Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 5:17 PM
Study NCT ID:
NCT06391034
Status:
RECRUITING
Last Update Posted:
2024-11-20
First Post:
2024-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 161}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2032-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signal-to-noise ratio (Part 1)', 'timeFrame': 'Day of MR imaging (1 day)', 'description': 'A signal-to-noise ratio is defined as a MR/spectroscopy parameter, consisting of the HP C13-Pyruvate or Lactate signal (peak) relative to background noise level (baseline) in MRI spectra of the tissue.'}, {'measure': 'Mean HP 13C-pyruvate to lactate metabolic rate of conversion (kPL) over time (Part 2A)', 'timeFrame': 'Up to 24 months', 'description': 'The mean percent change in tumoral kPL between baseline and 1-year post-SBRT will be reported.'}, {'measure': 'Mean HP 13C-pyruvate to glutamate metabolic rate of conversion (kPG) over time (Part 2A)', 'timeFrame': 'Up to 24 months', 'description': 'The mean percent change in tumoral kPG between baseline and 1-year post-SBRT will be reported.'}, {'measure': 'Mean change in on-treatment kPL over time (Part 2B)', 'timeFrame': 'Up to 24 months', 'description': 'Mean percent change in tumoral kPL for participants receiving systemic hormone therapy between baseline and 1 -year post-SBRT will be reported.'}, {'measure': 'Mean change in on-treatment kPG over time (Part 2B)', 'timeFrame': 'Up to 24 months', 'description': 'Mean percent change in tumoral kPG for participants receiving systemic hormone therapy between baseline and 1 -year post-SBRT will be reported.'}, {'measure': 'Mean kPL at time of biochemical failure (Part 3)', 'timeFrame': 'Up to 24 months', 'description': 'The mean kPL for participants with biochemical failure will be reported.'}, {'measure': 'Mean kPG at time of biochemical failure (Part 3)', 'timeFrame': 'Up to 24 months', 'description': 'The mean kPG for participants with biochemical failure will be reported.'}], 'secondaryOutcomes': [{'measure': 'Intra-patient variability of kPL', 'timeFrame': 'Up to 12 months', 'description': 'Intra-patient variability in the kPL will be summarized by the intraclass correlation and presented with a 90% confidence interval when multiple HP-MRI scans are obtained for a participant.'}, {'measure': 'Intra-patient variability of kPG', 'timeFrame': 'Up to 12 months', 'description': 'Intra-patient variability in the kPG will be summarized by the intraclass correlation and presented with a 90% confidence interval when multiple HP-MRI scans are obtained for a participant.'}, {'measure': 'Mean intra-tumoral kPL above and below the median PSA (Parts 2-3) and the mean serum PSA', 'timeFrame': 'Up to 24 months', 'description': 'The study cohort will be dichotomized by mean intra-tumoral kPL obtained at baseline with median serum PSA and will be compared between the two dichotomized subgroups using Mann-Whitney test.'}, {'measure': 'Correlation of kPL with Prostate Imaging Reporting and Data System (PI-RADS) version 2 classification score', 'timeFrame': 'Up to 24 months', 'description': "Spearman's rank order correlation coefficient will be used to determine the relationship between kPL with PI-RADS version 2 classification score (1 through 5; PI-RADS 1 - Very low (clinically significant cancer is highly unlikely to be present) PI-RADS 2 - Low (clinically significant cancer is unlikely to be present)). The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association."}, {'measure': 'Correlation of kPG with PI-RADS version 2 classification score', 'timeFrame': 'Up to 24 months', 'description': "Spearman's rank order correlation coefficient will be used to determine the relationship between kPL with PI-RADS version 2 classification score (1 through 5; PI-RADS 1 - Very low (clinically significant cancer is highly unlikely to be present) PI-RADS 2 - Low (clinically significant cancer is unlikely to be present)). The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association."}, {'measure': 'Proportion of participants with concordant mismatch of low HP 13C-urea perfusion (ureaAUC)', 'timeFrame': 'Up to 24 months', 'description': 'A secondary endpoint will be to identify concordant mismatch of low HP 13C-urea perfusion (ureaAUC) in lesions assessed for kPL.'