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PRL-02 Injection for Prostate Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Propella Therapeutics
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment
Awards & highlights
Study Summary
This trial is testing a new drug for prostate cancer that is given as a shot.
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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My prostate cancer is sensitive or resistant to hormone therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of recommended Phase 2 dose (RP2D)
Safety (adverse events)
Secondary outcome measures
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
~9860
Find a Location
Who is running the clinical trial?
Propella TherapeuticsLead Sponsor
2 Previous Clinical Trials
242 Total Patients Enrolled
Jackie Walling, MBChB, Ph.DStudy DirectorConsulting JW, LLC/Propella Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases but am stable after treatment and not on high-dose steroids.I am fully active or restricted in physically strenuous activity but can do light work.I have had surgery to remove my testicles or have been on hormone therapy for over a month.My prostate cancer is sensitive or resistant to hormone therapy.I am allergic to PRL-02, abiraterone, prednisone, dexamethasone, or their ingredients.I have not taken estrogen in the last 3 months.I have prostate cancer and no other cancers needing treatment, except for certain skin cancers or cancers I've been free of for 5+ years.I am not currently on any AR blocking agents or have stopped them as required before starting PRL-02.I need high doses of steroids, not just for replacement.I have not had chemotherapy within the last 2 weeks.I am taking medication that strongly affects liver enzyme levels.You are severely overweight with a body mass index greater than 40 kg/m^2.I have a serious heart condition.I have taken abiraterone or enzalutamide and my cancer has gotten worse.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Expansion Group D
- Group 2: Cohort 5
- Group 3: Phase 1 Expansion Group E
- Group 4: Phase 2a Dose Expansion Group F1
- Group 5: Phase 2a Dose Expansion Group F2
- Group 6: Phase 2a Dose Expansion Group G
- Group 7: Cohort 3
- Group 8: Cohort 1
- Group 9: Cohort 2
- Group 10: Cohort 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies for participants in this medical experiment?
"Affirmative. Clinicaltrials.gov reveals that this medical experiment, which was first unveiled on June 14th 2021, is actively seeking participants for enrolment. Nine clinical sites are in need of 100 volunteers to complete the study."
Answered by AI
How many participants are currently being evaluated in this research?
"To properly conduct this trial, 100 willing and eligible patients need to sign up. Potential participants can join from Urology Associates PC in Nashville or Chesapeake Urology in Towson, Maryland."
Answered by AI
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