AzTrials
AzTrials

High-risk Prostate CancerPhase 2NCT05223582

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

A Phase 2 study testing Abiraterone acetate, Fluzoparib and Prednisone in people with High-risk Prostate Cancer and Neoadjuvant Therapy, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Abiraterone acetate, Fluzoparib and Prednisone
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
1 May 2021to Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old.
  • Patients must have histologically or cytologically confirmed prostate adenocarcinoma, clinically assessed as localized or with only pelvic lymph node metastasis according to radiological evaluation, and categorized as high- or very-high risk per the National Comprehensive Cancer Network (NCCN) guidelines.
  • Patients need to maintain effective luteinizing hormone-releasing hormone analogue (LHRHa) therapy throughout the study treatment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
  • Males choosing radical prostatectomy as the primary treatment for prostate cancer.
  • Normal bone marrow function: Absolute neutrophil count ≥ 1.5×10^9/L; platelets ≥ 100×10^9/L; hemoglobin ≥ 90g/L; white blood cell count ≥ 3.6×10^9/L.
Show all 13Show fewer
  • Normal liver function: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 ULN (upper limit of normal), total bilirubin ≤ 1.5 times ULN, Child-Pugh Class A, serum albumin ≥ 3g/dL.
  • Normal coagulation function: International normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 ULN, prothrombin time (PT) < ULN + 4 seconds.
  • Normal cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; QTc < 450ms for males, < 470ms for females, blood potassium ≥ 3.5mmol/L.
  • Normal blood pressure: Systolic blood pressure < 160mmHg, diastolic blood pressure < 95mmHg, patients with normal blood pressure after appropriate clinical treatment can be included.
  • Normal kidney function: Serum creatinine ≤ 1.5 ULN, creatinine clearance ≥ 50 mL/min.
  • Patients deemed to have the ability to ejaculate and an active sexual life must agree to use effective contraception and not to donate sperm from the first administration of the study drug until 3 months after the last administration.
  • Patients are able to understand and willing to sign the informed consent form. Patients are able to comply with the study visit schedule and other protocol requirements.

