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Peposertib for Prostate Cancer
Study Summary
This trial is testing a new drug, M3814, to see if it can help treat prostate cancer that has spread to other parts of the body and is no longer responsive to hormonal therapy. M3814 will be given alone or in combination with other drugs, and the goal is to see if it can lower the chances of the cancer growing or spreading.
- Castration-resistant Prostate Cancer
- Lymph Node Cancer
- Prostate Cancer
Eligibility Criteria
Inclusion Criteria
You may 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.Trial Design
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Who is running the clinical trial?
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- You have tried at least one of the following treatments: abiraterone, enzalutamide, apalutamide, darolutamide, or taxane chemotherapy (docetaxel, cabazitaxel) and your condition has worsened. The number of previous treatments doesn't matter. Previous immunotherapies like Sipuleucel-T or pembrolizumab do not disqualify you from participating.
- Group 1: Arm C (radium-223 dichloride, nedisertib, avelumab)
- Group 2: Arm A (radium-223 dichloride)
- Group 3: Arm B (radium-223 dichloride, nedisertib)
- 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
What precedent has been set by prior research utilizing Peposertib?
"At present, 115 studies are underway to analyse the efficacy of Peposertib with 10 being at Phase 3. Though many can be found in Houston, Texas, a total of 3699 clinical trial sites across the globe are researching this medication."
Is recruitment for this research project still underway?
"Affirmative. Clinicaltrials.gov has evidence that this study is presently accepting participants, after having been posted on December 26th 2019 and last updated on November 30th 2022. The trial requires 90 individuals from 21 separate medical centres."
What aims does this clinical trial hope to fulfill?
"The primary goal of this 28-day trial is to assess radiographic progression free survival (rPFS). Secondary objectives include progression free survival, symptomatic skeletal events, and the incidence rate of adverse reactions. Assessments will be performed using Kaplan–Meier estimates with accompanying confidence intervals, log rank tests as well as univariate and multivariate Cox models for rPFS. Toxicities are evaluated based on CTCAE version 5.0 standards."
Is this the initial research of its kind to be conducted?
"At present, 115 trials involving Peposertib are ongoing worldwide in 1,024 cities and 52 countries. This drug's clinical trial journey began in 2014 with a Phase 2 study sponsored by EMD Serono Research & Development Institute Inc., which included 204 participants. In the six years since then, 282 studies have been completed."
How many facilities are managing this investigation?
"The clinical trial is operational in 21 locations, such as Emory University Hospital/Winship Cancer Institute based out of Dallas, the Emory Saint Joseph's Hospital located in Fairway, and UT Southwestern/Simmons Cancer Center-Dallas from Lexington. Additionally, there are 18 more sites offering this medical intervention."
What is the aggregate amount of individuals participating in this experiment?
"Affirmative. According to records on clinicaltrials.gov, this trial is presently searching for participants and was initially posted in December of 2019 with its most recent update taking place at the end of November 2022. The recruitment process involves 90 volunteers from 21 distinct sites."
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