Prostate CAPhase 2/3NCT06861192
Clinical Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy of Prostate Cancer
A Phase 2/3 study testing Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy and radical prostatectomy in people with Prostate CA, run by baotai Liang at 1 site in China.
Trial summary
The high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate CA
- What is being tested?
- Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy and radical prostatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2025to 16 Mar 2027
- Phase
- Phase 2/3
- 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
- ① Age ≥18 years and ≤85 years;
- Histologically confirmed prostate cancer without small cell features;
- Metastatic prostate cancer was identified by imaging examination with ≤5 oligometastases (bone or lymph node metastases) or cT3-4 stages; ④The score of ECOG (Eastern Cooperative Oncology Group) was 0-1; ⑤ All patients voluntarily sign informed consent, and can adhere to treatment and follow-up;
Who cannot join
- ①Any previous or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.
- Previous prostatectomy;
- Any other serious basic medical, mental, psychological, and other diseases that, in the judgment of the investigator, may affect the treatment of the patient
- Allergic to the drugs used; ⑤ Refuse to undergo radical prostatectomy; ⑥ According to the investigator's judgment, it is not suitable to participate in this clinical trial;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu
resident doctor, 中国+1885069821, 2978793353@qq.com
About this study
Official title: A Randomized Controlled Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy for Prostate Cancer
The high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (PSA). At the same time, few trials reported pathological complete response (pCR) and minimal residual lesion (MRD).
The purpose of this project is to verify the therapeutic effect of fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation in patients with locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through randomized controlled clinical trials, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.
Read the detailed description
This study will divide patients into two sections, and eligible patients will be enrolled. Patients with locally advanced prostate cancer or oligometastatic prostate cancer were assigned to either fasudil hydrochloride and PD1 inhibitor combined androgen deprivation therapy or placebo combined androgen deprivation therapy based on a computer-generated random sequence. In addition to routine androgen deprivation therapy, patients in the treatment group were given 10mg of fasudil hydrochloride on the 1st to 5th day and PD-1 monoclonal antibody (triprilizumab, 3mg/kg, intravenous drip) on the 5th day. In the placebo group, the same size, color and dosage form of 0.9% sodium chloride injection was used, and the administration was the same as that in the treatment group. After starting the intervention, all patients should be followed up in our hospital every treatment cycle to review blood PSA and other indicators. At the end of the treatment cycle, imaging examinations were followed up and radical prostatectomy was performed 3 weeks later (±7 days).
- Conditions
- Prostate CA
- Being tested
- Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy, Placebo combined with androgen deprivation therapy, radical prostatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapyDrug
On the 1st to 5th day, Fasudil hydrochloride (10mg of fasudil hydrochloride) was treated, and on the 5th day, PD-1 monoclonal antibody (triprilizumab, 3mg/kg, intravenous drip) was treated. The treatment was repeated every 21 days for a total of 4 times
Placebo combined with androgen deprivation therapyDrug
Days 1 to 5 were treated with placebo (0.9% sodium chloride 10mg), and days 5 were treated with placebo (0.9% sodium chloride 3mg/kg). The treatment was repeated every 21 days for a total of 4 times.
radical prostatectomyProcedure or surgery
Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation treatment group | Experimental | On the 1st to 5th day, Fasudil hydrochloride (10mg of fasudil hydrochloride) was treated, and on the 5th day, PD-1 monoclonal antibody (triprilizumab, 3mg/kg, intravenous drip) was treated. The treatment was repeated every 21 days for a total of 4 times.Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle. Receives: Drug: Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy; Procedure: radical prostatectomy |
| Placebo combined with androgen deprivation treatment group | Placebo comparator | Days 1 to 5 were treated with placebo (0.9% sodium chloride 10mg), and days 5 were treated with placebo (0.9% sodium chloride 3mg/kg). The treatment was repeated every 21 days for a total of 4 times.Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle. Receives: Drug: Placebo combined with androgen deprivation therapy; Procedure: radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR or MRD rate
pCR (pathological complete response) is defined as cancer that is not morphologically recognizable in a prostatectomy specimen; MRD (small residual lesion) was defined as the maximum cross-section size of the residual tumor ≤5 mm, and RCB (residual cancer load) ≤ 0.25cm3 (tumor volume ≤ 0.5cm3 × tumor cells ≤ 50%) was used to calculate the tumor volume through three-dimensional volume estimation according to the maximum cross-section size and number of cross-sections involved in the tumor. Correction of tumor cell structure;
Measured: up to 4 weeks
Secondary outcomes (3)
PSA level change
Measured: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Biochemical progression-free survival after radical prostatectomy
Measured: The evaluation period was up to 1 year ( from the date of completion of surgery to the date of first recorded psa progression)
Pathologic responses after radical prostatectomy (including positive surgical margin, tumor size, prostatic extension, seminal vesicle infiltration, and lymph node involvement)
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start16 Feb 2025
- Primary completion16 Mar 2026 (estimated)
- Study completion16 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CAStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- baotai Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, baotai Liang, Zhongda Hospital
- Investigators
- Vice President of Zhongda Hospital, Study director, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861192
- Sponsor's protocol ID
- 2024ZDSYLL511-Y01
- Status last verified
- Nov 2025
- First submitted
- 2 Mar 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT06861192
- Acronym / sponsor ID
- 2024ZDSYLL511-Y01
- Conditions
- Prostate CA
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- baotai LiangUniversity, hospital or other
- Study start
- 16 Feb 2025 (actual)
- Primary completion
- 16 Mar 2026 (estimated)
- Study completion
- 16 Mar 2027 (estimated)
- First posted
- 6 Mar 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.
