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Fluzoparib and Abiraterone in the preSurgery Treatment of Prostate Cancer

A phase II clinical study of fluzoparib combined with abiraterone in neoadjuvant treatment of hormone sensitive prostate cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046198
Enrollment
Unknown
Registered
2021-05-09
Start date
2021-05-07
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Caner

Interventions

Experimental Group:fluzoparib+abiraterone

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged =18 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.Radical prostatectomy as the main treatment for prostate cancer; 5.Able to understand and willing to sign the informed consent.

Exclusion criteria

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 (excluding previous antiandrogens or abiraterone treatment for no more than one month); 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.

Design outcomes

Primary

MeasureTime frame
Pathological remission rate;

Secondary

MeasureTime frame
Biochemical progression free survival;Metastasis free survival;

Countries

China

Contacts

Public ContactYe Dingwei, Zhu Yao

Fudan university Shanghai Cancer Cente

dwyeli_uro@163.com+86 21 6417 5590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026