Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT07142967
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}, {'id': 'D000726', 'term': 'Androgen Antagonists'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-08-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late toxicity (after 90 days) radiation-associated genitourinary (GU) and gastrointestinal (GI) events', 'timeFrame': 'Month 24', 'description': 'A serious toxicity event will be defined as any Grade 3 or higher genitourinary or gastrointestinal toxicity, based on NCI CTCAE v5.0.'}], 'secondaryOutcomes': [{'measure': 'Acute toxicity (occurring within 90 days of the treatment) radiation-associated genitourinary (GU) and gastrointestinal (GI) events', 'timeFrame': 'Month 24', 'description': 'A serious toxicity event will be defined as any Grade 3 or higher genitourinary or gastrointestinal toxicity, based on NCI CTCAE v5.0.'}, {'measure': 'Biochemical progression free survival', 'timeFrame': 'Month 24', 'description': 'From the time after treatment until the prostate-specific antigen (PSA) level rises, indicating a potential return of cancer.'}, {'measure': 'Distant metastasis-free survival (DMFS)', 'timeFrame': 'Month 24', 'description': 'Distant metastasis-free survival (DMFS) the time from end of treatment until the first instance of distant metastasis or death, whichever occurs first.'}, {'measure': 'Radiographic treatment response rate of target intra-prostatic lesion', 'timeFrame': 'Month 24', 'description': 'Radiographic treatment response rate is the patients whose tumors show a reduction in size or other measurable changes on imaging scans after receiving treatment.'}, {'measure': 'Expanded Prostate cancer Index Composite (EPIC-26) Short Form score', 'timeFrame': 'Month 24', 'description': 'The EPIC-26 short form scores range from 0 to 100 for each of its five domains (urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal). Higher scores indicate better health-related quality of life (HRQOL) within that domain.'}, {'measure': 'International prostate symptom score index (IPSS) score', 'timeFrame': 'Month 24', 'description': 'The IPSS index is a seven-item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six-point Likert scale, scores range from 0 to 35, with higher scores indicating more severe urinary symptoms. Scores are categorized as mild (0-7), moderate (8-19), or severe (20-35).'}, {'measure': 'International Index of Erectile Function (IIEF) score', 'timeFrame': 'Month 24', 'description': 'The IIEF 5 form is a 5-item questionnaire used to assess erectile function and diagnose erectile dysfunction (ED). Participant rate their responses using a 6-point Likert Scale (0-5). Scores range from 5 to 25. Scores are categorized as follows: 5-7 (severe ED), 8-11 (moderate ED), 12-16 (mild to moderate ED), 17-21 (mild ED), and 22-25 (no ED)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['prostate adenocarcinoma'], 'conditions': ['Intraprostatic Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the impact of prostate-specific membrane antigen/positron emission tomography (PSMA/PET)-informed magnetic resonance (MR)-guided radiation therapy on serious toxicity outcomes in patients with biopsy-proven locally radiorecurrent prostate cancer. The primary aim is to evaluate the safety of delivering MR-Linac-guided stereotactic body radiotherapy (SBRT) after prior prostate external beam radiotherapy for recurrent disease, and assess urinary toxicity outcomes at 2 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18 years of age or older male participants\n2. Biopsy proven intraprostatic prostate cancer after prior definitive external beam radiotherapy (moderate hypofractionation or Stereotactic Body Radiation Therapy (SBRT) acceptable).\n\n a. NOTE: Seminal vesicle involvement allowed\n3. Pathology confirming recurrent disease must have evidence of viable cancer as indicated with pathology interpretation where a Gleason score can be assigned\n4. Serum testosterone ≥ 50 ng/dL determined within 2 months prior to enrollment\n\n a. Prior Androgen Deprivation Therapy (ADT) use acceptable if testosterone level \\>50ng/dL\n5. At least 4 weeks must have elapsed from major surgery\n6. Karnofsky Performance Scale (KPS) ≥ 80% or Eastern Cooperative Oncology Group (ECOG) 0-1\n7. Prostate size as determined on MRI to be \\< 90 cc.\n8. International Prostatism Symptom Score (IPSS) ≤ 20\n9. Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone, and chart review-based follow-up will be acceptable for up to 5 years\n10. Presence of a T2 and/or DWI-visible prostatic lesion on mpMRI\n\n a. NOTE: Lesion visible on MRI required for enrollment but PSMA/PET avid lesion not required\n11. Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form\n\nExclusion Criteria:\n\n1. History of prostate brachytherapy (low dose rate or high dose rate)\n2. Actively undergoing androgen deprivation therapy and/or anti-androgens at time of enrollment\n3. CT or MRI or PET scan evidence of extraprostatic disease\n4. Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan\n5. History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years\n6. Patients with Crohn's disease or ulcerative colitis\n7. MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc.\n8. Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI\n9. Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction\n10. Contra-indications to receiving gadolinium contrast or PSMA radioligand\n11. Karnofsky Performance Scale (KPS) \\< 80 or ECOG 2+\n12. Grade 3 or higher toxicity experienced after the initial course of External Beam Radiation Therapy (EBRT)\n13. Disease free interval \\< 2 years\n14. Hx of Transurethral Resection Of Prostate (TURP) within the year\n15. Prior high-intensity focused ultrasound (HIFU) or Cryotherapy\n16. Prior history of urethral stricture\n17. Unable to give informed consent\n18. Unable to complete quality of life questionnaires"}, 'identificationModule': {'nctId': 'NCT07142967', 'briefTitle': 'Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)', 'orgStudyIdInfo': {'id': '24-00856'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI-Linac-based SBRT with online adaptive replanning', 'description': 'Participants will be treated with MR-guided stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate using a 1.5 Tesla (1.5T) Elekta UNITY MR-Linac system in conjunction with 4-6 months of androgen deprivation therapy (ADT).', 'interventionNames': ['Radiation: Stereotactic Body Radiation Therapy (SBRT)', 'Drug: Androgen Deprivation Therapy (ADT)']}], 'interventions': [{'name': 'Stereotactic Body Radiation Therapy (SBRT)', 'type': 'RADIATION', 'description': 'SBRT will be delivered with a prescription dose of 8 Gy x 5 fractions prescribed to the 95% isodose line encompassing the dominant recurrent intraprostatic lesion (DRIL) as seen on MRI and/or PET PSMA imaging plus 4mm (GTV+4mm=CTV\\_40). Remainder of the prostate gland minus CTV\\_40 (CTV\\_25) will be prescribed to 5 Gy x 5 fractions at the 95% isodose line.', 'armGroupLabels': ['MRI-Linac-based SBRT with online adaptive replanning']}, {'name': 'Androgen Deprivation Therapy (ADT)', 'type': 'DRUG', 'description': 'ADT would be given 0-1 months prior to planned SBRT to the prostate for total of 4-6 months. ADT will be administered via Leuprolide or Degarelix monthly injections or daily Relugolix pills.', 'armGroupLabels': ['MRI-Linac-based SBRT with online adaptive replanning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Michael Zelefsky, MD', 'role': 'CONTACT', 'email': 'Michael.zelefsky@nyulangone.org', 'phone': '646-239-9083'}], 'overallOfficials': [{'name': 'Michael Zelefsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': "The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Michael.zelefsky@nyulangone. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.", 'accessCriteria': "The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Michael.zelefsky@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}