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

Primary Purpose

High-risk Prostate Cancer, Neoadjuvant Therapy

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Abiraterone acetate

Fluzoparib

Prednisone

Androgen deprivation therapy

Radical Prostatectomy

About this trial

This is an interventional treatment trial for High-risk Prostate Cancer focused on measuring Prostate cancer, Neoadjuvant therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Aged ≥18 years;
Histologically or cytologically confirmed prostate adenocarcinoma, clinically identified as regional disease (pelvic lymph node metastasis only) according to imaging evaluation, or localized disease(classified as high-risk or above according to NCCN guidelines);
Effective and continuous luteinizing hormone releasing hormone analogue (LHRHa) treatment throughout the study;
Serum testosterone >= 150ng/dL;
Radical prostatectomy as the main treatment for prostate cancer;
Able to understand and willing to sign the informed consent.

Exclusion Criteria:

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);
Received local treatment for prostate cancer (such as radical prostatectomy, radiotherapy and brachytherapy);
Previous treated with PARP inhibitor therapy, chemotherapy, mitoxantrone, cyclophosphamide, hormone deprivation therapycpy17 inhibitors, antiandrogens, new endocrine therapy or immunotherapy;
Previous treated with strong or moderate intensity CYP3A inhibitors. The washout period was at least 2 weeks before the treatment;
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;
Habitual drinking grapefruit juice or excessive tea, coffee and/or caffeinated beverages, could not be given up during the trial period;
Drugs that may affect P-gp could not be discontinued during the study;
Not suitable to participate in this clinical trial judged by researcher for any reason.

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluzoparib and abiraterone treatment group

Arm Description

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.

Outcomes

Primary Outcome Measures

Pathological complete response (pCR) or minimal residual disease (MRD) rate

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

Metastasis-free survival

Full Information

NCT ID

NCT05223582

First Posted

January 10, 2022

Last Updated

October 6, 2022

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT05223582

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2021 (Actual)

Primary Completion Date

May 1, 2023 (Anticipated)

Study Completion Date

May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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 locoregional prostate cancer. Dr. Yao Zhu from Fudan University Shanghai Cancer Center is the co-leading PI of this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High-risk Prostate Cancer, Neoadjuvant Therapy

Keywords

Prostate cancer, Neoadjuvant therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fluzoparib and abiraterone treatment group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Abiraterone acetate

Intervention Description

Patients would be treated with 1000mg abiraterone qd.

Intervention Type

Drug

Intervention Name(s)

Fluzoparib

Intervention Description

Patients would be treated with 150mg fluzoparib bid.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Patients would be treated with 5mg prednisone bid.

Intervention Type

Drug

Intervention Name(s)

Androgen deprivation therapy

Intervention Description

Patients would get medical castration.

Intervention Type

Procedure

Intervention Name(s)

Radical Prostatectomy

Intervention Description

Patients would get radical prostatectomy after the neoadjuvant treatment.

Primary Outcome Measure Information:

Title

Pathological complete response (pCR) or minimal residual disease (MRD) rate

Description

Time Frame

1 month after prostatectomy as local treatment for primary lesion

Secondary Outcome Measure Information:

Title

Biochemical progression-free survival

Time Frame

Up to 2 years

Title

Metastasis-free survival

Time Frame

Up to 2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged ≥18 years; Histologically or cytologically confirmed prostate adenocarcinoma, clinically identified as regional disease (pelvic lymph node metastasis only) according to imaging evaluation, or localized disease(classified as high-risk or above according to NCCN guidelines); Effective and continuous luteinizing hormone releasing hormone analogue (LHRHa) treatment throughout the study; Serum testosterone >= 150ng/dL; Radical prostatectomy as the main treatment for prostate cancer; Able to understand and willing to sign the informed consent. Exclusion Criteria: 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); Received local treatment for prostate cancer (such as radical prostatectomy, radiotherapy and brachytherapy); Previous treated with PARP inhibitor therapy, chemotherapy, mitoxantrone, cyclophosphamide, hormone deprivation therapycpy17 inhibitors, antiandrogens, new endocrine therapy or immunotherapy; Previous treated with strong or moderate intensity CYP3A inhibitors. The washout period was at least 2 weeks before the treatment; 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; Habitual drinking grapefruit juice or excessive tea, coffee and/or caffeinated beverages, could not be given up during the trial period; Drugs that may affect P-gp could not be discontinued during the study; Not suitable to participate in this clinical trial judged by researcher for any reason.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yao Zhu, doctor

Phone

+8602164175590

med_wangbh@163.com

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beihe Wang, doctor

Phone

+8602164175590

med_wangbh@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The IPD could shared for scientific purpose by contacting the PI via email.

Learn more about this trial

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

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