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PRL-02 Injection for Prostate Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) of 0 or 1
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)
Must not have
Known hypersensitivity to PRL-02, abiraterone, abiraterone decanoate, prednisone, or dexamethasone or any of their excipients or components.
Received chemotheapy within 2 weeks or 5 half-lives of Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment
Awards & highlights

Summary

This trial tests a muscle injection called PRL-02 for patients with advanced prostate cancer. It aims to slowly release the medication to help manage the disease.

Who is the study for?
This trial is for men with advanced prostate cancer, including various stages and those who've had hormone therapy. Participants should be relatively fit (ECOG 0 or 1) and may have received certain other treatments like abiraterone or enzalutamide. Men with severe obesity, active heart disease, known allergies to the drugs being tested, uncontrolled diabetes, brain metastases not stable post-treatment, recent chemotherapy, current AR blockers use or estrogens in the last 3 months can't join.
What is being tested?
The study tests PRL-02 injections along with standard medications like prednisone and dexamethasone in men with advanced prostate cancer. It's an early-phase trial to see how well this new treatment works when given as a shot into the muscle. Some patients will also receive docetaxel infusions.
What are the potential side effects?
Possible side effects include reactions at the injection site for PRL-02; increased blood sugar levels from steroids like prednisone and dexamethasone; fatigue, nausea, hair loss from docetaxel infusion; plus general risks of infection due to immune system impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My prostate cancer is sensitive or resistant to hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to PRL-02, abiraterone, prednisone, dexamethasone, or their ingredients.
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I have not had chemotherapy within the last 2 weeks.
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I am taking medication that strongly affects liver enzyme levels.
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I have a serious heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determination of recommended Phase 2 dose (RP2D)
Safety (adverse events)
Secondary study objectives
Evaluate pharmacokinetics (PK) profile of PRL-02

Trial Design

10Treatment groups
Experimental Treatment
Group I: Phase 2a Dose Expansion Group GExperimental Treatment2 Interventions
Dosing at RP2D; mCRPC
Group II: Phase 2a Dose Expansion Group F2Experimental Treatment2 Interventions
Dosing at RP2D; low volume mCSPC
Group III: Phase 2a Dose Expansion Group F1Experimental Treatment3 Interventions
Dosing at recommended Phase 2 dose (RP2D); high volume mCSPC
Group IV: Phase 1 Expansion Group EExperimental Treatment2 Interventions
Prior enzalutamide, apalutamide and/or darolutamide
Group V: Phase 1 Expansion Group DExperimental Treatment2 Interventions
Prior abiraterone
Group VI: Cohort 5Experimental Treatment3 Interventions
1800 mg PRL-02 + dexamethasone or prednisone
Group VII: Cohort 4Experimental Treatment3 Interventions
1260 mg PRL-02 + dexamethasone or prednisone
Group VIII: Cohort 3Experimental Treatment3 Interventions
720 mg PRL-02 + dexamethasone or prednisone
Group IX: Cohort 2Experimental Treatment3 Interventions
360 mg PRL-02 + dexamethasone or prednisone
Group X: Cohort 1Experimental Treatment3 Interventions
180 mg PRL-02 + dexamethasone or prednisone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
prednisone
1999
Completed Phase 3
~10920
dexamethasone
1995
Completed Phase 3
~9520

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer, such as androgen deprivation therapy (ADT), work by reducing androgen levels or blocking androgen receptors, which are essential for the growth of prostate cancer cells. Novel agents, including PARP inhibitors and immune checkpoint inhibitors, target specific genetic mutations or boost the immune system's ability to fight cancer. These mechanisms are crucial for personalizing treatment plans based on a patient's unique genetic makeup and disease features, potentially leading to better outcomes and fewer side effects.

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
199 Previous Clinical Trials
122,577 Total Patients Enrolled
7 Trials studying Prostate Cancer
5,076 Patients Enrolled for Prostate Cancer
Propella TherapeuticsLead Sponsor
2 Previous Clinical Trials
242 Total Patients Enrolled
Central ContactStudy DirectorAstellas Pharma Global Development, Inc.
99 Previous Clinical Trials
6,397,387 Total Patients Enrolled
4 Trials studying Prostate Cancer
882 Patients Enrolled for Prostate Cancer

Media Library

abiraterone decanoate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04729114 — Phase 1 & 2
Prostate Cancer Research Study Groups: Phase 1 Expansion Group D, Cohort 5, Phase 1 Expansion Group E, Phase 2a Dose Expansion Group F1, Phase 2a Dose Expansion Group F2, Phase 2a Dose Expansion Group G, Cohort 3, Cohort 1, Cohort 2, Cohort 4
Prostate Cancer Clinical Trial 2023: abiraterone decanoate Highlights & Side Effects. Trial Name: NCT04729114 — Phase 1 & 2
abiraterone decanoate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04729114 — Phase 1 & 2
~7 spots leftby Dec 2024
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