Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-29 @ 11:26 AM
Study NCT ID:
NCT05707468
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2022-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C089740', 'term': 'abiraterone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant hormone and RT).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2023-01-28', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year progression-free survival (PFS)', 'timeFrame': 'Assessment progression-free survival (PFS) at 3 years', 'description': 'To assess progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS).'}], 'secondaryOutcomes': [{'measure': 'quality of life (QoL)', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'quality of life (QoL)'}, {'measure': 'time to castration-resistant prostate cancer (CRPC)', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'To assess the time to castration-resistant prostate cancer (CRPC)'}, {'measure': '5-year overall survival (OS)', 'timeFrame': 'Assessment overall survival (OS) at 5 years', 'description': 'To assess the overall survival (OS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oligometastatic Prostate Carcinoma']}, 'referencesModule': {'references': [{'pmid': '40275195', 'type': 'DERIVED', 'citation': 'Fan Z, Li D, Yan S, Zhao X, Yin L, Xu W, Wang Y, Zhang H, Chang Y, Ren S. NEoAdjuvant radiohormonal therapy versus standard of care for oligometastatic prostate cancer (NEAR-TOP): study protocol of a multicenter, open-label, randomised controlled trial. BMC Cancer. 2025 Apr 24;25(1):768. doi: 10.1186/s12885-024-13201-w.'}]}, 'descriptionModule': {'briefSummary': 'The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. The aim of this trial is to compare the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) to ADT combined with abiraterone for treating OMPC.', 'detailedDescription': 'The present study will be conducted as a prospective, open-label, two arms clinical trial. Patients with ≤ 3 de novo oligometastatic PCa, diagnosed on Ga-68 prostate-specific membrane antigen (PSMA) PET/CT, will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant hormone and RT). The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone. The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued. The primary endpoints of the study are progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS). The secondary endpoints include quality of life (QoL), time to CRPC, positive surgical margin (pSM), overall survival (OS), postoperative continence, and toxicities parameters.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate without small cell features\n* Oligometastatic PCa assessed by Ga-68 prostate-specific membrane antigen (PSMA), PET/CT\n* \\<4 bone oligometastases, lymph node metastasis below the renal artery level\n* Expected survival time \\>5 years\n* World Health Organization (WHO) performance status 0-1\n* Be willing to give written informed consent.\n\nExclusion Criteria:\n\n* Any previous or ongoing treatment for PCa, including radiotherapy, ADT, chemotherapy, focal treatment, etc.\n* Patients who have previously undergone transurethral resection or enucleation of the prostate.\n* Patients who have undergone other abdominal surgery within the last 3 months\n* Patients who have visceral metastases\n* Patients with a history of long-term anticoagulant use and anti-platelet drug use and who stopped anticoagulant therapy less than 1 week before registration\n* Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis\n* Severe or active comorbidities likely to impact the advisability of radiotherapy\n* Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which, according to the judgement of the investigator, may affect the planned staging, treatment and follow-up or patient compliance or may cause high-risk treatmentrelated complications for the patient\n* Patients who have participated in other clinical trials within the last 3 months\n* Patients who refuse to undergo RALP\n* Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.'}, 'identificationModule': {'nctId': 'NCT05707468', 'briefTitle': 'Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Safety and Efficacy Study of Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer: a Multi-center Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Changhai Hospital PCa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A (hormone)', 'description': 'The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone.', 'interventionNames': ['Drug: ADT combined with abiraterone']}, {'type': 'EXPERIMENTAL', 'label': 'B (neoadjuvant hormone and RT)', 'description': 'The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.', 'interventionNames': ['Radiation: neoadjuvant hormone and RT']}], 'interventions': [{'name': 'ADT combined with abiraterone', 'type': 'DRUG', 'description': 'The patients will receive long-term ADT combined with abiraterone.', 'armGroupLabels': ['A (hormone)']}, {'name': 'neoadjuvant hormone and RT', 'type': 'RADIATION', 'description': 'The patients will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.', 'armGroupLabels': ['B (neoadjuvant hormone and RT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Di Gu, PhD', 'role': 'CONTACT'}], 'facility': 'the First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Xiang Ding, PhD', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital and Medical College of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '210009', 'city': 'Wuxi', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Ninghan Feng, PhD', 'role': 'CONTACT'}], 'facility': 'Jiangnan University Medical Center', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Zejun Yan, PhD', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Ningbo University', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'zip': '200003', 'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Shancheng Ren, PhD', 'role': 'CONTACT', 'email': 'renshancheng@gmail.com', 'phone': '021-81885721'}], 'facility': 'The Second Affiliated Hospital of Naval Medical University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Huojun Zhang, PhD', 'role': 'CONTACT', 'email': 'huojunzh@163.com', 'phone': '021-31162222'}], 'facility': 'The First Affiliated Hospital of Naval Medical University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Huojun Zhang, PhD', 'role': 'CONTACT', 'email': 'huojunzh@163.com', 'phone': '021-31162222'}, {'name': 'Xianzhi Zhao, MD', 'role': 'CONTACT', 'email': 'zhxzh0007@163.com', 'phone': '021-31162222'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Within 5 years after the publication of the study.', 'ipdSharing': 'YES', 'description': 'Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.', 'accessCriteria': 'Data may be shared with radiation oncologists and specialists in surgerywho are interested in examining the efficacy and toxicity of oligometastatic prostate cancer treated withneoadjuvant radiohormonal therapy or androgen deprivation therapy (ADT) combined with abiraterone. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Zhang Huo Jun', 'investigatorAffiliation': 'Changhai Hospital'}}}}