following:
- +24 more criteria
You may not qualify if:
- Known active central nervous system (CNS) metastases. Note: Participants with CNS metastases that have been treated with surgery and/or radiation therapy, who are off pharmacologic doses of glucocorticoids, and who are neurologically stable are eligible.
- Impending bone fracture due to bone metastases
- Has a known additional malignancy beyond prostate cancer that required active treatment with the exception of any of the following:
- Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type
- Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥2 years
- Any other cancer from which the participant has been disease-free for ≥5 years
- Clinically significant cardiac disease, defined as any of the following:
- Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled.
- Congenital long QT syndrome
- QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at screening (based on average of triplicate ECGs at baseline). If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the Medical Monitor.
- History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \<50% at baseline. Participants must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months \[NYHA Classification 2014\].
- Uncontrolled hypertension, defined as systolic blood pressure (BP) \>160 mmHg or diastolic BP \>100 mmHg which has been confirmed by 2 successive measurements despite optimal medical management.
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring \>1 month before the start of study medication).
- Received an investigational drug within 4 weeks or 5 half-lives (whichever is shorter) of the first dose of study drug.
- Received chemotherapy within 2 weeks or 5 half-lives (whichever is shorter) of the first dose of study drug.
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Arizona Urology Specialists
Tucson, Arizona, 85715, United States
Los Angeles Cancer Network
Anaheim, California, 92801, United States
Providence Medical Group Oncology Santa Rosa
Santa Rosa, California, 95403, United States
Florida Urology Partners
Tampa, Florida, 33609, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46804, United States
First Urology
Jeffersonville, Indiana, 47130, United States
Wichita Urology Group
Wichita, Kansas, 67226, United States
National Cancer Institute
Bethesda, Maryland, 20892, United States
Chesapeake Urology
Towson, Maryland, 21204, United States
XCancer Center Omaha/Urology Cancer Center
Omaha, Nebraska, 68130, United States
Garden Sate Urology
Morristown, New Jersey, 07960, United States
New Mexico Oncology Hematology Consultants Ltd
Albuquerque, New Mexico, 87109, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Helios Clinical Research, LLC
Middleburg Heights, Ohio, 44130, United States
Toledo Clinical Cancer Center
Toledo, Ohio, 43623, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Urology Associates PC
Nashville, Tennessee, 37209, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Oncology Consultants
Houston, Texas, 77030, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Pan American Center for Oncology Trials, LLC
San Juan, Rio Piedras, 00935, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Global Development, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2021
First Posted
January 28, 2021
Study Start
June 14, 2021
Primary Completion (Estimated)
May 31, 2029
Study Completion (Estimated)
May 31, 2029
Last Updated
February 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.