Prostate CancerPhase 2NCT07250542
A Clinical Study on the Efficacy and Safety of Fasudil Hydrochloride Combined With Immunotherapy in the Treatment of Metastatic Castration-resistant Prostate Cancer
A Phase 2 study testing Fasudil hydrochloride combined with immunotherapy in people with Prostate Cancer, run by baotai Liang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Fasudil hydrochloride combined with immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2024to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
baotai liang 许 contact
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing
resident doctor, 18852069821, 2978793353@qq.com
About this study
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.
Read the detailed description
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 androgen deprivation 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.
- Conditions
- Prostate Cancer
- Being tested
- Fasudil hydrochloride combined with immunotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasudil hydrochloride combined with immunotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| The group treated with farsulide hydrochloride combined with immunotherapy | Experimental | 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. Receives: Drug: Fasudil hydrochloride combined with immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA level
Before and after each cycle of treatment, blood samples were collected from the elbow vein on an empty stomach in the morning. The serum PSA level was detected using the enzyme-linked immunosorbent assay method.
Measured: About 4 months
Secondary outcomes (1)
KPS scoring scale
On the 6th day after medication administration, a quality of life assessment was conducted for the patient, referring to the KPS scoring scale. The score range is from 0 to 100, with 0 indicating death and 100 indicating normal, without any symptoms or signs. The assessment focused on the changes in the patient's quality of life, with higher scores indicating better quality of life.
Measured: About 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start5 Jul 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- baotai Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, baotai Liang, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250542
- Sponsor's protocol ID
- 2024ZDSYLL151-P01
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2024ZDSYLL151-P01
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- baotai LiangUniversity, hospital or other
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 androgen deprivation 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The group treated with farsulide hydrochloride combined with immunotherapy | Experimental | Drug: Fasudil hydrochloride combined with immunotherapyThis 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasudil hydrochloride combined with immunotherapyThis 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. | Drug | The group treated with farsulide hydrochloride combined with immunotherapy |
Primary outcome
PSA level
Time frame: About 4 months
Before and after each cycle of treatment, blood samples were collected from the elbow vein on an empty stomach in the morning. The serum PSA level was detected using the enzyme-linked immunosorbent assay method.
1 secondary outcome
KPS scoring scale
Time frame: About 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
baotai liang 许 contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fasudil hydrochloride combined with immunotherapy in people with Prostate Cancer, run by baotai Liang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact baotai liang 梁 (18852069821, 2978793353@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA level (time frame: About 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.