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Tests treatment safety and results for Prostate Cancer
Official title A Clinical Study on the Efficacy and Safety of Fasudil Hydrochloride Combined With Immunotherapy in the Treatment of Metastatic Castration-resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07250542
What this study is testing
What is Fasudil hydrochloride combined with immunotherapy?
Fasudil hydrochloride combined with immunotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate cancer.
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
- Carrying out clinical trials of salbutamol hydrochloride combined with immunotherapy and castration for the treatment of prostate cancer is of great significance. Firstly, it can verify the efficacy and safety of this combination in the treatment of prostate cancer, providing a scientific basis for its clinical application.
- 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 to 85, men only
You may be able to join if
- Age ≥ 18 years and \< 85 years;
- Patients who have failed at least one chemotherapy regimen containing docetaxel and one standard novel endocrine therapy;
- Diagnosed with CRPC, defined as: after continuous castration therapy, the castration level of testosterone is \< 50 ng/ml; disease progression within...
- Imaging evidence indicates bone metastatic disease and/or measurable non-bone metastatic disease (lymph nodes or internal organs); Expected survival...
You likely can't join if
- Severe cardiovascular and cerebrovascular diseases;
- Abnormal liver function: Total bilirubin in blood is less than 1.5 times the upper limit of normal value, and the ratio of blood ALT to AST is less...
- Abnormal kidney function: Serum creatinine is less than 1.5 mg/dl or the creatinine clearance rate is greater than or equal to 60 cc/min;
- Those allergic to the used drugs;
- Those with tumors in other parts;
- Abnormal thyroid function: Blood FT4 and/or TT4 levels are higher or lower than the normal value (normal blood FT4 level is 9-25 pmol/L (0.7-1.9...
See the full eligibility criteria
- Age ≥ 18 years and \< 85 years;
- Patients who have failed at least one chemotherapy regimen containing docetaxel and one standard novel endocrine therapy;
- Diagnosed with CRPC, defined as: after continuous castration therapy, the castration level of testosterone is \< 50 ng/ml; disease progression within 12 weeks before enrollment: PSA levels increase consecutively for 3...
- Imaging evidence indicates bone metastatic disease and/or measurable non-bone metastatic disease (lymph nodes or internal organs); Expected survival period ≥ 3 months; All patients voluntarily signed the informed...
- Severe cardiovascular and cerebrovascular diseases;
- Abnormal liver function: Total bilirubin in blood is less than 1.5 times the upper limit of normal value, and the ratio of blood ALT to AST is less than 2 times the upper limit of normal value;
- Abnormal kidney function: Serum creatinine is less than 1.5 mg/dl or the creatinine clearance rate is greater than or equal to 60 cc/min;
- Those allergic to the used drugs;
- Those with tumors in other parts;
- Abnormal thyroid function: Blood FT4 and/or TT4 levels are higher or lower than the normal value (normal blood FT4 level is 9-25 pmol/L (0.7-1.9 ng/dl), normal blood TT4 level is 64-154 nmol/L (5-12 ug/dl));
- Cortisol deficiency: Serum cortisol at 8 a.m. is less than 140 nmol/L (5 ug/dL).
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, 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 to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, 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.