Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
Study NCT ID:
NCT06861192
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-03-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy of Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C049347', 'term': 'fasudil'}, {'id': 'D000726', 'term': 'Androgen Antagonists'}], 'ancestors': [{'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 83}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-03-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-03-02', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pCR or MRD rate', 'timeFrame': 'up to 4 weeks', 'description': '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;'}], 'secondaryOutcomes': [{'measure': 'PSA level change', 'timeFrame': 'At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)'}, {'measure': 'Biochemical progression-free survival after radical prostatectomy', 'timeFrame': 'The evaluation period was up to 1 year ( from the date of completion of surgery to the date of first recorded psa progression)'}, {'measure': 'Pathologic responses after radical prostatectomy (including positive surgical margin, tumor size, prostatic extension, seminal vesicle infiltration, and lymph node involvement)', 'timeFrame': 'up to 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate CA']}, 'descriptionModule': {'briefSummary': '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).\n\nThe 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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ① Age ≥18 years and ≤85 years;\n\n * Histologically confirmed prostate cancer without small cell features;\n\n * 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;\n\nExclusion Criteria:\n\n* ①Any previous or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.\n\n * Previous prostatectomy;\n\n * Any other serious basic medical, mental, psychological, and other diseases that, in the judgment of the investigator, may affect the treatment of the patient\n\n * 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;"}, 'identificationModule': {'nctId': 'NCT06861192', 'briefTitle': 'Clinical Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'A Randomized Controlled Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy for Prostate Cancer', 'orgStudyIdInfo': {'id': '2024ZDSYLL511-Y01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation treatment group', 'description': '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.', 'interventionNames': ['Drug: Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy', 'Procedure: radical prostatectomy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo combined with androgen deprivation treatment group', 'description': '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.', 'interventionNames': ['Drug: Placebo combined with androgen deprivation therapy', 'Procedure: radical prostatectomy']}], 'interventions': [{'name': 'Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation treatment group']}, {'name': 'Placebo combined with androgen deprivation therapy', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Placebo combined with androgen deprivation treatment group']}, {'name': 'radical prostatectomy', 'type': 'PROCEDURE', 'description': 'Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle', 'armGroupLabels': ['Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation treatment group', 'Placebo combined with androgen deprivation treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'resident doctor', 'role': 'CONTACT', 'email': '2978793353@qq.com', 'phone': '中国+1885069821'}], 'facility': 'Zhongda Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'resident doctor', 'role': 'CONTACT', 'email': '2978793353@qq.com', 'phone': 'China+18852069821'}], 'overallOfficials': [{'name': 'Vice President of Zhongda Hospital', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhongda Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'baotai Liang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'baotai Liang', 'investigatorAffiliation': 'Zhongda Hospital'}}}}