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Radiopharmaceutical

Peposertib for Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By Hiram A Gay
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Progression after at least one of the following: abiraterone, enzalutamide, apalutamide, darolutamide, or taxane chemotherapy (docetaxel, cabazitaxel). There is no maximum number of prior therapies. Prior immunotherapies (for example, Sipuleucel-T or pembrolizumab) do not exclude the patient from participation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of randomization to date of scan showing either skeletal or extraskeletal progression following prostate cancer clinical trials working group 3 methodology or death, assessed up to 2 years
Awards & highlights

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.

Eligible Conditions
  • Castration-resistant Prostate Cancer
  • Lymph Node Cancer
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of randomization to date of scan showing either skeletal or extraskeletal progression following prostate cancer clinical trials working group 3 methodology or death, assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and date of randomization to date of scan showing either skeletal or extraskeletal progression following prostate cancer clinical trials working group 3 methodology or death, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicity (Phase 1)
Radiographic progression free survival (rPFS) (Phase 2)
Secondary outcome measures
Incidence of toxicity and adverse events
Overall survival (OS)
PFS
+1 more
Other outcome measures
Biomarker analysis
Quality of life

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (radium-223 dichloride, nedisertib, avelumab)Experimental Treatment5 Interventions
Patients receive radium-223 dichloride IV as in Arm A and peposertib PO QD or BID as in Arm B. Patients also receive avelumab IV over 60 minutes on days 1 and 15 of cycles 2-6. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (radium-223 dichloride)Active Control3 Interventions
Patients receive radium-223 dichloride IV over 1 minute on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group III: Arm B (radium-223 dichloride, nedisertib)Active Control4 Interventions
Patients receive radium-223 dichloride as in Arm A and peposertib PO or BID on days 3-26. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peposertib
2021
Completed Phase 1
~20
Radium Ra 223 Dichloride
2017
Completed Phase 2
~90
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,556 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,154 Patients Enrolled for Prostate Cancer
Hiram A GayPrincipal InvestigatorYale University Cancer Center LAO
Jeff M MichalskiPrincipal InvestigatorYale University Cancer Center LAO

Media Library

Radium-223 Dichloride (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04071236 — Phase 1 & 2
Prostate Cancer Research Study Groups: Arm C (radium-223 dichloride, nedisertib, avelumab), Arm A (radium-223 dichloride), Arm B (radium-223 dichloride, nedisertib)
Prostate Cancer Clinical Trial 2023: Radium-223 Dichloride Highlights & Side Effects. Trial Name: NCT04071236 — Phase 1 & 2
Radium-223 Dichloride (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04071236 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~18 spots leftby Jan 2025