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Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04729114
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Propella Therapeutics

Study Description
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Brief Summary:
Eligible metastatic castration-sensitive prostate cancer (mCSPC) and metastatic castration-resistant prostate cancer (mCRPC) patients will be enrolled in the study. Phase 1 (Dose Escalation) of the study is a 3+3 design intended to identify the recommended Phase 2 dose. Phase 2a (Dose Expansion) will confirm the safety, tolerability and pharmacodynamic effects of the recommended Phase 2 dose. All patients will receive PRL-02 as an i.m. injection every 84 (+ 3 days) days. In both Phases, patients will undergo scheduled periodic assessments of serum testosterone levels. All patients may remain on study unless their serum testosterone is >1 ng/dL on 2 sequential determinations starting on Day 21 through Day 77, the development of unacceptable toxicity, patient withdrawal of consent, at the discretion of the investigator or following 4 complete treatment cycles. Patients with a 2nd sequential serum testosterone is >1 ng/dL at Day 84 will be allowed to continue in the study at the discretion of the investigator.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: abiraterone decanoate Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This is a 3+3 dose escalation study design with a dose expansion phase once a Phase 2 dose is identified.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer
Actual Study Start Date : June 14, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Abiraterone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
The starting dose will be 180 mg of PRL-02 depot (abiraterone decanoate for intramuscular injection)
 Drug: abiraterone decanoate

PRL-02 depot (abiraterone decanoate for intramuscular injection) is a solution formulation of abiraterone decanoate at a concentration of 180 mg/mL and will be provided as a 10 mL vial containing 990 mg of abiraterone decanoate in 5.5 mL of solution.

PRL-02 will be administered as an intramuscular injection every 84 days (+3 days)
Experimental: Cohort 2
Cohort 2 dose will be 360 mg of PRL-02 depot (abiraterone decanoate for intramuscular injection)
 Drug: abiraterone decanoate

PRL-02 depot (abiraterone decanoate for intramuscular injection) is a solution formulation of abiraterone decanoate at a concentration of 180 mg/mL and will be provided as a 10 mL vial containing 990 mg of abiraterone decanoate in 5.5 mL of solution.

PRL-02 will be administered as an intramuscular injection every 84 days (+3 days)
Experimental: Cohort 3
Cohort 3 dose will be 720 mg of PRL-02 depot (abiraterone decanoate for intramuscular injection)
 Drug: abiraterone decanoate

PRL-02 depot (abiraterone decanoate for intramuscular injection) is a solution formulation of abiraterone decanoate at a concentration of 180 mg/mL and will be provided as a 10 mL vial containing 990 mg of abiraterone decanoate in 5.5 mL of solution.

PRL-02 will be administered as an intramuscular injection every 84 days (+3 days)
Experimental: Cohort 4
Cohort 4 dose will be 1260 mg of PRL-02 depot (abiraterone decanoate for intramuscular injection)
 Drug: abiraterone decanoate

PRL-02 depot (abiraterone decanoate for intramuscular injection) is a solution formulation of abiraterone decanoate at a concentration of 180 mg/mL and will be provided as a 10 mL vial containing 990 mg of abiraterone decanoate in 5.5 mL of solution.

PRL-02 will be administered as an intramuscular injection every 84 days (+3 days)
Experimental: Dose Expansion
The recommended Phase 2a dose will be a dose from the cohort dose escalation phase that does not exceed the maximum tolerated dose and adequately suppresses serum testosterone (i.e., to less than or equal to 1 ng/dL) over the course of treatment. More than one dose may be selected for investigation in Phase 2a of the study.
 Drug: abiraterone decanoate

PRL-02 depot (abiraterone decanoate for intramuscular injection) is a solution formulation of abiraterone decanoate at a concentration of 180 mg/mL and will be provided as a 10 mL vial containing 990 mg of abiraterone decanoate in 5.5 mL of solution.