}, {'measure': 'Mean percent change in kPL over time for participants with optional scan', 'timeFrame': 'Up to 24 months', 'description': 'For the subset of participants who undergo optional follow up MR scan following baseline MRI, the mean percent change from baseline in kPL will be descriptively reported using summary statistics.'}, {'measure': 'Number of participants with reported treatment-related adverse events', 'timeFrame': 'From start of HP 13C-pyruvate MR imaging to 20 minutes after the procedure for all scans', 'description': 'The incidence of adverse events as graded by Common Toxicity Criteria version 5.0 will be determined'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Imaging Studies', 'Hyperpolarized 13C-Pyruvate'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2 clinical study of hyperpolarized (HP) 13C-pyruvate (13C), 15N-urea (13C,15N) metabolic MR imaging in prostate cancer patients who are undergoing or have received radiation therapy for prostate cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Part 1: To Optimize the imaging sequences that maximize signal-to-noise ratio (SNR) and intra-tumoral kPL and kPG in regions of tumor vs. adjacent benign tissue as assessed by mpMRI imaging characteristics.\n\nII. Part 2A To perform HP 13C-MRI and measure the changes in tumoral kPL and kPG.\n\nIII. Part 2B: To perform HP 13C-MRI and study the metabolic effects (changes in tumor kPL and kPG).\n\nIV. Part 3: To perform HP 13C-MRI at time of Biochemical Failure and measure tumoral kPL and kPG, in previously SBRT treated patients.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated dose studies (Part 1, 2 \\& 3).\n\nII. To determine the association between peak intra-tumoral kPL observed on baseline imaging with serum PSA. (Part 2 \\& 3).\n\nIII. To determine the association between changes in intra-tumor kPL after 4-12 weeks of systemic hormone therapy and PSA response (Part 2B).\n\nIV. To compare and contrast intra-tumoral kPL and kPG with Prostate Imaging Reporting and Data System (PI-RADS) version 2 and individual mpMRI parameters including apparent diffusion coefficient (ADC) on diffusion-weighted imaging (Part 1, 2 \\& 3).\n\nV. To describe the frequency of up-grading of tumor with MR/US-guided fusion biopsy obtained following baseline HP-MRI exam. (Part 3).\n\nVI. To further characterize the safety profile of HP C-13 pyruvate injections (Part 1, 2 \\& 3).\n\nVII. For patients imaged with HP 13C-MRI at time of biochemical failure post-SBRT, correlate peak intra-tumoral kPL and kPG with radiotherapy dose distributions from SBRT course (Part 3).\n\nVIII. For studies incorporating HP 13C-urea, the baseline and the on-treatment changes in ureaAUC parameter will be measured and compared to kPL endpoints of the same lesions (Part 1, 2 \\& 3).\n\nOUTLINE:\n\nThe study is divided into 3 parts. Part 1: Participants undergo imaging as part of a multi-parametric magnetic resonance imaging (mpMRI) exam to determine exact parameters for imaging.\n\nPart 2A: Participants planned for stereotactic body radiotherapy (SBRT) Part 2B: Participants with high-risk localized prostate cancer planned to receive primary radiation therapy with concurrent systemic hormone therapy Part 3: Evaluable SBRT participants scanned at time of biochemical failure and MR/US fusion-guided prostate biopsy within 12 weeks. Participants have the option of undergoing a follow up HP Pyruvate +/- Urea MR exam 6-15 months following the baseline scan.\n\nAll participants will receive a scan at baseline and other procedures may be performed as part of routine, non-interventional standard of care at the time of biochemical failure, including serial prostate-specific antigen (PSA) monitoring and gene expression profiling of tumor tissue. Participants will be followed for 24 months after last procedure or removal from study, or until death, whichever occurs first.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants must have biopsy-proven adenocarcinoma of the prostate, as determined by medical chart review.