NCT07250542 A Clinical Study on the Efficacy and Safety of Fasudil Hydrochloride Combined With Immunotherapy in the Treatment of Metastatic Castration-resistant Prostate Cancer
| NCT ID | NCT07250542 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | baotai Liang |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-05 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-07-05 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Secondly, through clinical trials, the mechanism of action of salbutamol hydrochloride combined with immunotherapy can be further studied. Finally, this clinical trial can further expand the treatment strategies for prostate cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years and \< 85 years; 2. Patients who have failed at least one chemotherapy regimen containing docetaxel and one standard novel endocrine therapy; 3. 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 times at intervals of 1 week, and serum PSA ≥ 2 ng/ml; evaluated as soft tissue progression according to RECIST criteria, or ≥ 2 new lesions on bone scan; 4. 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 consent form and were able to cooperate with treatment and follow-up; Exclusion Criteria: 1. Severe cardiovascular and cerebrovascular diseases; 2. 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; 3. 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; 4. Those allergic to the used drugs; 5. Those with tumors in other parts; 6. 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)); 7. Cortisol deficiency: Serum cortisol at 8 a.m. is less than 140 nmol/L (5 ug/dL).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07250542 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 85 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07250542 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07250542 currently recruiting?
Yes, NCT07250542 is actively recruiting participants. Contact the research team at 2978793353@qq.com for enrollment information.
Where is the NCT07250542 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07250542 clinical trial?
NCT07250542 is sponsored by baotai Liang. The trial plans to enroll 30 participants.
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