Who cannot join

  • Patients with a history of other malignant tumors, myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML), or who have had other malignant tumors within 5 years before the first dosa (excluding completely resolved in situ cancers and malignancies deemed by the investigator to progress slowly).
  • Patients who have undergone local treatment for prostate cancer (such as radical prostatectomy, radiotherapy, or brachytherapy).
  • Patients who have received radiotherapy or major surgery within 3 weeks before the first dose or participated in another drug clinical trial within 4 weeks before the first dose.
  • Patients planning to receive any other antitumor therapy during the study treatment.
  • Patients who have received treatment with PARP inhibitors (e.g., fluzoparib, olaparib, talazoparib, veliparib, niraparib, lucaparib, or others), chemotherapy (e.g., docetaxel, cisplatin, carboplatin, oxaliplatin, or others), mitoxantrone, cyclophosphamide, CYP17 inhibitors such as ketoconazole, conventional anti-androgen therapy (luteinizing hormone-releasing hormone [LHRH] agonists/antagonists, bicalutamide, nilutamide), novel hormonal therapy (e.g., abiraterone, enzalutamide, apalutamide), or immunotherapy (e.g., sipuleucel-T vaccine, ipilimumab). Patients who have received conventional anti-androgen therapy or abiraterone for no more than 1 month are allowed to enroll.
  • Patients who have previous treated with strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, ritonavir, cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The washout period before the first dose should be at least 2 weeks.
Show all 22Show fewer
  • Patients who have previous treated with strong CYP3A inducers (e.g., phenobarbital, phenytoin, rifampin, rifabutin, rifapentine, carbamazepine, nevirapine) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The washout period before the first dose should be at least 5 weeks for phenobarbital or enzalutamide and 3 weeks for other drugs.
  • Habitual drinking grapefruit juice or excessive tea, coffee, and/or caffeine-containing beverages, which cannot be discontinued during the study.
  • Inability to discontinue the use of medications that may affect P-glycoprotein (P-gp) during the study, including but not limited to amiodarone, carvedilol, clarithromycin, delavirdine, erythromycin, lapatinib, lopinavir, nelfinavir, propranolol, quinidine, ranolazine, tipranavir, and verapamil.
  • Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases, active or symptomatic viral hepatitis, or chronic liver disease (HBV viral load ≥ 10^4 copies/mL, HCV viral load ≥ 10^3 copies/mL).
  • Clinically significant heart disease, such as New York Heart Association (NYHA) Class III-IV heart failure, myocardial infarction within the past 6 months, severe or unstable angina, or recent ventricular arrhythmias.
  • Preexisting duodenal stents or any gastrointestinal disorder or defect that the investigator believes would interfere with drug absorption.
  • Habitual constipation or diarrhea, irritable bowel syndrome, or inflammatory bowel disease; intra-abdominal fistula, gastrointestinal perforation, or abdominal abscess within the past 6 months, requiring blood transfusion for gastrointestinal bleeding.
  • Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting medication intake and absorption.
  • History of asthma induced by nonsteroidal anti-inflammatory drugs (NSAIDs) or classified as "mild persistent" or more severe asthma history (symptoms ≥ 2 days per week).
  • History of uncontrolled pituitary or adrenal dysfunction, existing gonadal dysfunction, or severe hypogonadism.
  • Contraindications to the use of prednisone (corticosteroids) such as active infections or other lesions.
  • Any chronic disease requiring corticosteroid therapy at doses exceeding "prednisone 5mg, twice daily."
  • Allergy or intolerance to the active ingredients of fluzoparib, abiraterone, or prednisone.
  • History of neurological and psychiatric disorders such as dementia, epilepsy, or seizure susceptibility.
  • According to the investigator's judgment, there are severe concurrent diseases (such as severe diabetes, thyroid disease, and psychiatric illness, etc.) or unstable medical, psychological, or other conditions (including laboratory abnormalities) that may pose a serious risk to the subject's safety, affect the subject's completion of the study, or affect the study protocol and follow-up schedule.
  • Unsuitable for participation in this clinical trial for any reason according to the investigator's judgment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

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.

Being tested
Abiraterone acetate, Fluzoparib, Prednisone, Androgen deprivation therapy, Radical Prostatectomy
Keywords
Prostate cancer, Neoadjuvant therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone acetateDrug

    Patients would be treated with 1000mg abiraterone qd.

  • FluzoparibDrug

    Patients would be treated with 150mg fluzoparib bid.

  • PrednisoneDrug

    Patients would be treated with 5mg prednisone bid.

  • Androgen deprivation therapyDrug

    Patients would get medical castration.

  • Radical ProstatectomyProcedure or surgery

    Patients would get radical prostatectomy after the neoadjuvant treatment.

Study groups in NCT05223582
Study groupRoleWhat they receive
Fluzoparib and abiraterone treatment groupExperimentalPatients 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.
Receives: Drug: Abiraterone acetate; Drug: Fluzoparib; Drug: Prednisone; Drug: Androgen deprivation therapy; Procedure: Radical Prostatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month after prostatectomy as local treatment for primary lesion

Secondary outcomes (7)

  1. Biochemical progression-free survival

    Measured: Up to 2 years

  2. Metastasis-free survival

    Measured: Up to 2 years

  3. PSA responses

    Measured: During the treatment

  4. surgical margins

    Measured: 1 month after prostatectomy as local treatment for primary lesion

  5. pathological stage

    Measured: 1 month after prostatectomy as local treatment for primary lesion

  6. radiological responses

    Measured: 1 week before prostatectomy as local treatment for primary lesion

  7. safety

    Measured: During the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2022
  2. Study start1 May 2021
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05223582
Sponsor's protocol ID
FAST trial
Status last verified
Dec 2023
First submitted
10 Jan 2022
Last updated
8 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The IPD could be shared for scientific purposes by contacting the PI via email.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone acetate, Fluzoparib and Prednisone in people with High-risk Prostate Cancer and Neoadjuvant Therapy, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) or minimal residual disease (MRD) rate (time frame: 1 month after prostatectomy as local treatment for primary lesion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05223582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in