Metastatic Castration-resistant Prostate CancerPhase 2PARTOMNCT06971211
Radiotherapy Combined With Fluzopanib and Abiraterone Acetate Tablets (II) Treatment for mCRPC
A Phase 2 study testing Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone. in people with Metastatic Castration-resistant Prostate Cancer, run by Jianbin Bi at 1 site in China.
Trial summary
This study is an open label, single arm, multicenter clinical trial. The aim of this study is to evaluate the efficacy, safety, and quality of life of radiotherapy combined with Fuzuloparib and Abiraterone Acetate Tablets（Ⅱ） as first-line treatment for castration resistant prostate cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2024to 30 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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, male
- ECOG score is 0 or 1
- Untreated first-line metastatic castration resistant prostate cancer patients
- Allow the use of a new endocrine drug treatment once during hormone sensitive stages
- The organ function level must meet the following requirements (no blood transfusion or hematopoietic growth factor therapy received within 2 weeks before blood routine screening): ANC ≥ 1.5 × 109/L PLT≥100×109/L； • Hb≥90 g/L； • TBIL ≤ 1.5 × ULN (excluding subjects with Gilbert syndrome) • ALT and AST ≤ 2.5 × ULN; • Cr≤1.5×ULN； • LVEF≥50%； • QTcF≤450 ms。
- If the partner is a subject with fertility, they should undergo surgical sterilization or agree to receive it during and at the end of the trial period
- Sign a written informed consent form and expect good compliance with the research protocol
Who cannot join
- Previously received any PARPi treatment for prostate cancer (including but not limited to Olaparib, Nilaparib, Terazopanib, Lucaparib, etc.)
- Other clinical trial drug treatments and major surgeries received within the 4 weeks prior to randomization in this study
- There are factors such as inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect medication intake and absorption
- Have a history of epilepsy or have experienced a disease that can trigger epileptic seizures within the 12 months prior to randomization (including a history of transient ischemic attacks, stroke, traumatic brain injury with consciousness disorders requiring hospitalization)
- Active heart disease within the first 6 months of randomization, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure (heart function class III or IV), and drug-induced ventricular arrhythmias
- Individuals with active HBV and HCV infection (HBsAg positive and virus copy number ≥ 500 IU/mL, HCV antibody positive and HCV RNA above the detection limit of the analytical method)
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- Individuals with a known history of allergies to Fluzopanib and Abiraterone nanocrystals and their components
- Individuals with a history of congenital immunodeficiency or organ transplantation, or HIV positive subjects who meet one or more of the following criteria: Not receiving highly effective antiretroviral therapy; Change antiretroviral therapy within 6 months prior to the start of screening; • Undertaking antiretroviral therapy that may interfere with the investigational drug (please consult the sponsor before enrollment); CD4 count<350/mm3 during screening; Opportunistic infections that meet the definition of acquired immunodeficiency syndrome occurred within the 12 months prior to the start of screening
- Patients with other malignant tumors within the past 3 years prior to randomization (excluding in situ cancer that has completely resolved and malignant tumors judged by researchers to have slow progression)
- The researchers determined that participants with ejaculation ability and sexual activity were unwilling to take the contraceptive measures specified in the protocol during the entire study treatment period and within 3 months after the last dose
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Liping Zhou, Doctor, 86+ 13898195001, zhouliping750825@163.com
About this study
Official title: An Open, Single Arm, Multicenter Clinical Study on the First-line Treatment of Metastatic Castration Resistant Prostate Cancer With Radiotherapy Combined With Fuzuloparib and Abiraterone Acetate Tablets（Ⅱ）
This study is an open label, single arm, multicenter clinical trial. The aim of this study is to evaluate the efficacy, safety, and quality of life of radiotherapy combined with Fuzuloparib and Abiraterone Acetate Tablets（Ⅱ） as first-line treatment for castration resistant prostate cancer patients. The study aims to enroll 40 eligible subjects with PSA response rate (PSA 50) as the primary endpoint.
