Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-31 @ 1:00 AM
Study NCT ID:
NCT05557604
Status:
RECRUITING
Last Update Posted:
2022-09-28
First Post:
2022-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D017329', 'term': 'Triptorelin Pamoate'}, {'id': 'D016729', 'term': 'Leuprolide'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Subjects who meet all study eligibility criteria will be randomly assigned in a 1:1 ratio.\n\nRandomization is centralized at the promoter and takes place according to a specific procedure (in attachment).\n\nThe randomization schedule will be generated by an independent group of the promoter.\n\nPatient study number and result of randomization will be given immediately by email.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, open, randomized phase 2 trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-23', 'studyFirstSubmitDate': '2022-09-23', 'studyFirstSubmitQcDate': '2022-09-23', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-yr bNED survival', 'timeFrame': '3 years', 'description': 'The primary objective of the study is 3-yr bNED survival. If bNED survival is not significantly different between the two experimental arms, the one without AD will be chosen in a future comparison with the standard of care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neoplasm, prostate cancer,'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open, randomized phase II trial.', 'detailedDescription': 'Patients will be randomized between SBRT alone (38 Gy in 4 fractions) or SBRT (same schedule) along with short course (6 months) androgen deprivation (STAD). All patients will be treated by intensity modulated radiotherapy. Regarding the combined modality approach, SBRT has to start within 3 months from the first injection of LHRH analogue.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven prostate adenocarcinoma\n* IR or HR in the NCCN definition\n* N0M0 at staging with choline or (preferably) PSMA PET-CT;\n* ECOG performance status between 0 and 2;\n\nExclusion Criteria:\n\n* Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy)\n* Previous radiotherapy to the pelvis\n* Previous chemotherapy for malignancy in past 5 years\n* Impossibility to implant fiducials for tracking purposes\n* Impossibility to undergo MRI of the prostate\n* Contraindication to short term AD\n* Prostate volume \\>90cc'}, 'identificationModule': {'nctId': 'NCT05557604', 'acronym': 'STUNNIN', 'briefTitle': 'Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study', 'orgStudyIdInfo': {'id': 'RS1399/20(2384) PU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'arm 1', 'description': 'SBRT alone 38 GY in 4 fractions'}, {'type': 'EXPERIMENTAL', 'label': 'arm 2', 'description': 'SBRT along with short course (6 months) androgen deprivation (STAD)', 'interventionNames': ['Drug: Decapeptyl']}], 'interventions': [{'name': 'Decapeptyl', 'type': 'DRUG', 'otherNames': ['Enantone'], 'description': 'STAD androgen deprivation', 'armGroupLabels': ['arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Rome', 'state': 'Lazio', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Sanguineti, Professor', 'role': 'CONTACT', 'email': 'giuseppe.sanguineti@ifo.it', 'phone': '0652661530'}, {'name': 'Paola Franzoso, DM', 'role': 'CONTACT', 'email': 'paola.franzoso@ifo.it', 'phone': '0652666125'}], 'facility': 'Ifo Regina elena', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00144', 'city': 'Rome', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'giuseppe sanguineti, Professor', 'role': 'CONTACT', 'email': 'giuseppe.sanguineti@ifo.it', 'phone': '0652661530'}, {'name': 'Paola Franzoso, data manager', 'role': 'CONTACT', 'email': 'paola.franzoso@ifo.it', 'phone': '0652666125'}], 'facility': 'ifo Regina Elena', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00144', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'giuseppe sanguineti, Professor', 'role': 'CONTACT', 'email': 'giuseppe.sanguineti@ifo.it', 'phone': '0652661530'}, {'name': 'Paola Franzoso, DM', 'role': 'CONTACT', 'email': 'paola.franzoso@ifo.it', 'phone': '0652666125'}], 'facility': 'Regina Elena National Cancer Institute', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Giuseppe Sanguineti, Professor', 'role': 'CONTACT', 'email': 'giuseppe.sanguineti@ifo.it', 'phone': '0652663015'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professore', 'investigatorFullName': 'Giuseppe Sanguineti', 'investigatorAffiliation': 'Regina Elena Cancer Institute'}}}}