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Hormone Therapy

Fuzuloparib + AA-P for Prostate Cancer

Phase 3

Recruiting

Research Sponsored by Jiangsu HengRui Medicine Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age of ≥ 18 years old

A score of 0 to 1 for ECOG performance status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial is testing whether a new drug, Fuzuloparib, is better than a placebo at treating mCRPC (a type of cancer) when used with another drug, AA-P. The trial will enroll two groups of subjects, one group that has not been tested for DRD status and one group that has been tested for DRD status.

Who is the study for?

Men over 18 with advanced prostate cancer that's worsened despite hormone therapy can join. They must be fairly healthy, able to consent, and provide blood and tumor samples for DNA repair deficiency testing. Excluded are those with HIV, hepatitis B or C, brain tumors, heart disease, certain digestive issues or who've had prior PARP inhibitors or recent strong drug interactions.Check my eligibility

What is being tested?

The study tests if adding Fuzuloparib to standard treatment (Abiraterone acetate and Prednisone) is better than a placebo plus the standard treatment in slowing down cancer growth. It includes two groups: one where patients' cancers have specific DNA repair issues and another without these issues.See study design

What are the potential side effects?

Fuzuloparib may cause nausea, fatigue, anemia (low red blood cell count), potential heart problems among others. Abiraterone can lead to high blood pressure, fluid retention and liver function changes while Prednisone might cause weight gain, mood swings and increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am fully active or have some restrictions but can still care for myself.

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My cancer is confirmed as prostate adenocarcinoma.

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My prostate cancer has worsened despite hormone therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3

Secondary outcome measures

ORR

Time to PSA progression

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment group AExperimental Treatment1 Intervention

Fuzuloparib plus AA-P

Group II: Treatment group BPlacebo Group1 Intervention

Fuzuloparib Placebo plus AA-P

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jiangsu HengRui Medicine Co., Ltd.Lead Sponsor

627 Previous Clinical Trials

94,128 Total Patients Enrolled

5 Trials studying Prostate Cancer

912 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04691804 — Phase 3

Frequently Asked Questions

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

In how many different medical facilities is this research project being conducted today?

"In addition to the three primary sites of Johns Hopkins in Baltimore, Maryland, VA Maryland Health Care System in Baton Rouge, Louisiana, and Hematology Oncology Clinic in Jacksonville, Florida, this trial is also being conducted at 15 other medical facilities."

Answered by AI

Are there any other ongoing or completed research projects that include these three drugs?

"Currently, there are 392 ongoing clinical trials for the combination of Fuzuloparib , Abiraterone acetate and Prednisone. 105 of those studies are in Phase 3. Although most of the trials for this treatment are based in Duarte, California, there are a total of 17209 locations running these studies."

Answered by AI

How large is the sample size for this clinical research?

"In order to complete this study, 804 individuals that fit the pre-determined criteria must enroll. This research is being conducted out of various locations, such as Johns Hopkins in Baltimore, Maryland and VA Maryland Health Care System in Baton Rouge, Louisiana."

Answered by AI

To what degree do Fuzuloparib, Abiraterone acetate and Prednisone increase patient risk?

"Fuzuloparib , Abiraterone acetate and Prednisone have been studied enough that their safety can be reasonably estimated; they received a 3."

Answered by AI

What are the FDA-approved indications for Fuzuloparib , Abiraterone acetate and Prednisone?

"Fuzuloparib , Abiraterone acetate and Prednisone can all help ameliorate the symptoms of thyroiditis, ulcerative colitis, and malignant neoplasms."

Answered by AI

Are we still looking for volunteers for this experiment?

"The answer is affirmative, the listing on clinicaltrials.gov suggests that this experiment needs more volunteers and is currently looking for 804 individuals. The original posting was on March 18th, 2021 with the latest update being from July 28th, 2022. There are 15 different facilities where this trial is taking place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer

2021. "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04691804.

All > Prostate Cancer Anaheim > Abiraterone Acetate