Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-27 @ 12:07 PM
Study NCT ID:
NCT07208292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Study on Preoperative Application of Rezvilutamide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Prostate Specimens Removed by Surgery'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response（PCR）', 'timeFrame': 'Postoperative Immediate Pathological Diagnosis', 'description': 'A pathological complete response (pCR) signifies the complete absence of detectable invasive cancer cells in tissue surgically removed from a patient. This evaluation is made by a pathologist after a patient has undergone neoadjuvant therapy-a course of treatment before their primary surgery.'}, {'measure': 'Minimal Residual Disease(MRD)', 'timeFrame': 'Postoperative Immediate Pathological Diagnosis', 'description': 'Minimal residual disease is that not detected by conventional imaging studies and clinically the patient remains disease free. However, with time these dormant cells will awaken and disease progression occurs, resulting in clinically and radiological detectable metastatic disease.'}, {'measure': 'Biochemical Recurrence(BCR)', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'Biochemical recurrence in prostate cancer is one in which rising serum prostate-specific antigen (PSA) levels point to the existence of disease,PSA\\>0.2ng/ml'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer'], 'conditions': ['Preoperative Evaluation']}, 'descriptionModule': {'briefSummary': 'Real-world study on Preoperative Application of Rezvilutamide', 'detailedDescription': 'Observation on Postoperative and Long-term Indicators of Rezvilutamide in Perioperative Medication, Including Postoperative Pathological Complete Response Rate, Postoperative Biochemical Recurrence, etc.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A description of the population from data from Postoperative Patients with Prostate Cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological confirmation: Confirmed as prostate adenocarcinoma by ultrasound/MRI-guided prostate biopsy, with ISUP grade ≥ 2 (Gleason score ≥ 7);\n* Clinical staging (based on AJCC 8th edition):High-risk localized: cT3a or PSA \\> 20 ng/ml or Gleason score ≥ 8;Locally advanced: cT3b-4 or positive pelvic lymph nodes (cN1);\n* Surgical feasibility: Multidisciplinary team (MDT) assessment considers that R0/R1 resection can be achieved;\n* Laboratory requirements:Hemoglobin ≥ 90 g/L, platelets ≥ 100×10\\^9/L;Liver function: ALT/AST ≤ 2.5×ULN, bilirubin ≤ 1.5×ULN;Renal function: eGFR ≥ 30 mL/min/1.73m².\n\nExclusion Criteria:\n\n* Disease-related: Distant metastasis (M1, including bone metastasis or visceral metastasis);Pathology indicating neuroendocrine differentiation or small cell carcinoma component \\> 10%;\n* Treatment-related:Previous history of receiving radiotherapy, cryotherapy, or systemic chemotherapy for prostate cancer;History of other malignant tumors within 5 years (except non-melanoma skin cancer);\n* Comorbidities: Uncontrolled cardiovascular diseases (e.g., NYHA Class III heart failure, myocardial infarction within 6 months);History of severe epilepsy (requiring long-term use of anticonvulsant drugs);・Others:Known allergy to relugolix or LHRH analogs;Participation in other interventional clinical trials.'}, 'identificationModule': {'nctId': 'NCT07208292', 'acronym': 'RWS-GU001', 'briefTitle': 'Real-world Study on Preoperative Application of Rezvilutamide', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Pudong New Area Gongli Hospital'}, 'officialTitle': 'Real-world Study on Preoperative Application of Rezvilutamide', 'orgStudyIdInfo': {'id': 'GLYY1s2025-040'}, 'secondaryIdInfos': [{'id': 'mierxiati@fudan.edu.cn', 'type': 'OTHER', 'domain': 'Shanghai Pudong New Area Gongli Hospital'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mierxiati Abudurexiti, MD. PhD.', 'role': 'CONTACT', 'email': 'mierxiati@fudan.edu.cn', 'phone': '18939915308'}, {'name': 'Mierxiati Abudurexiti', 'role': 'CONTACT', 'email': 'mierxiati@fudan.edu.cn', 'phone': '+8618939915308'}], 'overallOfficials': [{'name': 'Mierxiati Abudurexiti', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Pudong New Area Gongli Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Pudong New Area Gongli Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}