\n2. For:\n\n 1. Part 1: Participants post-radiation therapy or currently considering SBRT.\n 2. Part 2A: Participants currently scheduled for or considering SBRT (no neo-adjuvant therapy planned).\n 3. Part 2B: Participants currently scheduled for or considering SBRT and neo-adjuvant therapy is planned. The participant has biopsy-proven adenocarcinoma of the prostate with high-risk disease, defined by the presence of at least two of following criteria: a tumor stage of T3 or T4, a Gleason score of 8 to 10, or a PSA level ≥40 ng/mL) and the participant must be planning to receive androgen deprivation therapy (ADT) with an Luteinizing hormone-releasing hormone (LHRH) agonist or antagonist. The addition of an androgen-receptor (AR) signaling inhibitor (e.g., abiraterone, bicalutamide,apalutamide, enzalutamide or darolutamide) will be allowed.\n 4. Part 3: Participants who have previously received radiation treatment to the prostate and are exhibiting signs of biochemical failure, with planned fusion biopsy within 12 weeks following completion of baseline HP 13C pyruvate +/-urea mpMRI.\n3. Participant is able and willing to comply with study procedures and provide signed and dated informed consent.\n4. Eastern Cooperative Oncology Group (ECOG) performance status \\<= 1.\n5. Age \\>= 18 years old at time of study entry.\n6. Ability to understand and the willingness to sign a written informed consent document.\n7. Demonstrates adequate organ function as defined below:\n\n 1. White Blood Cell count (WBC) \\>=4000 cells/μL.\n 2. Hemoglobin ≥9.0 gm/dL.\n 3. Platelets ≥75,000 cells/μL.\n 4. Renal Function \\> 30 Epithelial Growth Factor Receptor (eGFR).\n\nExclusion Criteria:\n\n1. Evidence of pelvic regional or distant metastatic disease on conventional imaging (MRI, computed tomography or whole body bone scan) or prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET) imaging. PSMA-avid lymph nodes confined to the pelvis will be allowed if \\<1 centimeter (cm).\n2. Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI.\n3. Poorly controlled hypertension, with blood pressure at study entry \\> 160 mm Hg systolic or \\> 100 mm Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted.\n4. Contraindication to or inability to tolerate MRI with endorectal coil (e.g. severe claustrophobia, presence of cardiac pacemaker, aneurysm clip, severe or painful hemorrhoids, rectal stricture).\n5. Congestive heart failure with New York Heart Association (NYHA) status \\>= 2.\n6. History of clinically significant ECG abnormality, including QT prolongation, a family history of prolonged QT interval syndrome or myocardial infarction within 6 months of study entry.'}, 'identificationModule': {'nctId': 'NCT06391034', 'briefTitle': 'Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer Undergoing Radiation Therapy', 'orgStudyIdInfo': {'id': '24922'}, 'secondaryIdInfos': [{'id': '5R01CA238379', 'link': 'https://reporter.nih.gov/quickSearch/5R01CA238379', 'type': 'NIH'}, {'id': 'NCI-2024-03775', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Image Optimization Group', 'description': 'Participants will undergo Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea imaging as part of a multi-parametric magnetic resonance imaging (mpMRI) exam, with the primary objective of optimizing imaging sequences and techniques to maximize signal-to-noise ratio of imaging modality.', 'interventionNames': ['Drug: hyperpolarized pyruvate +/-urea (13C/15N)', 'Procedure: Multi-parametric magnetic resonance imaging (mpMRI)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2A: Prospective imaging (Stereotactic body radiotherapy (SBRT) Participants)', 'description': 'Participants with pre-planned, non-interventional stereotactic body radiotherapy (SBRT) will undergo an HP Pyruvate +/-Urea mpMRI exam at baseline, at 3 months post-SBRT treatment and at 1yr post-treatment.', 'interventionNames': ['Drug: hyperpolarized pyruvate +/-urea (13C/15N)', 'Radiation: Non-investigational Stereotactic body radiotherapy (SBRT)', 'Procedure: Multi-parametric magnetic resonance imaging (mpMRI)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2B: Prospective imaging (High-risk localized prostate cancer)', 'description': 