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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 : Not yet recruiting
First Posted : January 28, 2021
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Propella Therapeutics

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

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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
Estimated Study Start Date : June 1, 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

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)





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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Undergone orchiectomy or ongoing gonadotropin-releasing hormone agonist or antagonist therapy for at least 3 months prior to the Screening Visit, AND a serum testosterone level <50 ng/dL but >2 ng/dL at screening.
  3. An Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  4. Patients who have documented metastatic castration-sensitive prostate cancer or metastatic castration-resistant prostate cancer , biochemical relapse (using the Prostate Cancer Working Group definition of prostate-specific antigen progression) of prostate cancer or oligometastatic prostate cancer Positron Emission Tomography positive);
  5. Adequate bone marrow reserve defined as:

    • white blood count ≥3,000/µL
    • absolute neutrophil count ≥1,500/µL
    • platelet ≥100,000/µL
    • hemoglobin ≥9 gm/dL
  6. Adequate renal function defined as a serum creatinine of ≤1.5 x the upper limit of normal for the reference lab or a calculated creatinine clearance of ≥50 mL/min as determined by a validated algorithm for calculating creatinine clearance.
  7. Adequate hepatic function, defined as alanine aminotransferase/ aspartate aminotransferase ≤2.5 x the upper limit of normal and total bilirubin ≤1.5 x the upper limit of normal.
  8. Serum albumin of ≥3 gm/dL and serum potassium of ≥3.5 mEq/L.

Exclusion Criteria:

  1. Metastatic castration-resistant prostate cancer patients with hepatic metastases; and/or is more than minimally symptomatic with a reported pain score on an 11-point (0 - 10) numeric rating scale of >3
  2. Known central nervous system (CNS) metastases.
  3. Other active neoplastic disease requiring concurrent anti-neoplastic treatment.
  4. A history of prior myocardial infarction, stroke or transient ischemic attack, or who have uncontrolled inter-current illness, including but not limited to, ongoing or active infection, New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, poorly controlled diabetes, or psychiatric illness/social situations or substance abuse.
  5. Undergone major surgery or trauma within 4 weeks of the Screening Visit.
  6. History of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome).
  7. Need for systemic glucocorticoids greater than replacement doses; the use of topical, intraocular, inhalational, intranasal or intra-articular glucocorticoids is permitted.
  8. Presence of visceral metastatic disease or impending fracture due to bone metastases.

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

Sponsors and Collaborators
Propella Therapeutics
Investigators
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Study Chair: Michael Kurman, MD Propella Therapeutics
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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: March 22, 2021
Last Verified: March 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