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

March 7, 2024 updated by: Propella Therapeutics

Phase 1/2a, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer

A Phase 1/2a, open-label, multicenter study of intramuscular (i.m.) PRL-02 depot in participants with advanced prostate cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Phase 1/2a, open-label, multicenter study of intramuscular (i.m.) PRL-02 depot in participants with castration-sensitive prostate cancer (CSPC) and metastatic castration-resistant prostate cancer (mCRPC). In Phase 1 (Dose Escalation), participants will receive escalating doses of i.m. PRL-02 in 84-day treatment cycles combined with daily oral steroid.

In Phase 2a (Dose Expansion), participants with metastatic castration-sensitive prostate cancer (mCSPC) and mCRPC will receive i.m. PRL-02 at one or more recommended Phase 2 doses (RP2Ds) selected from Phase 1 in 84-day treatment cycles in combination with dexamethasone and docetaxel (Group F1) or in combination with dexamethasone (Groups F2, G). In both phases, participants will undergo scheduled periodic assessments of prostate specific antigen (PSA), testosterone and progesterone levels in the blood.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • Recruiting
        • First Urology
        • Contact:
          • Debbie Johnson, CCRC
        • Principal Investigator:
          • James Bailen, MD
    • Kansas
      • Wichita, Kansas, United States, 67226
    • Maryland
      • Towson, Maryland, United States, 21204
        • Recruiting
        • Chesapeake Urology
        • Contact:
          • Erica Boroshok
        • Principal Investigator:
          • Ronald Tutrone, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • XCancer Center Omaha/Urology Cancer Center
        • Principal Investigator:
          • Luke Nordquist, MD
        • Contact:
    • New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • New Mexico Oncology Hematology Consultants Ltd
        • Contact:
          • Sarah Tellez
        • Principal Investigator:
          • Jose Avitia, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center
        • Contact:
    • Ohio
      • Miamisburg, Ohio, United States, 45342
        • Recruiting
        • Clinical Research Solutions
        • Contact:
      • Toledo, Ohio, United States, 43623
        • Not yet recruiting
        • Toledo Clinical Cancer Center
        • Contact:
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • MidLantic Urology
        • Principal Investigator:
          • Laurence M Belkoff
        • Contact:
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center
        • Contact:
        • Principal Investigator:
          • Neal D Shore, MD, FACS
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates PC
        • Contact:
        • Principal Investigator:
          • David S Morris
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Urology San Antonio
        • Contact:
          • Clara De La Cruz
          • Phone Number: 210-617-4116
        • Principal Investigator:
          • Jose De La Cerda, MD
        • Contact:
          • Emily Robb
          • Phone Number: 210-617-4116
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Not yet recruiting
        • University of Virginia Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histological evidence of adenocarcinoma of the prostate, including metastatic castration sensitive prostate cancer (mCSPC); castration sensitive prostate cancer (CSPC); castration sensitive prostate cancer (CSPC); metastatic castration resistant prostate cancer (mCRPC)
  • Undergone bilateral orchiectomy or ongoing GnRH agonist or antagonist therapy for at least 6 weeks prior to the first dose of study drug which must be continued throughout the study
  • Eastern Cooperative Oncology Group (ECOG) of 0 or 1
  • For Phase1 expansion Groups D & E only, received prior darolutamide, apalutamide, abiraterone or enzalutamide and have documented evidence of progression

Exclusion Criteria:

