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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone. | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PSA relief rate | The proportion of patients who achieve a ≥50% reduction in serum PSA levels compared to baseline. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianbin Bi, Doctor | Contact | 86+ 13998227296 | jianbinbi@cmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianbin Bi, Doctor | First Hospital of China Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
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| 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。 | 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. | 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. | 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) | 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. | The duration from the first day of patient enrollment to all-cause mortality rate should not exceed 60 months. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| C000722917 | fluzoparib |
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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