Metastatic Castration Resistant Prostate CancerPhase 2NCT04869488
A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer
A Phase 2 study testing Fluzoparib, Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets and Fluzoparib Combined With Apatinib in people with Metastatic Castration Resistant Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Main research purpose: To evaluate the effectiveness of Fluzoparib combined with apatinib mesylate in the treatment of patients with metastatic castration-resistant prostate cancer. 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?
- Fluzoparib, Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets and Fluzoparib Combined With Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2021to 14 Feb 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
- Voluntary participation and written informed consent;
- Age ≥18 years old;
- Pathologically diagnosed metastatic castration-resistant prostate adenocarcinoma;
- It is confirmed by the central laboratory based on tumor tissue or ctDNA detection that it is accompanied by germline or system homologous recombination repair-related gene mutations (Cohorts 4) or not accompanied by homologous recombination repair-related gene mutations (Cohort 2);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Has a life expectancy of ≥ 12 weeks.
Who cannot join
- Past (within 5 years) or concurrently suffering from other malignant tumors, except for cured skin basal cell carcinoma;
- Subjects have used PARP inhibitors in the past, including but not limited to olaparib, niraparib, and lukapanib; or have used apatinib in the past; or have received mitoxantrone and cyclophosphamide in the past Treatment with amide or platinum-containing chemotherapeutics;
- Severe bone injury caused by tumor bone metastasis, pathological fractures or spinal cord compression in important parts that occurred within 6 months before being informed or is expected to occur in the near future;
- The subject has cancerous meningitis, or untreated central nervous system metastasis;
- Those who cannot swallow pills normally, or have abnormal gastrointestinal function, which may affect drug absorption by the researcher;
- Subjects with congenital or acquired immune deficiencies (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥500 IU/ml; hepatitis C reference: HCV antibody positive and HCV virus copy number> upper limit of normal );
- According to the judgment of the investigator, the subject has other factors that may cause the study to be terminated halfway, such as other serious diseases (including mental illness) that require combined treatment, severe laboratory abnormalities, family or society, etc. Factors that will affect the safety of subjects or the collection of data and samples.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200433
About this study
Official title: An Open, Multi-center, Phase Ⅱ Clinical Study of Fluzoparib Combined With Apatinib or Fluzoparib in the Treatment of Metastatic Castration-resistant Prostate Cancer
Main research purpose: To evaluate the effectiveness of Fluzoparib combined with apatinib mesylate in the treatment of patients with metastatic castration-resistant prostate cancer.
- Being tested
- Fluzoparib, Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets, Fluzoparib Combined With Apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
Fluzoparib Orally twice daily（Cohort 1、Cohort 4）
Enzalutamide OR abiraterone acetate With Prednisone Acetate TabletsDrug
Enzalutamide OR abiraterone acetate Orally once daily（Cohort 1）
Fluzoparib Combined With ApatinibDrug
Fluzoparib Orally twice daily; Apatinib Orally once daily（Cohort 2、Cohort 3、Cohort 4）
| Study group | Role | What they receive |
|---|---|---|
| Fluzoparib | Experimental | Not described Receives: Drug: Fluzoparib |
| Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets | Active comparator | Not described Receives: Drug: Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets |
| Fluzoparib Combined With Apatinib | Experimental | Not described Receives: Drug: Fluzoparib Combined With Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive response rate
Comprehensive remission rate means the proportion of objective remission or PSA remission evaluated by the investigator based on the RECIST v1.1 standard and the PCWG3 standard
Measured: up to 2 years
Secondary outcomes (5)
Radiological progression-free survival (rPFS)
The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
Measured: up to 2 years
Objective response rate (ORR)
ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)).
Measured: At the time point of every 8 weeks，up to 2 years
PSA response rate
PSA response rate was Defined as the proportion of subjects whose serum PSA level decreased by ≥50% from baseline after treatment.
Measured: At the time point of every 4 weeks，up to 2 years
Time to PSA progression (PSA-TTP)
PSA-TTP was defined as the time from random (cohort 1 and 4) or first medication (cohort 2 and 3) to the first progression of PSA; PSA progression is determined according to the PCWG3 standard, and changes in PSA levels within the 12 weeks before treatment (that is, before C4D1) are not included in this Evaluation.
