Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 7:56 AM
Study NCT ID:
NCT03652493
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2018-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2018-07-25', 'studyFirstSubmitQcDate': '2018-08-28', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of carboplatin on metastatic prostatic carcinoma resistant to castration Efficacy of carboplatin: The best radiological tumoral response rate', 'timeFrame': 'Up to 27 weeks (9 cycles)', 'description': 'Tumoral response rate (TR) defined according to the recommendations of the PCWG3 criteria : Objective radiological response'}, {'measure': 'Efficacy of carboplatin: biological response rate defined by value of PSA', 'timeFrame': 'Up to 27 weeks (9 cycles)', 'description': 'Biological response rate (TR) defined according to the recommendations of the PCWG3 criteria : Decrease of PSA ≥ 50%,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anomaly of the Homologous Recombination (HR) pathway', 'Carboplatin'], 'conditions': ['Castration-resistant Prostate Cancer', 'Metastasis']}, 'referencesModule': {'references': [{'pmid': '38425504', 'type': 'DERIVED', 'citation': 'Coquan E, Penel N, Lequesne J, Leman R, Lavaud P, Neviere Z, Brachet PE, Meriaux E, Carnot A, Boutrois J, Castera M, Goardon N, Muller E, Leconte A, Thiery-Vuillemin A, Clarisse B, Joly F. Carboplatin in metastatic castration-resistant prostate cancer patients with molecular alterations of the DNA damage repair pathway: the PRO-CARBO phase II trial. Ther Adv Urol. 2024 Feb 28;16:17562872241229876. doi: 10.1177/17562872241229876. eCollection 2024 Jan-Dec.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose a phase II study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the Homologous Recombination (HR) pathway.\n\nThis study may also better characterize the molecular abnormalities of tumors required for the carboplatin response'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years old\n* Patients with adenocarcinoma or poorly differentiated prostate carcinoma, histologically confirmed (small-cell histology or high-grade neuroendocrine histology excluded)\n* Tumor presenting a somatic pathogenic variant likely to alter the homologous recombination pathway previously detected on a tumor biopsy or on circulating tumor DNA, or germinal mutation among the list of genes defined in the study\n* Castration-resistant tumor defined by progression despite well-conducted androgen deprivation treatment: testosterone ≤50ng /dL agonist / antagonist of luteinizing hormone-releasing hormone (LHRH) or surgical castration. The patient must agree to continue concomitant LHRH-mediated (agonist or antagonist) therapy throughout the duration of the study regimen for patients with no history of surgical castration.\n* Patients must have performed at least one line of chemotherapy by taxane in case of castration resistance:\n\n * Patients who have received docetaxel treatment in a hormone-sensitive situation must have received at least treatment with cabazitaxel in case of castration resistance\n * Patients who have not received chemotherapy in a hormone-sensitive situation must have received docetaxel AND cabazitaxel or have a contraindication to discontinue treatment.\n* Patients must have been treated with at least 2nd generation hormone therapy (eg, abiraterone acetate or enzalutamide)\n* Patients may have been treated with a poly (ADP-ribose) polymerase inhibitor (PARP)\n* Performance Status \\<2\n* Metastatic disease progressive\n\nExclusion Criteria:\n\n* Absence of previous treatment with taxane in situation of sensitivity or resistance to castration.\n* Absence of previous treatment with cabazitaxel in case of resistance to castration (except contraindication explaining the non-administration of treatment)\n* No treatment with 2nd generation hormone therapy (eg abiraterone acetate or enzalutamide) unless contraindicated to explain non-administration of treatment\n* Previous treatment with platinum\n* Symptomatic and untreated central nervous system (CNS) metastases. Patients with asymptomatic and pre-treated CNS metastases are included if they are clinically stable (not requiring corticosteroid therapy for 28 days) and must have a brain MRI evaluation at screening and during follow-up.'}, 'identificationModule': {'nctId': 'NCT03652493', 'acronym': 'PRO-CARBO', 'briefTitle': 'Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Multicentre, Open-label Phase 2 Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway', 'orgStudyIdInfo': {'id': '2017-004764-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CARBOPLATIN', 'description': 'CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles', 'interventionNames': ['Drug: Carboplatin']}], 'interventions': [{'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Tumoral evaluation every 3 cycles', 'armGroupLabels': ['CARBOPLATIN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Chu Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave ROUSSy IGR', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'collaborators': [{'name': 'French Interregional Group of Clinical Research and Innovation', 'class': 'OTHER'}, {'name': 'Ligue Contre le Cancer (French association Against Cancer)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}