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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
Must not have
Uncontrolled hypertension
Presence of active heart diseases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Summary

This trial is testing whether a combination of Fuzuloparib and AA-P is better for treating advanced prostate cancer. The treatment aims to kill cancer cells by preventing them from fixing their damaged DNA and by reducing hormone levels that help the cancer grow. The study includes patients with and without specific DNA repair deficiencies.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My high blood pressure is not under control.
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I have an active heart condition.
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I plan to undergo another cancer treatment.
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I have a history of uncontrolled hormone gland problems.
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I have swallowing problems, chronic diarrhea, or blockages that affect how I absorb medication.
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I have been treated with a PARP inhibitor before.
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I have received treatment for prostate cancer after it spread.
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I have tumors in my brain confirmed by scans.
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I cannot take Prednisone due to health reasons.

Timeline

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
OS
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer include androgen receptor signaling inhibitors like enzalutamide and abiraterone, and PARP inhibitors such as Fuzuloparib. Androgen receptor signaling inhibitors work by blocking the binding of androgens to their receptors, inhibiting the receptor's movement to the cell nucleus, and preventing the receptor from interacting with DNA. This is crucial because prostate cancer cells often rely on androgen signaling for growth and survival. PARP inhibitors, on the other hand, target cancer cells with deficiencies in DNA repair mechanisms, such as those with homologous recombination repair (HRR) deficiencies. By inhibiting PARP enzymes, these drugs prevent cancer cells from repairing their DNA, leading to cell death. These mechanisms are vital for prostate cancer patients as they offer targeted approaches to disrupt cancer cell growth and survival, potentially leading to better treatment outcomes.
Horizon scanning for novel therapeutics for the treatment of prostate cancer.

Find a Location

Who is running the clinical trial?

Jiangsu HengRui Medicine Co., Ltd.Lead Sponsor
643 Previous Clinical Trials
98,123 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,012 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04691804 — Phase 3
~315 spots leftby Dec 2026
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