  • Known active central nervous system (CNS) metastases, except those who have been treated with surgery and/or radiation therapy, who are off pharmacologic doses of glucocorticoids, and who are neurologically stable.
  • Known additional malignancy beyond prostate cancer that required active treatment with the exception of: 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 patient is currently in remission and has been in remission for ≥2 years; any other cancer from which the patient has been disease-free for ≥5 years
  • Clinically significant cardiac disease
  • Received chemotherapy within 2 weeks or 5 half-lives of first dose of study drug
  • Current treatment with enzalutamide, flutamide, nilutamide, bicalutamide, or any other androgen receptor (AR) blocking agents. Patients who have received anti-androgens or AR blocking agents must have discontinued bicalutamide ≥6 weeks and other antiandrogens ≥4 weeks prior to the first dose of PRL-02.
  • Prior treatment with estrogens within 12 weeks of the first dose of study drug
  • Need for systemic glucocorticoids greater than replacement doses; the use of topical, intraocular, inhalational, intranasal, or intra-articular glucocorticoids is permitted.
  • Required concomitant use of strong inducers of CYP3A4.
  • Known hypersensitivity to PRL-02, abiraterone, abiraterone decanoate, prednisone, or dexamethasone or any of their excipients or components.
  • Hemoglobin A1c (HbA1c) >10% in patients previously diagnosed with diabetes mellitus. HbA1c >8% in patients whose diabetes mellitus is previously undiagnosed. (Excluded patients may be rescreened after referral and evidence of improved control of their condition).
  • Body mass index > 40 kg/m^2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 Expansion Group D
Prior abiraterone
Drug: dexamethasone
0.5 mg administered once daily
Drug: PRL-02 injection
abiraterone decanoate for intramuscular injection
Experimental: Phase 2a Dose Expansion Group F1
Dosing at recommended Phase 2 dose (RP2D); high volume mCSPC
Drug: dexamethasone
0.5 mg administered once daily
Drug: PRL-02 injection
abiraterone decanoate for intramuscular injection
Drug: docetaxel infusion
docetaxel administered via intravenous infusion
Experimental: Phase 2a Dose Expansion Group F2
Dosing at RP2D; low volume mCSPC
Drug: dexamethasone
0.5 mg administered once daily
Drug: PRL-02 injection
abiraterone decanoate for intramuscular injection
Experimental: Phase 2a Dose Expansion Group G
Dosing at RP2D; mCRPC
Drug: dexamethasone
0.5 mg administered once daily
Drug: PRL-02 injection
abiraterone decanoate for intramuscular injection
Experimental: Cohort 1
180 mg PRL-02 + dexamethasone or prednisone
Drug: dexamethasone
0.5 mg administered once daily
Drug: PRL-02 injection
abiraterone decanoate for intramuscular injection
Drug: prednisone
5 mg once daily or twice daily
Experimental: Cohort 2
360 mg PRL-02 + dexamethasone or prednisone
Drug: dexamethasone
0.5 mg administered once daily
Drug: PRL-02 injection
abiraterone decanoate for intramuscular injection
Drug: prednisone
5 mg once daily or twice daily
Experimental: Cohort 3
720 mg PRL-02 + dexamethasone or prednisone
Drug: dexamethasone
0.5 mg administered once daily
Drug: PRL-02 injection
abiraterone decanoate for intramuscular injection
Drug: prednisone
5 mg once daily or twice daily
Experimental: Cohort 4
1260 mg PRL-02 + dexamethasone or prednisone
Drug: dexamethasone
0.5 mg administered once daily
Drug: PRL-02 injection
abiraterone decanoate for intramuscular injection
Drug: prednisone
5 mg once daily or twice daily
Experimental: Cohort 5
1800 mg PRL-02 + dexamethasone or prednisone
Drug: dexamethasone
0.5 mg administered once daily
Drug: PRL-02 injection
abiraterone decanoate for intramuscular injection
Drug: prednisone
5 mg once daily or twice daily
Experimental: Phase 1 Expansion Group E
Prior enzalutamide, apalutamide and/or darolutamide
Drug: dexamethasone
0.5 mg administered once daily
Drug: PRL-02 injection
abiraterone decanoate for intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (adverse events)
Time Frame: Treatment
Determine the incidence rates for adverse events using NCI CTCAE v5.0 grading through study completion, an average of 1 year
Treatment
Determination of recommended Phase 2 dose (RP2D)
Time Frame: Treatment
Select RP2D of PRL-02 depot by evaluation of safety parameters up to 84 days
Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate pharmacokinetics (PK) profile of PRL-02
Time Frame: Treatment
Determination of PK profiles of PRL-02 up to 84 days
Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Propella Therapeutics

Investigators

  • Study Director: Jackie Walling, MBChB, Ph.D, Consulting JW, LLC/Propella Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRL-02-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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