'Participants with with high-risk localized prostate cancer and have pre-planned, non-interventional primary radiation therapy (RT) with concurrent, systemic, non-interventional hormone therapy will undergo HP Pyruvate+/-Urea mpMRI at baseline prior to the start of systemic hormone therapy, 4-12 weeks after the initiation of systemic hormone therapy (prior to radiation therapy), at 3 months post-radiation therapy, and at +1yr post-radiation therapy.', 'interventionNames': ['Drug: hyperpolarized pyruvate +/-urea (13C/15N)', 'Procedure: Radiotherapy (RT)', 'Procedure: Multi-parametric magnetic resonance imaging (mpMRI)', 'Biological: Non-interventional hormone therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: SBRT participants at time of biochemical recurrence (BCR)', 'description': 'Evaluable SBRT participants who undergo HP Pyruvate +/-Urea mpMRI at time of biochemical failure, followed by magnetic resonance (MR) / ultrasound (US) fusion-guided prostate biopsy within 12 weeks following baseline MR exam. Participants in this group have the option of undergoing a follow up HP Pyruvate +/-Urea MR exam 6-15 months following the baseline scan, to evaluate for any interval change.', 'interventionNames': ['Drug: hyperpolarized pyruvate +/-urea (13C/15N)', 'Radiation: Non-investigational Stereotactic body radiotherapy (SBRT)', 'Procedure: Multi-parametric magnetic resonance imaging (mpMRI)', 'Procedure: Prostate Biopsy']}], 'interventions': [{'name': 'hyperpolarized pyruvate +/-urea (13C/15N)', 'type': 'DRUG', 'otherNames': ['13C-Pyruvate,15N-urea'], 'description': 'Given IV', 'armGroupLabels': ['Part 1: Image Optimization Group', 'Part 2A: Prospective imaging (Stereotactic body radiotherapy (SBRT) Participants)', 'Part 2B: Prospective imaging (High-risk localized prostate cancer)', 'Part 3: SBRT participants at time of biochemical recurrence (BCR)']}, {'name': 'Non-investigational Stereotactic body radiotherapy (SBRT)', 'type': 'RADIATION', 'otherNames': ['SBRT'], 'description': 'Stereotactic body radiotherapy given outside of this study', 'armGroupLabels': ['Part 2A: Prospective imaging (Stereotactic body radiotherapy (SBRT) Participants)', 'Part 3: SBRT participants at time of biochemical recurrence (BCR)']}, {'name': 'Radiotherapy (RT)', 'type': 'PROCEDURE', 'otherNames': ['RT'], 'description': 'Radiation therapy given outside of this study', 'armGroupLabels': ['Part 2B: Prospective imaging (High-risk localized prostate cancer)']}, {'name': 'Multi-parametric magnetic resonance imaging (mpMRI)', 'type': 'PROCEDURE', 'otherNames': ['mpMRI'], 'description': 'Imaging scan', 'armGroupLabels': ['Part 1: Image Optimization Group', 'Part 2A: Prospective imaging (Stereotactic body radiotherapy (SBRT) Participants)', 'Part 2B: Prospective imaging (High-risk localized prostate cancer)', 'Part 3: SBRT participants at time of biochemical recurrence (BCR)']}, {'name': 'Non-interventional hormone therapy', 'type': 'BIOLOGICAL', 'otherNames': ['Non-interventional, systemic hormone therapy'], 'description': 'Therapy given outside of this study as part of standard of care', 'armGroupLabels': ['Part 2B: Prospective imaging (High-risk localized prostate cancer)']}, {'name': 'Prostate Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Biopsy'], 'description': "Biopsies may be taken from Trans-rectal ultrasound (TRUS) -visible lesion at the urologist's discretion", 'armGroupLabels': ['Part 3: SBRT participants at time of biochemical recurrence (BCR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Louise Magat', 'role': 'CONTACT', 'email': 'Louise.Magat@ucsf.edu', 'phone': '415-502-1822'}, {'role': 'CONTACT', 'email': 'cancertrials@ucsf.edu', 'phone': '877-827-3222'}, {'name': 'Robert Bok, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anthony Wong, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Louise Magat', 'role': 'CONTACT', 'email': 'Louise.Magat@ucsf.edu', 'phone': '(415) 502-1822'}], 'overallOfficials': [{'name': 'Robert Bok, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Bok, MD, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert Bok, MD, PhD', 'investigatorAffiliation': 'University of California, San Francisco'}}}}