Fluzoparib and Abiraterone in the preSurgery Treatment of Prostate Cancer: FAST Trial
Study Details
Study Description
Brief 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. Dr. Yao Zhu from Fudan University Shanghai Cancer Center is the co-leading PI of this study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fluzoparib and abiraterone treatment group Patients would be treated with 1000mg abiraterone qd. Patients would be treated with 150mg fluzoparib bid. Patients would be treated with 5mg prednisone bid. Patients would get medical castration. |
Drug: Abiraterone acetate
Patients would be treated with 1000mg abiraterone qd.
Drug: Fluzoparib
Patients would be treated with 150mg fluzoparib bid.
Drug: Prednisone
Patients would be treated with 5mg prednisone bid.
Drug: Androgen deprivation therapy
Patients would get medical castration.
Procedure: Radical Prostatectomy
Patients would get radical prostatectomy after the neoadjuvant treatment.
|
Outcome Measures
Primary Outcome Measures
- Pathological complete response (pCR) or minimal residual disease (MRD) rate [1 month after prostatectomy as local treatment for primary lesion]
Pathological response, defined as achieving either pCR or MRD at radical prostatectomy (RP). pCR is defined as the absence of morphologically identifiable carcinoma in the RP specimen. MRD will be defined as residual tumor in the RP specimen measuring ≤ 5 mm.
Secondary Outcome Measures
- Biochemical progression-free survival [Up to 2 years]
- Metastasis-free survival [Up to 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged 18 to 75 years;
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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;
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Effective and continuous luteinizing hormone releasing hormone analogue (LHRHa) treatment throughout the study;
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Serum testosterone >= 150ng/dL;
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Radical prostatectomy as the main treatment for prostate cancer;
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Able to understand and willing to sign the informed consent.
Exclusion Criteria:
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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);
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Received local treatment for prostate cancer (such as radical prostatectomy, radiotherapy and brachytherapy);
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Previous treated with PARP inhibitor therapy, chemotherapy, mitoxantrone, cyclophosphamide, hormone deprivation therapycpy17 inhibitors, antiandrogens, new endocrine therapy or immunotherapy;
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Previous treated with strong or moderate intensity CYP3A inhibitors. The washout period was at least 2 weeks before the treatment;
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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;
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Habitual drinking grapefruit juice or excessive tea, coffee and/or caffeinated beverages, could not be given up during the trial period;
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Drugs that may affect P-gp could not be discontinued during the study;
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Not suitable to participate in this clinical trial judged by researcher for any reason.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Shanghai Cancer Center | Shanghai | Shanghai | China | 200000 |
Sponsors and Collaborators
- Fudan University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FAST trial