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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04729114
• Other study ID #: PRL-02-1001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 14, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2024
• Source: Astellas Pharma Inc
• Contact: Astellas Pharma Global Development, Inc.
• Phone: 800-888-7704
• Email: Astellas.registration[@]astellas.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• mCRPC
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• PRL-02 injection
abiraterone decanoate for intramuscular injection
• prednisone
5 mg once daily or twice daily
• dexamethasone
0.5 mg administered once daily
• docetaxel infusion
docetaxel administered via intravenous infusion

Locations

Country	Name	City	State
United States	New Mexico Oncology Hematology Consultants Ltd	Albuquerque	New Mexico
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	Duke Cancer Center	Durham	North Carolina
United States	First Urology	Jeffersonville	Indiana
United States	Helios Clinical Research, LLC	Middleburg Heights	Ohio
United States	Garden Sate Urology	Morristown	New Jersey
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Associates PC	Nashville	Tennessee
United States	XCancer Center Omaha/Urology Cancer Center	Omaha	Nebraska
United States	Urology San Antonio	San Antonio	Texas
United States	Toledo Clinical Cancer Center	Toledo	Ohio
United States	Chesapeake Urology	Towson	Maryland
United States	Wichita Urology Group	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (adverse events)	Determine the incidence rates for adverse events using NCI CTCAE v5.0 grading through study completion, an average of 1 year	Treatment
Primary	Determination of recommended Phase 2 dose (RP2D)	Select RP2D of PRL-02 depot by evaluation of safety parameters up to 84 days	Treatment
Secondary	Evaluate pharmacokinetics (PK) profile of PRL-02	Determination of PK profiles of PRL-02 up to 84 days	Treatment