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New treatment option for Metastatic Castration-resistant Prostate Cancer
Official title Radiotherapy Combined With Fluzopanib and Abiraterone Acetate Tablets (II) Treatment for mCRPC
ClinicalTrials.gov ID: NCT06971211
What this study is testing
What is Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone.?
Intensity-modulated radiation therapy (IMRT) in combination with fluzoparib, abiraterone acetate tablets (II), and prednisone. is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Also referred to as Treatment group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
You likely can't join if
- 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...
- Have a history of epilepsy or have experienced a disease that can trigger epileptic seizures within the 12 months prior to randomization (including a...
- Active heart disease within the first 6 months of randomization, including severe/unstable angina, myocardial infarction, symptomatic congestive...
- Individuals with active HBV and HCV infection (HBsAg positive and virus copy number ≥ 500 IU/mL, HCV antibody positive and HCV RNA above the...
See the full eligibility criteria
- 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...
- 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
- 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...
- 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...
- 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)
- 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 people who meet one or more of the following criteria: Not receiving highly effective antiretroviral therapy; Change...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.