What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including PARP inhibitors like Fuzuloparib, androgen receptor inhibitors (e.g., enzalutamide, apalutamide), and chemotherapy agents (e.g., docetaxel), have various side effects. PARP inhibitors often cause anemia, nausea, fatigue, and anorexia. Androgen receptor inhibitors can lead to fatigue, seizures (rarely), and gastrointestinal issues such as nausea and diarrhea. Chemotherapy agents like docetaxel are associated with neutropenia, fatigue, diarrhea, and increased risk of infections. These side effects are generally manageable but require monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including PARP inhibitors like Olaparib and Rucaparib, which are used for patients with metastatic castration-resistant prostate cancer (mCRPC) who have specific genetic mutations such as BRCA1/2. These drugs work by inhibiting the PARP enzyme, which helps repair DNA damage in cancer cells, thereby promoting cell death. Other notable treatments include androgen receptor inhibitors like Enzalutamide and Apalutamide, and chemotherapy agents like Docetaxel. These treatments have shown efficacy in improving survival and managing disease progression in prostate cancer patients.

What other types of research exist?

Promising alternatives to Fuzuloparib for prostate cancer patients include Olaparib and Niraparib, both of which have shown efficacy in clinical trials. Additionally, immune checkpoint inhibitors like Pembrolizumab and Dostarlimab are options for patients with specific genetic markers (dMMR or high TMB). Lutetium-177-PSMA-617 is another novel treatment showing promise in recent studies.

← Back to Search

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

Pivotal Trial

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

Select...

I am 18 years old or older.

Select...

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

Select...

My cancer is confirmed as prostate adenocarcinoma.

Select...

My prostate cancer has worsened despite hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My high blood pressure is not under control.

Select...

I have an active heart condition.

Select...

I plan to undergo another cancer treatment.

Select...

I have a history of uncontrolled hormone gland problems.

Select...

I have swallowing problems, chronic diarrhea, or blockages that affect how I absorb medication.

Select...

I have been treated with a PARP inhibitor before.

Select...

I have received treatment for prostate cancer after it spread.

Select...

I have tumors in my brain confirmed by scans.

Select...

I cannot take Prednisone due to health reasons.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

ORR

Time to PSA progression

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 13Eligibility criteria met

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.