Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-03-07 @ 3:08 AM
Study NCT ID:
NCT05076851
Status:
UNKNOWN
Last Update Posted:
2021-10-13
First Post:
2021-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599887', 'term': 'proxalutamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Proxalutamide: androgen deprivation therapy（ADT）=2:1'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-12', 'studyFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2021-10-12', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic Complete Response Rate', 'timeFrame': 'up to 6months', 'description': 'The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy'}, {'measure': 'Proportion of Subjects With Minimal Residual Disease', 'timeFrame': 'up to 6months', 'description': 'The proportion of subjects that have residual tumors with maximum diameter of 3 mm or less after radical prostatectomy'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoadjuvant Therapy \\High Risk Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study\n2. Patients must be ≥ 18，male\n3. Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma）\n4. High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml)\n5. Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection\n6. ECOG PS：0-1\n\nExclusion Criteria:\n\n1. Imaging or biopsy confirmed distant Metastatic lesion\n2. The number of regional lymph nodes metastasis \\>3\n3. Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer\n4. Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy'}, 'identificationModule': {'nctId': 'NCT05076851', 'briefTitle': 'Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'A Randomized, Controlled, Double-blind, Single Center，Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'IIT-GT0918-CN-1008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'placebo+ADT', 'interventionNames': ['Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Proxalutamide', 'description': 'Proxalutamide +ADT', 'interventionNames': ['Drug: Proxalutamide']}], 'interventions': [{'name': 'placebo', 'type': 'OTHER', 'description': 'placebo+ADT（Androgen Deprivation Therapy） ，Route of placebo administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD', 'armGroupLabels': ['placebo group']}, {'name': 'Proxalutamide', 'type': 'DRUG', 'description': 'Proxalutamide +ADT（Androgen Deprivation Therapy） ，Route of Proxalutamide administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD', 'armGroupLabels': ['Proxalutamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shun zhang, Doctor', 'role': 'CONTACT', 'email': 'explorershun@126.com', 'phone': '15050589789'}, {'name': 'Junlong Zhuang, Doctor', 'role': 'CONTACT', 'email': 'zhuangjl-2008@163.com', 'phone': '15950451917'}], 'facility': 'The Affiliated Hospital of Nanjing University Medical School', '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, Phd', 'role': 'CONTACT', 'email': 'explorershun@126.com', 'phone': '+86-15050589789'}], 'overallOfficials': [{'name': 'Hongqian Guo, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Study Chair Department of Urology, Drum Tower Hospital, Medical School of Nanjing University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hongqian Guo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Hongqian Guo', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}