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ONC-392 + Lutetium for Prostate Cancer (PRESERVE-006 Trial)
Phase 1 & 2
Recruiting
Led By Mark Stein, MD
Research Sponsored by OncoC4, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
PRESERVE-006 Trial Summary
This trial tests a new combination of treatments for metastatic prostate cancer. Participants are randomized to two arms to assess safety and effectiveness.
Who is the study for?
This trial is for adults with metastatic prostate cancer resistant to castration who've progressed on androgen receptor inhibitors, have had prior taxane treatments (up to two), and show a positive PSMA PET/CT scan. They should be in good health overall, with an ECOG score of 0 or 1, adequate organ function, and no other recent cancers or severe illnesses.Check my eligibility
What is being tested?
The study tests ONC-392 combined with lutetium Lu 177 vipivotide tetraxetan against standard care using only lutetium Lu 177. Patients are randomly assigned in a 2:1 ratio to either receive both drugs together or just the standard treatment to see if the combination improves survival without disease progression.See study design
What are the potential side effects?
Potential side effects may include reactions related to infusion, changes in blood counts leading to increased infection risk or bleeding problems, kidney issues due to radiation exposure from lutetium Lu 177 vipivotide tetraxetan, fatigue, nausea, and possibly immune-related adverse events.
PRESERVE-006 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic progression free survival (rPFS)
Secondary outcome measures
Overall response rate (ORR)
TEAE, TRAE and irAE
PRESERVE-006 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: ONC-392 plus lutetium Lu 177 vipivotide tetraxetanExperimental Treatment2 Interventions
Arm A receives ONC-392, IV infusion, for up to 9 doses, plus lutetium Lu 177 vipivotide tetraxetan IV infusion, Q6W for up to 6 doses.
Group II: lutetium Lu 177 vipivotide tetraxetanActive Control1 Intervention
lutetium Lu 177 vipivotide tetraxetan, IV infusion, Q6W for up to 6 doses.
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Who is running the clinical trial?
OncoC4, Inc.Lead Sponsor
6 Previous Clinical Trials
1,620 Total Patients Enrolled
Prostate Cancer Clinical Trials ConsortiumOTHER
10 Previous Clinical Trials
7,094 Total Patients Enrolled
8 Trials studying Prostate Cancer
7,034 Patients Enrolled for Prostate Cancer
Mark Stein, MDPrincipal InvestigatorColumbia University
8 Previous Clinical Trials
332 Total Patients Enrolled
4 Trials studying Prostate Cancer
113 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from side effects of previous cancer treatments.I have at least one cancer spread that shows on scans taken within the last 28 days.I have been treated with medications like enzalutamide or abiraterone.I am not on more than 10 mg/day of prednisone or any immunosuppressive medication.I haven't had certain radiation treatments in the last 6 months.I have symptoms from cancer spreading to my brain or spinal cord.My organs are functioning well.My heart doesn't work properly.I have an autoimmune disease or am taking immunosuppressive drugs.I am fully active or can carry out light work.My prostate cancer has spread and was confirmed by a lab test.I have been treated with 1 or 2 taxane-based therapies before.My prostate cancer is worsening despite treatment.I have an active gastrointestinal condition like ulcers or IBD.I have undergone treatment to lower my testosterone due to prostate cancer.I have not used any cancer treatments or participated in any clinical trials within the last 28 days.I haven't had cancer treatment for another type of cancer in the last 2 years.I do not have any active infections.I am 18 years or older and can sign a consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: ONC-392 plus lutetium Lu 177 vipivotide tetraxetan
- Group 2: lutetium Lu 177 vipivotide tetraxetan
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 opportunities to take part in this research initiative currently?
"As per the information found on clinicaltrials.gov, this study is not presently seeking participants for its research. The trial was initially posted September 1st 2023 and has most recently been updated July 11th of that same year. Despite this particular experiment being at capacity, a total of 1267 other studies are currently recruiting patients."
Answered by AI
How many facilities are currently participating in the trial?
"This research is being conducted jointly by XCancer/GU Research Network in Omaha, Nebraska; NYU Langone Health and Laura & Isaac Perlmutter Cancer Center both located in New york City; as well as Duke University Medical Centre - Duke Cancer Center based out of Durham, North carolina alongside 6 other clinical locations."
Answered by AI
What risks have been found to accompany Arm A: ONC-392 10 mg/kg, Q4W plus lutetium Lu 177 vipivotide tetraxetan 7.4 GBq, Q6W for human subjects?
"Based on the information available, our team at Power has determined that Arm A: ONC-392 10 mg/kg, Q4W plus lutetium Lu 177 vipivotide tetraxetan 7.4 GBq, Q6W can be rated with a score of 2 due to existent data confirming its safety yet lacking evidence for efficacy."
Answered by AI
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