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Study Summary
This trial is testing a new drug to find the best dose for safety and effectiveness.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Awards & Highlights
Trial Design
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Who is running the clinical trial?
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- You have a performance status of 0 or 1.You have cancer that has spread to your brain, or a history of seizures.You are currently receiving treatment for cancer.You have received at least one treatment in the past for metastatic castration-resistant prostate cancer (mCRPC).You have received treatment before for metastatic castration-resistant prostate cancer.You have measurable or evaluable disease.You are allergic to the study drug JNJ-80038114 or its ingredients.You have serious infections or medical conditions affecting your lungs, heart, or other parts of your body.
- Group 1: Part 1: Dose Escalation
- Group 2: Part 2: Dose Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are any Canadian healthcare institutions currently testing this therapy?
"Patients for this medical study can be recruited from the Sidney Kimmel Cancer Center - Jefferson Health in Philadelphia, Pennsylvania, University Of Minnesota in Minneapolis, Minnesota and Sarah Cannon Research Institute in Nashville, Tennesseef Minnesota in Minneapolis, Minnesota and Sarah Cannon Research Institute in Nashville, Tennessee as well as 4 other research sites."
What is the primary aim of this medical investigation?
"The funder of this research trial, Janssen Research & Development, LLC has identified a primary objective to be observed over the course of up to 2 Years and 6 Months: The Number of Participants With AEs by Severity. Additionally, secondary objectives such as Serum Concentration of JNJ-80038114, Prostate Specific Antigen (PSA) Concentration, and Objective Response Rate (ORR), will also be tracked in order to accurately assess outcomes."
How many participants is this clinical trial recruiting?
"Absolutely. According to the information accessible on clinicaltrials.gov, this medical trial was first posted on November 15th 2022 and is actively seeking participants. The research requires 110 volunteers from 4 different sites in order to continue its progress."
Does this research endeavor still accept participants at this time?
"Affirmative. The clinical trial, which was first opened on November 15th 2022, is actively recruiting patients as indicated by the data hosted on clinicaltrials.gov. A total of 110 participants must be recruited from 4 separate centres for this study to proceed."
Has the Food and Drug Administration cleared JNJ-80038114 to be used medicinally?
"As JNJ-80038114 is currently in its initial trials, the safety of this medication is only tentatively established. Thus, it has been assigned a score of 1 out of 3."
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