Read the detailed description
This study is an open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy, safety, and quality of life of first-line treatment with the combination of radiotherapy, fluzoparib, abiraterone acetate (II) for patients with metastatic castration-resistant prostate cancer (mCRPC).Eligible subjects who meet the inclusion criteria will be enrolled and assessed for Homologous Recombination Repair (HRR) mutation status. Participants will undergo two phases of treatment: the induction phase and the maintenance phase. During the induction phase, patients will receive Intensity-Modulated Radiation Therapy (IMRT) in combination with fluzoparib, abiraterone acetate (II), and prednisone. In the maintenance phase, patients will continue treatment with fluzoparib, abiraterone acetate (II), and prednisone. Each treatment cycle is 28 days long, and treatment will continue until disease progression is determined by the investigator and the patient is no longer clinically benefiting from the study. Follow-up will continue until the subject withdraws informed consent or the study ends, whichever occurs first.The study plans to enroll 40 eligible subjects. The primary endpoint is the PSA response rate (the proportion of patients with a ≥50% decrease in PSA from baseline). Secondary endpoints include radiographic progression-free survival (rPFS), time to PSA progression (TTPP), PSA depth of response (PSA 90, PSA undetectable rate), time to first subsequent treatment (TFST), failure-free survival (FFS), and overall survival (OS).
- Being tested
- Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone.
- Keywords
- prostate cancer, fuzuloparib, abiraterone acetate, Intensity modulated radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone.Drug
Also called Treatment group
Induction therapy, fluzoparib (150mg BID orally), abiraterone acetate tablets (II) (300mg QD orally), and prednisone (5mg BID orally). IMRT was administered as follows: For patients with low metastatic burden tumors: Prostate ± pelvic lymph node radiation + metastatic lesion radiation.For patients with non-low metastatic burden tumors: Prostate±pelvic lymph node radiation.IMRT dosage:Prostate: 70 Gy in 28 fractions (2.5 Gy/fraction, 5 fractions per week).Pelvic lymph nodes: 50.4 Gy in 28 fractions (1.8 Gy/fraction, 5 fractions per week).Fluzoparib and abiraterone acetate (II) were administered concurrently with radiotherapy. Maintenance treatment,patients received the same doses of fluzoparib,abiraterone acetate (II), and prednisone. Each treatment cycle lasted 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Induction therapy,patients were treated with intensity-modulated radiation therapy (IMRT) combined with fluzoparib,abiraterone acetate tablets (II), and prednisone. Maintenance treatment,patients received the same doses of fluzoparib,abiraterone acetate (II), and prednisone. Each treatment cycle lasted 28 days. Receives: Drug: Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA relief rate
The proportion of patients who achieve a ≥50% reduction in serum PSA levels compared to baseline.
Measured: The duration from the first day of patient enrollment to the time when PSA decreases by ≥ 50% compared to baseline should not exceed 12 months.
Secondary outcomes (6)
Radiographic Progression-free survival（rPFS）
From the first day of patient enrollment to the time of imaging progression or death. Imaging progress includes the discovery of at least 2 new lesions under bone scanning (based on the definition of PCWG-3), or measurable soft tissue lesions under computed tomography (CT) or magnetic resonance imaging (MRI) (based on the definition of RECIST 1.1). According to the RECIST 1.1 guidelines, progression requires a 20% increase in the sum of all target lesion diameters, and an absolute minimum sum increase of 5 millimeters (mm) compared to the sum of the lowest values
Measured: The duration of evaluation from the first day of patient enrollment to the time of radiological progression should not exceed 60 months.
Time To PSA Progression（TTPP）
To determine the progression time of prostate-specific antigen (PSA), according to the PCWG3 standard, PSA progression is defined as an increase in PSA level by ≥ 25% and an absolute value of ≥ 2µg/L (2ng/mL) compared to the lowest PSA level observed after or at baseline, and confirmed during the second consecutive test at least 3 weeks later。
Measured: The duration of evaluation from the first day of patient enrollment to the time of PSA progression should not exceed 60 months.
