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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 15, 2021
First Posted Date  ICMJE January 28, 2021
Last Update Posted Date July 20, 2021
Actual Study Start Date  ICMJE June 14, 2021
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2021)
Safety and tolerability [ Time Frame: Treatment ]
Reporting of number of patients with adverse events related to study drug
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer
Official Title  ICMJE Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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)

Study Arms  ICMJE
  • Experimental: Cohort 1
    The starting dose will be 180 mg of PRL-02 depot (abiraterone decanoate for intramuscular injection)
    Intervention: Drug: abiraterone decanoate
  • Experimental: Cohort 2
    Cohort 2 dose will be 360 mg of PRL-02 depot (abiraterone decanoate for intramuscular injection)
    Intervention: Drug: abiraterone decanoate
  • Experimental: Cohort 3
    Cohort 3 dose will be 720 mg of PRL-02 depot (abiraterone decanoate for intramuscular injection)
    Intervention: Drug: abiraterone decanoate
  • Experimental: Cohort 4
    Cohort 4 dose will be 1260 mg of PRL-02 depot (abiraterone decanoate for intramuscular injection)
    Intervention: Drug: abiraterone decanoate
  • 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.
    Intervention: Drug: abiraterone decanoate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2021)
33
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2021)
45
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tim Warneke, MS 919-397-4782 twarneke@propellatx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04729114
Other Study ID Numbers  ICMJE PRL-02-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Propella Therapeutics
Study Sponsor  ICMJE Propella Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jackie Walling, MBChB, Ph.D Consulting JW, LLC/Propella Therapeutics
PRS Account Propella Therapeutics
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP