Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:24 AM
Study NCT ID:
NCT07311694
Status:
RECRUITING
Last Update Posted:
2026-02-04
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 370}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2025-12-30', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'radiographic progression-free survival (rPFS) assessed by the BIRC.', 'timeFrame': 'From Baseline to primary completion date, about 24 months'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'From Baseline to primary completion date, about 24 months'}, {'measure': 'rPFS（Investigator-Assessed）', 'timeFrame': 'From Baseline to primary completion date, about 24 months'}, {'measure': 'ORR （Investigator-Assessed and BIRC-Assessed）', 'timeFrame': 'From Baseline to primary completion date, about 24 months'}, {'measure': 'DCR（Investigator-Assessed and BIRC-Assessed）', 'timeFrame': 'From Baseline to primary completion date, about 24 months'}, {'measure': 'DOR（Investigator-Assessed and BIRC-Assessed）', 'timeFrame': 'From Baseline to primary completion date, about 24 months'}, {'measure': 'PSA50 Response Rate', 'timeFrame': 'From Baseline to primary completion date, about 24 months'}, {'measure': 'Time to PSA Progression', 'timeFrame': 'From Baseline to primary completion date, about 24 months'}, {'measure': 'Changes from baseline in scores of the EQ-5D-5L', 'timeFrame': 'From Baseline to primary completion date, about 24 months'}, {'measure': 'Changes from baseline in scores of the Functional FACT-P', 'timeFrame': 'From Baseline to primary completion date, about 24 months'}, {'measure': 'Changes from baseline in scores of the BPI-SF', 'timeFrame': 'From Baseline to primary completion date, about 24 months'}, {'measure': 'Assessment of the incidence and severity of adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'From Baseline to primary completion date, about 24 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced metastatic castration-resistant prostate cancer (mCRPC). The efficacy of HRS-4357 versus novel androgen receptor pathway inhibitors (ARPI) in the treatment of PSMA-positive advanced metastatic castration-resistant prostate cancer (mCRPC) will be evaluated based on radiographic progression-free survival (rPFS) assessed by the BIRC.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Be willing to participate in this clinical trial, understand the study procedures, and be able to sign the informed consent form in writing;\n2. Male, aged ≥ 18 years;\n3. ECOG performance status score of 0-1;\n4. Expected survival time of no less than 6 months;\n5. Prostate adenocarcinoma confirmed by histology and/or cytology, and diagnosed as mCRPC (metastatic castration-resistant prostate cancer) with reference to current clinical guidelines;\n6. Presence of at least one metastatic lesion confirmed by imaging examinations (CT/MRI and/or bone scan) within 4 weeks before randomization;\n7. Confirmation of at least one PSMA-positive lesion and no PSMA-negative lesions by PSMA PET/CT;\n8. Serum testosterone at castration level (\\< 50 ng/dl or \\< 1.7 nmol/L) at the screening visit; continuous luteinizing hormone-releasing hormone analog (LHRHA) therapy (medical castration) or previous bilateral orchiectomy (surgical castration); subjects who have not undergone bilateral orchiectomy must plan to maintain effective LHRHA therapy throughout the study period;\n9. Previous treatment with second-generation ARPIs, with only one episode of disease progression during treatment; and assessed by the investigator as suitable for switching to another ARPI (suitable for receiving abiraterone or enzalutamide);\n10. Disease progression at the time of enrollment. Disease progression is defined as the occurrence of at least one of the following while the subject's serum testosterone is at a stable castration level: ① PSA progression: PSA value \\> 1 ng/mL, with two consecutive increases in PSA at intervals of at least 1 week; ② Radiographic progression: occurrence of clearly new lesions; appearance of 2 or more new bone lesions on bone scan; lesion progression indicated by CT or MRI (per RECIST v1.1);\n\nExclusion Criteria:\n\n1. Received any of the following treatments before randomization:\n\n 1. Any radionuclide therapy or hemi-body radiotherapy within 6 months.\n 2. Any PSMA-targeted radiopharmaceutical therapy.\n 3. Surgery, radiotherapy, or any local therapy within 4 weeks.\n 4. Any other investigational drug intervention within 4 weeks.\n2. Known hypersensitivity to the components of the study drug or its analogs.\n3. History of malignancy (other than prostate cancer) within 5 years before randomization that is expected to alter life expectancy or may interfere with disease assessment, excluding cured malignancies with low risk of metastasis and mortality (5-year survival rate \\> 90%), such as non-metastatic basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, and low-grade superficial bladder cancer.\n4. Occurrence of severe infection (CTCAE \\> Grade 2) within 4 weeks before randomization.\n5. Failure to recover from adverse events of previous treatments (NCI-CTCAE Version 5.0 Grade \\> 1) before randomization, as judged by the investigator.\n6. Presence of poorly controlled clinical cardiac symptoms or cardiac diseases.\n7. History of physical or psychiatric illnesses/conditions that may interfere with the study objectives and assessments (including epilepsy and dementia)."}, 'identificationModule': {'nctId': 'NCT07311694', 'briefTitle': 'A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase III, Randomized, Open-Label, Multicenter Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'HRS-4357-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRS-4357 injection', 'interventionNames': ['Drug: HRS-4357 injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enzalutamide Soft Capsules / Abiraterone Acetate Tablets+ Prednisone Acetate Tablets', 'interventionNames': ['Drug: Enzalutamide；Abiraterone']}], 'interventions': [{'name': 'HRS-4357 injection', 'type': 'DRUG', 'description': 'HRS-4357 injection are administered each time, with dosing for 4 to 6 cycles', 'armGroupLabels': ['HRS-4357 injection']}, {'name': 'Enzalutamide；Abiraterone', 'type': 'DRUG', 'description': "ARPI (investigator's choice of any of the following agents, with the requirement that the agent has not been used previously):\n\n* Enzalutamide 160 mg orally once daily (qd)\n* Abiraterone 1000 mg orally once daily (qd) + Prednisone 5 mg orally twice daily (bid)", 'armGroupLabels': ['Enzalutamide Soft Capsules / Abiraterone Acetate Tablets+ Prednisone Acetate Tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201321', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dingwei Ye', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shaoli Song', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yuezheng Ti', 'role': 'CONTACT', 'email': 'yuezheng.ti@hengrui.com', 'phone': '+0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}