PSA deep relief rate
The proportion of patients who achieve a ≥90% reduction in PSA levels from baseline and have a minimum PSA value of ≤0.2 ng/ml after enrollment.
Measured: The duration from the first day of patient enrollment to the time when PSA decreases by ≥ 90% from baseline and the lowest PSA value is ≤ 0.2ng/ml should not exceed 12 months.
Time To First Subsequent Therapy（TFST）
The time period between the enrollment date and the date of initiation of subsequent tumor treatment.
Measured: The duration from the first day of patient enrollment to the start of any subsequent prostate cancer treatment should not exceed 60 months.
Failure-free Survival（FFS）
From enrollment until the first occurrence of documented local or regional recurrence, distant metastasis, or death from any cause, with the earliest event taking precedence. Failure-free survival is assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.for any reason, whichever occurs first. Failure free survival evaluation based on the evaluation criteria for solid tumor treatment efficacy (RECIST V1.1)
Measured: The duration of evaluation from the first day of patient enrollment to any degree of disease progression should not exceed 60 months.
Overall survival（OS）
Overall survival is defined as the time from the first day of enrollment to the patient's death due to any cause.
Measured: The duration from the first day of patient enrollment to all-cause mortality rate should not exceed 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start27 Nov 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianbin Bi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianbin Bi, First Hospital of China Medical University
- Investigators
- Jianbin Bi, Doctor, Study director, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971211
- Sponsor's protocol ID
- FirstHCMU-JBi-PARTOM
- Acronym
- PARTOM
- Status last verified
- May 2025
- First submitted
- 18 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single Arm, Multicenter Clinical Study on the First-line Treatment of Metastatic Castration Resistant Prostate Cancer With Radiotherapy Combined With Fuzuloparib and Abiraterone Acetate Tablets（Ⅱ）
- ClinicalTrials.gov ID
- NCT06971211
- Acronym / sponsor ID
- PARTOM / FirstHCMU-JBi-PARTOM
- Keywords
- prostate cancer, fuzuloparib, abiraterone acetate, Intensity modulated radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jianbin BiUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open label, single arm, multicenter clinical trial. The aim of this study is to evaluate the efficacy, safety, and quality of life of radiotherapy combined with Fuzuloparib and Abiraterone Acetate Tablets（Ⅱ） as first-line treatment for castration resistant prostate cancer patients. The study aims to enroll 40 eligible subjects with PSA response rate (PSA 50) as the primary endpoint.
Detailed description
This study is an open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy, safety, and quality of life of first-line treatment with the combination of radiotherapy, fluzoparib, abiraterone acetate (II) for patients with metastatic castration-resistant prostate cancer (mCRPC).Eligible subjects who meet the inclusion criteria will be enrolled and assessed for Homologous Recombination Repair (HRR) mutation status. Participants will undergo two phases of treatment: the induction phase and the maintenance phase. During the induction phase, patients will receive Intensity-Modulated Radiation Therapy (IMRT) in combination with fluzoparib, abiraterone acetate (II), and prednisone. In the maintenance phase, patients will continue treatment with fluzoparib, abiraterone acetate (II), and prednisone. Each treatment cycle is 28 days long, and treatment will continue until disease progression is determined by the investigator and the patient is no longer clinically benefiting from the study. Follow-up will continue until the subject withdraws informed consent or the study ends, whichever occurs first.The study plans to enroll 40 eligible subjects. The primary endpoint is the PSA response rate (the proportion of patients with a ≥50% decrease in PSA from baseline). Secondary endpoints include radiographic progression-free survival (rPFS), time to PSA progression (TTPP), PSA depth of response (PSA 90, PSA undetectable rate), time to first subsequent treatment (TFST), failure-free survival (FFS), and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone.Induction therapy,patients were treated with intensity-modulated radiation therapy (IMRT) combined with fluzoparib,abiraterone acetate tablets (II), and prednisone. Maintenance treatment,patients received the same doses of fluzoparib,abiraterone acetate (II), and prednisone. Each treatment cycle lasted 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old, male
- ECOG score is 0 or 1
- Untreated first-line metastatic castration resistant prostate cancer patients
- Allow the use of a new endocrine drug treatment once during hormone sensitive stages
- The organ function level must meet the following requirements (no blood transfusion or hematopoietic growth factor therapy received within 2 weeks before blood routine screening): ANC ≥ 1.5 × 109/L PLT≥100×109/L； • Hb≥90 g/L； • TBIL ≤ 1.5 × ULN (excluding subjects with Gilbert syndrome) • ALT and AST ≤ 2.5 × ULN; • Cr≤1.5×ULN； • LVEF≥50%； • QTcF≤450 ms。
Key exclusion criteria (10 listed)
- Previously received any PARPi treatment for prostate cancer (including but not limited to Olaparib, Nilaparib, Terazopanib, Lucaparib, etc.)