The high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (PSA). At the same time, few trials reported pathological complete response (pCR) and minimal residual lesion (MRD).
The purpose of this project is to verify the therapeutic effect of fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation in patients with locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through randomized controlled clinical trials, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.
Detailed description
This study will divide patients into two sections, and eligible patients will be enrolled. Patients with locally advanced prostate cancer or oligometastatic prostate cancer were assigned to either fasudil hydrochloride and PD1 inhibitor combined androgen deprivation therapy or placebo combined androgen deprivation therapy based on a computer-generated random sequence. In addition to routine androgen deprivation therapy, patients in the treatment group were given 10mg of fasudil hydrochloride on the 1st to 5th day and PD-1 monoclonal antibody (triprilizumab, 3mg/kg, intravenous drip) on the 5th day. In the placebo group, the same size, color and dosage form of 0.9% sodium chloride injection was used, and the administration was the same as that in the treatment group. After starting the intervention, all patients should be followed up in our hospital every treatment cycle to review blood PSA and other indicators. At the end of the treatment cycle, imaging examinations were followed up and radical prostatectomy was performed 3 weeks later (±7 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation treatment group | Experimental | Drug: Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy, Procedure: radical prostatectomyOn the 1st to 5th day, Fasudil hydrochloride (10mg of fasudil hydrochloride) was treated, and on the 5th day, PD-1 monoclonal antibody (triprilizumab, 3mg/kg, intravenous drip) was treated. The treatment was repeated every 21 days for a total of 4 times.Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle. |
| Placebo combined with androgen deprivation treatment group | Placebo comparator | Drug: Placebo combined with androgen deprivation therapy, Procedure: radical prostatectomyDays 1 to 5 were treated with placebo (0.9% sodium chloride 10mg), and days 5 were treated with placebo (0.9% sodium chloride 3mg/kg). The treatment was repeated every 21 days for a total of 4 times.Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ① Age ≥18 years and ≤85 years;
Key exclusion criteria (4 listed)
- ①Any previous or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.
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 and PD1 inhibitor combined with androgen deprivation therapyOn the 1st to 5th day, Fasudil hydrochloride (10mg of fasudil hydrochloride) was treated, and on the 5th day, PD-1 monoclonal antibody (triprilizumab, 3mg/kg, intravenous drip) was treated. The treatment was repeated every 21 days for a total of 4 times | Drug | Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation treatment group |
| Placebo combined with androgen deprivation therapyDays 1 to 5 were treated with placebo (0.9% sodium chloride 10mg), and days 5 were treated with placebo (0.9% sodium chloride 3mg/kg). The treatment was repeated every 21 days for a total of 4 times. | Drug | Placebo combined with androgen deprivation treatment group |
| radical prostatectomyRadical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle | Procedure or surgery | Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation treatment group, Placebo combined with androgen deprivation treatment group |
Primary outcome
pCR or MRD rate
Time frame: up to 4 weeks
pCR (pathological complete response) is defined as cancer that is not morphologically recognizable in a prostatectomy specimen; MRD (small residual lesion) was defined as the maximum cross-section size of the residual tumor ≤5 mm, and RCB (residual cancer load) ≤ 0.25cm3 (tumor volume ≤ 0.5cm3 × tumor cells ≤ 50%) was used to calculate the tumor volume through three-dimensional volume estimation according to the maximum cross-section size and number of cross-sections involved in the tumor. Correction of tumor cell structure;
3 secondary outcomes
PSA level change
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Biochemical progression-free survival after radical prostatectomy
Time frame: The evaluation period was up to 1 year ( from the date of completion of surgery to the date of first recorded psa progression)
Pathologic responses after radical prostatectomy (including positive surgical margin, tumor size, prostatic extension, seminal vesicle infiltration, and lymph node involvement)
Time frame: up to 4 weeks
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 18 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Vice President of Zhongda Hospital study director
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy and radical prostatectomy in people with Prostate CA, 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 3 inclusion and 4 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 18 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 resident doctor (China+18852069821, 2978793353@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR or MRD rate (time frame: up to 4 weeks). 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 18 Nov 2025.