Prostate Cancer Clinical Trials

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A Clinical Study on the Efficacy and Safety of Fasudil Hydrochloride Combined With Immunotherapy in the Treatment of Metastatic Castration-resistant Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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 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;

• 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;

Locations
Other Locations
China
Zhongda Hospital
RECRUITING
Nanjing
Contact Information
Primary
baotai liang 梁
2978793353@qq.com
18852069821
Backup
baotai liang 许
njxbseu@seu.edu.cn
Time Frame
Start Date: 2024-07-05
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 30
Treatments
Experimental: The group treated with farsulide hydrochloride combined with immunotherapy
This study is a single-arm clinical trial. Eligible patients will be included in the group receiving farsufilide hydrochloride combined with immunotherapy. After enrollment, in addition to the routine use of castration therapy, they will also receive farsufilide hydrochloride (10mg intravenous infusion) on days 1-5, and PD-1 monoclonal antibody (Tirapibep, 3mg/kg, intravenous infusion) on day 5. The treatment will be repeated every 21 days for a total of 4 times.
Related Therapeutic Areas
Sponsors
Leads: baotai Liang

This content was sourced from clinicaltrials.gov