- Other clinical trial drug treatments and major surgeries received within the 4 weeks prior to randomization in this study
- There are factors such as inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect medication intake and absorption
- Have a history of epilepsy or have experienced a disease that can trigger epileptic seizures within the 12 months prior to randomization (including a history of transient ischemic attacks, stroke, traumatic brain injury with consciousness disorders requiring hospitalization)
- Active heart disease within the first 6 months of randomization, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure (heart function class III or IV), and drug-induced ventricular arrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone.Also: Treatment groupInduction therapy, fluzoparib (150mg BID orally), abiraterone acetate tablets (II) (300mg QD orally), and prednisone (5mg BID orally). IMRT was administered as follows: For patients with low metastatic burden tumors: Prostate ± pelvic lymph node radiation + metastatic lesion radiation.For patients with non-low metastatic burden tumors: Prostate±pelvic lymph node radiation.IMRT dosage:Prostate: 70 Gy in 28 fractions (2.5 Gy/fraction, 5 fractions per week).Pelvic lymph nodes: 50.4 Gy in 28 fractions (1.8 Gy/fraction, 5 fractions per week).Fluzoparib and abiraterone acetate (II) were administered concurrently with radiotherapy. Maintenance treatment,patients received the same doses of fluzoparib,abiraterone acetate (II), and prednisone. Each treatment cycle lasted 28 days. | Drug | Cohort 1 |
Primary outcome
PSA relief rate
Time frame: The duration from the first day of patient enrollment to the time when PSA decreases by ≥ 50% compared to baseline should not exceed 12 months.
The proportion of patients who achieve a ≥50% reduction in serum PSA levels compared to baseline.
6 secondary outcomes
Radiographic Progression-free survival（rPFS）
Time frame: The duration of evaluation from the first day of patient enrollment to the time of radiological progression should not exceed 60 months.
Time To PSA Progression（TTPP）
Time frame: The duration of evaluation from the first day of patient enrollment to the time of PSA progression should not exceed 60 months.
PSA deep relief rate
Time frame: The duration from the first day of patient enrollment to the time when PSA decreases by ≥ 90% from baseline and the lowest PSA value is ≤ 0.2ng/ml should not exceed 12 months.
Time To First Subsequent Therapy（TFST）
Time frame: The duration from the first day of patient enrollment to the start of any subsequent prostate cancer treatment should not exceed 60 months.
Failure-free Survival（FFS）
Time frame: The duration of evaluation from the first day of patient enrollment to any degree of disease progression should not exceed 60 months.
Overall survival（OS）
Time frame: The duration from the first day of patient enrollment to all-cause mortality rate should not exceed 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianbin Bi, Doctor study director
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone. in people with Metastatic Castration-resistant Prostate Cancer, run by Jianbin Bi 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 14 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianbin Bi, Doctor (86+ 13998227296, jianbinbi@cmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA relief rate (time frame: The duration from the first day of patient enrollment to the time when PSA decreases by ≥ 50% compared to baseline should not exceed 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2025.