Fuzuloparib , Abiraterone acetate and Prednisone for Metastatic Castration Resistant Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Metastatic Castration Resistant Prostate CancerFuzuloparib , Abiraterone acetate and Prednisone - Drug
Eligibility
18+
Male
What conditions do you have?
Select

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.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: up to 4 years

up to 3 years
ORR
Time to PSA progression
rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3
up to 4 years
OS
Time to skeletal-related events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Treatment group A
1 of 2
Treatment group B
1 of 2

Experimental Treatment

Non-Treatment Group

804 Total Participants · 2 Treatment Groups

Primary Treatment: Fuzuloparib , Abiraterone acetate and Prednisone · Has Placebo Group · Phase 3

Treatment group A
Drug
Experimental Group · 1 Intervention: Fuzuloparib , Abiraterone acetate and Prednisone · Intervention Types: Drug
Treatment group B
Drug
PlaceboComparator Group · 1 Intervention: Fuzuloparib Placebo, Abiraterone acetate and Prednisone · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years

Who is running the clinical trial?

Jiangsu HengRui Medicine Co., Ltd.Lead Sponsor
556 Previous Clinical Trials
84,151 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
is indicative of good performance status A 0 to 1 score on the ECOG performance status scale indicates good performance status.
The disease progressed rapidly in the subject while he was on androgen deprivation therapy.
on needle biopsy The patient has been diagnosed with prostate adenocarcinoma after a needle biopsy was performed.
of the activities of the organism The organs in an organism must have a level of functionality that meets the requirements of the activities that the organism undertakes.
to includemake me a research participant I am able to and willing to provide a written informed consent to include me as a research participant.
An individual who is 18 years of age or older.
Blood and tumor tissue samples are provided during screening to determine the DRD status.