Fluzoparib and Abiraterone in the preSurgery Treatment of Prostate Cancer: FAST Trial

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this study is to evaluate the safety and efficacy of fluzoparib combined with abiraterone in neoadjuvant treatment of patients with high-risk localized prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Abiraterone Acetate; Androgens; Prednisone

Criteria

Inclusion Criteria:

1. Aged 18 to 75 years;

2. Histologically or cytologically confirmed prostate adenocarcinoma, clinically identified as local according to imaging evaluation, and classified as high-risk or above according to NCCN guidelines;

3. Effective and continuous luteinizing hormone releasing hormone analogue (LHRHa) treatment throughout the study;

4. Serum testosterone >= 150ng/dL;

5. Radical prostatectomy as the main treatment for prostate cancer;

6. Able to understand and willing to sign the informed consent.

Exclusion Criteria:

1. Other malignancies, a history of myelodysplastic syndrome (MDS) / acute myeloid leukemia (AML), or other malignancies within 5 years prior to the first administration of this study (except for cancer in situ with complete remission and malignancies with slow progression determined by the researchers);

2. Received local treatment for prostate cancer (such as radical prostatectomy, radiotherapy and brachytherapy);

3. Previous treated with PARP inhibitor therapy, chemotherapy, mitoxantrone, cyclophosphamide, hormone deprivation therapycpy17 inhibitors, antiandrogens, new endocrine therapy or immunotherapy;

4. Previous treated with strong or moderate intensity CYP3A inhibitors. The washout period was at least 2 weeks before the treatment;

5. Previous treated with strong or moderate intensity CYP3A inducers. The washout period of phenobarbital or enzalutamide was at least 5 weeks, and 3 weeks for other drugs;

6. Habitual drinking grapefruit juice or excessive tea, coffee and/or caffeinated beverages, could not be given up during the trial period;

7. Drugs that may affect P-gp could not be discontinued during the study;

8. Not suitable to participate in this clinical trial judged by researcher for any reason.