PRL-02 will be administered as an intramuscular injection every 84 days (+3 days)


Outcome Measures
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Primary Outcome Measures :
  1. Testosterone suppression [ Time Frame: Treatment ]
    To determine a preliminary recommended Phase 2 dose of PRL-02 depot that provides adequate testosterone suppression over the course of treatment.


Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: Treatment ]
    Reporting of number of patients with adverse events related to study drug


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent obtained prior to any study-related procedure being performed.
  2. Male patients at least 18 years of age or older at time of consent.
  3. Histological evidence of adenocarcinoma of the prostate.

  4. Patients must have one of the following documented conditions:

    • Metastatic castration sensitive prostate cancer (mCSPC);
    • Castration sensitive prostate cancer (CSPC) with biochemical relapse (using the Prostate Cancer Working Group 3 [PCWG3] definition of PSA progression) of prostate cancer;
    • Castration sensitive prostate cancer (CSPC) with oligometastatic prostate cancer (e.g., Positron Emission Tomography (PET) positive);
    • Metastatic castration resistant prostate cancer (mCRPC) (only allowed in Phase 1 at the discretion of the Investigator and after a dose cohort that demonstrates adequate suppression of serum testosterone is determined.)
  5. Undergone orchiectomy or ongoing GnRH agonist or antagonist therapy for at least 1 month prior to the Screening Visit, AND a serum testosterone level <50 ng/dL but >2 ng/dL at screening.

Exclusion Criteria:

  1. Metastatic castration resistant prostate cancer (mCRPC) patients more than minimally symptomatic or with a reported pain score on an 11-point (0 - 10) numeric rating scale of >3 over the previous 7 days.
  2. Known active central nervous system (CNS) metastases. Patients 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.

  3. Clinically significant cardiac disease, defined as any of the following:

    • Clinically significant cardiac arrhythmias including bradyarrhythmia and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Subjects with controlled atrial fibrillation are not excluded.
    • Congenital long QT syndrome
    • QTcF ≥450 msec at Screening.
    • History of clinically significant cardiac disease or congestive heart failure >New York Heart Association Class II or left ventricular ejection fraction measurement of <50% at baseline. Subjects 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.
    • Uncontrolled hypertension, defined as systolic blood pressure >160 mmHg or diastolic blood pressure >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).
  4. Prior treatment with abiraterone, orteronel or current treatment with systemic ketoconazole or any other CYP17 inhibitor.
  5. Required concomitant use of strong inducers of CYP3A4 and substrates of CYP2C8 and CYP2D6.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729114


Contacts
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Contact: Tim Warneke, MS 919-397-4782 twarneke@propellatx.com

Locations
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United States, Arizona
Arizona Urology Recruiting
Glendale, Arizona, United States, 85308
Contact: Gladis Solis, RN         
Principal Investigator: Roscoe Nelson, MD         
United States, Indiana
First Urology Recruiting
Jeffersonville, Indiana, United States, 47130
Contact: Debbie Johnson, CCRC         
Principal Investigator: James Bailen, MD         
United States, Maryland
Chesapeake Urology Recruiting
Towson, Maryland, United States, 21204
Contact: Prutha Patel, RN         
Principal Investigator: Ronald Tutrone, MD         
United States, Nebraska
GU Research Recruiting
Omaha, Nebraska, United States, 68130
Contact: Heather Mittelstedt, RN         
Principal Investigator: Luke Nordquist, MD         
United States, New Mexico
Xcancer/NM Oncology Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Inna Lopatuk, RN, MSN         
Principal Investigator: Jose Avitia, MD         
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Jennifer Sutton, RN         
Sponsors and Collaborators
Propella Therapeutics
Investigators
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Study Director: Jackie Walling, MBChB, Ph.D Consulting JW, LLC/Propella Therapeutics
More Information
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Responsible Party: Propella Therapeutics
ClinicalTrials.gov Identifier: NCT04729114    
Other Study ID Numbers: PRL-02-1001
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Propella Therapeutics:
Testosterone
Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases