Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-28 @ 7:06 AM
Study NCT ID:
NCT05753566
Status:
RECRUITING
Last Update Posted:
2023-03-06
First Post:
2023-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year biochemical progression-free survival', 'timeFrame': '24 months', 'description': 'For arm 1, biochemical progression is defined as a confirmed prostate specific antigen (PSA) greater than (\\>) 0.2 nanogram per milliliter (ng/ml)'}, {'measure': '3-year biochemical progression-free survival', 'timeFrame': '36 months', 'description': 'For arm 2, biochemical progression is defined as a confirmed PSA greater than (\\>) 0.2 ng/ml( the time interval should be over 2 weeks)'}], 'secondaryOutcomes': [{'measure': 'biochemical progression-free survival', 'timeFrame': '36 months', 'description': 'Time from entry to biochemical progression or death due to any cause.'}, {'measure': 'progression-free survival (PFS)', 'timeFrame': '36 months', 'description': 'Time from entry to biochemical progression or radiologically confirmed progressive disease or death due to any cause.'}, {'measure': 'metastasis-free survival (MFS)', 'timeFrame': '36 months', 'description': 'Time from entry to radiologically confirmed metastasis disease or death due to any cause.'}, {'measure': 'Quality of life as determined by FACT-P scores', 'timeFrame': 'At baseline, 3 months, 6 months, every 3 months up to 3 years', 'description': 'Quality of life as determined by Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores'}, {'measure': 'Quality of life as determined by EPIC-26 questionnaire', 'timeFrame': 'At baseline, 3 months, 6 months, every 3 months up to 3 years', 'description': 'Quality of life as determined by Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire'}, {'measure': 'Number of Adverse Events', 'timeFrame': '36 months', 'description': 'Number of Adverse Events'}, {'measure': 'Duration of testosterone recovery', 'timeFrame': '36 months', 'description': 'Duration of testosterone recovery'}, {'measure': 'Time to testosterone recovery to >50 ng/dl', 'timeFrame': '36 months', 'description': 'Time to testosterone recovery to \\>50 ng/dl'}, {'measure': 'Time to testosterone recovery to >300 ng/dl', 'timeFrame': '36 months', 'description': 'Time to testosterone recovery to \\>300 ng/dl'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'Biochemical recurrence', 'Rezvilutamide'], 'conditions': ['Prostate Cancer', 'Biochemical Recurrence']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or rezvilutamide in combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n1. Age ≥ 40 years, male.\n2. Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.\n3. pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);\n4. Patients with PSA \\< 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;\n5. Biochemical recurrence (two consecutive rises in PSA with absolute values \\> 0.2ng/ml, the time interval ≥ 2 weeks apart ) and no local recurrence or distant metastatic lesions on conventional imaging (bone scan and CT/MRI scan);\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;\n7. Estimated life expectancy \\>10 year;\n8. Adequate laboratory parameters\n\n * Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\\^9/L\n * Platelet count (PLT) ≥ 100 x 10\\^9/L\n * Haemoglobin (Hb) ≥ 90 g/L\n * Serum creatinine (Cr) ≤ 1.5 x upper limit of normal(ULN) or creatinine clearance \\> 50 ml/min.\n * Total bilirubin (TBIL) ≤ 1.5 x ULN.\n * Glutamic oxaloacetic transaminase (AST/SGOT) or glutamic alanine transaminase (ALT/SGPT) levels ≤ 2.5 x ULN.\n * International normalised ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5 x ULN .\n * Left ventricular ejection fraction (LVEF) ≥ 50%.\n9. Patients able to comply with the protocol. Arm 1 subjects are proposed to receive salvage radiation therapy, while arm 2 subjects are not suitable for or refuse radiation therapy.\n10. Signed informed consent.\n\nMain Exclusion Criteria:\n\n1. Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .\n2. Postoperative biochemical recurrence with PSA \\> 2 ng/ml.\n3. Postoperative pathology containing neuro-endocrine differentiation or small cell features.\n4. Prior malignancy other than prostate cancer in the past three years.\n5. History of any of the following:\n\n * Seizure or known condition that may pre-dispose to seizure\n * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to entry.\n * Active infection (eg, human immunodeficiency virus \\[HIV\\] or viral hepatitis)\n6. Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.'}, 'identificationModule': {'nctId': 'NCT05753566', 'briefTitle': 'Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Efficacy and Safety of Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: A Prospective, Multi-centre Study', 'orgStudyIdInfo': {'id': 'IUNU-PC-119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rezvilutamide +ADT+ SRT', 'description': 'Rezvilutamide along with ADT for 6 cycles (28 days for each cycle) in combination with salvage radiation therapy (SRT) according to standard of care', 'interventionNames': ['Drug: Rezvilutamide', 'Drug: Androgen deprivation therapy (ADT)', 'Radiation: SRT']}, {'type': 'EXPERIMENTAL', 'label': 'Rezvilutamide +ADT', 'description': 'Rezvilutamide along with ADT for 12 cycles (28 days for each cycle)', 'interventionNames': ['Drug: Rezvilutamide', 'Drug: Androgen deprivation therapy (ADT)']}], 'interventions': [{'name': 'Rezvilutamide', 'type': 'DRUG', 'otherNames': ['SHR3680'], 'description': 'Specifications of 80 mg; orally, once a day', 'armGroupLabels': ['Rezvilutamide +ADT', 'Rezvilutamide +ADT+ SRT']}, {'name': 'Androgen deprivation therapy (ADT)', 'type': 'DRUG', 'description': 'Androgen deprivation therapy (ADT), the ADT used by each subject will be determined by the investigator, and the dose and frequency of administration will be consistent with the prescription information', 'armGroupLabels': ['Rezvilutamide +ADT', 'Rezvilutamide +ADT+ SRT']}, {'name': 'SRT', 'type': 'RADIATION', 'description': 'SRT according to standard of care (66.6-72 grays will be delivered to the bed of prostate ,\\~50.4 grays to the pelvis if needed)', 'armGroupLabels': ['Rezvilutamide +ADT+ SRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongqian Guo, Phd', 'role': 'CONTACT', 'email': 'dr.ghq@nju.edu.cn', 'phone': '8613605171690'}, {'name': 'Shun Zhang, MD', 'role': 'CONTACT', 'email': 'explorershun@126.com', 'phone': '8615050589789'}], 'facility': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qing Zou', 'role': 'CONTACT'}], 'facility': 'JiangSu Cancer Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Hongqian Guo, phD', 'role': 'CONTACT', 'email': 'dr.ghq@nju.edu.cn', 'phone': '+86-13605171690'}, {'name': 'Shun Zhang, MD', 'role': 'CONTACT', 'email': 'explorershun@126.com', 'phone': '+86-15050589789'}], 'overallOfficials': [{'name': 'Chief physician of Department of Urology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician of Department of Urology', 'investigatorFullName': 'Hongqian Guo', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}