Measured: At the time point of every 4 weeks，up to 2 years
Overall Survival (OS)
Number of Participants with Overall Survival (OS)
Measured: At the time point of every 2 months，up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start19 Jul 2021
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
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.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fluzopali in combination with apatinib mesylate or fluzopali monotherapy with or without homologous recombinant repair-related gene mutations in metastatic castration-resistant prostate in subjects
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869488
- Sponsor's protocol ID
- SHR3162-Ⅱ-202
- Status last verified
- Jan 2025
- First submitted
- 26 Apr 2021
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multi-center, Phase Ⅱ Clinical Study of Fluzoparib Combined With Apatinib or Fluzoparib in the Treatment of Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04869488
- Acronym / sponsor ID
- SHR3162-Ⅱ-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 3 May 2021 (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.
Main research purpose: To evaluate the effectiveness of Fluzoparib combined with apatinib mesylate in the treatment of patients with metastatic castration-resistant prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Fluzopali in combination with apatinib mesylate or fluzopali monotherapy with or without homologous recombinant repair-related gene mutations in metastatic castration-resistant prostate in subjects
| Arm | Type | Receives |
|---|---|---|
| Fluzoparib | Experimental | Drug: Fluzoparib |
| Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets | Active comparator | Drug: Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets |
| Fluzoparib Combined With Apatinib | Experimental | Drug: Fluzoparib Combined With Apatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary participation and written informed consent;
- Age ≥18 years old;
- Pathologically diagnosed metastatic castration-resistant prostate adenocarcinoma;
- It is confirmed by the central laboratory based on tumor tissue or ctDNA detection that it is accompanied by germline or system homologous recombination repair-related gene mutations (Cohorts 4) or not accompanied by homologous recombination repair-related gene mutations (Cohort 2);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Key exclusion criteria (7 listed)
- Past (within 5 years) or concurrently suffering from other malignant tumors, except for cured skin basal cell carcinoma;
- Subjects have used PARP inhibitors in the past, including but not limited to olaparib, niraparib, and lukapanib; or have used apatinib in the past; or have received mitoxantrone and cyclophosphamide in the past Treatment with amide or platinum-containing chemotherapeutics;
- Severe bone injury caused by tumor bone metastasis, pathological fractures or spinal cord compression in important parts that occurred within 6 months before being informed or is expected to occur in the near future;
- The subject has cancerous meningitis, or untreated central nervous system metastasis;
- Those who cannot swallow pills normally, or have abnormal gastrointestinal function, which may affect drug absorption by the researcher;
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 |
|---|---|---|
| FluzoparibFluzoparib Orally twice daily（Cohort 1、Cohort 4） | Drug | Fluzoparib |
| Enzalutamide OR abiraterone acetate With Prednisone Acetate TabletsEnzalutamide OR abiraterone acetate Orally once daily（Cohort 1） | Drug | Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets |
| Fluzoparib Combined With ApatinibFluzoparib Orally twice daily; Apatinib Orally once daily（Cohort 2、Cohort 3、Cohort 4） | Drug | Fluzoparib Combined With Apatinib |
Primary outcome
Comprehensive response rate
Time frame: up to 2 years
Comprehensive remission rate means the proportion of objective remission or PSA remission evaluated by the investigator based on the RECIST v1.1 standard and the PCWG3 standard
5 secondary outcomes
Radiological progression-free survival (rPFS)
Time frame: up to 2 years
Objective response rate (ORR)
Time frame: At the time point of every 8 weeks，up to 2 years
PSA response rate
Time frame: At the time point of every 4 weeks，up to 2 years
Time to PSA progression (PSA-TTP)
Time frame: At the time point of every 4 weeks，up to 2 years
Overall Survival (OS)
Time frame: At the time point of every 2 months，up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Castration Resistant Prostate Cancer
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NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 1/2
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Fluzoparib, Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets and Fluzoparib Combined With Apatinib in people with Metastatic Castration Resistant Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 24 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comprehensive response rate (time frame: up to 2 years). 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 24 Jan 2025.