Study Stopped
Committee could not find that the regulatory approval are met to re-approve this study.
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Predicting Treatment Response in Patients With Prostate Cancer
Hyperpolarized 13-C-Pyruvate Magnetic Resonance Spectroscopic Imaging Reproducibilty Pilot in Patients With Prostate Cancer
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
This phase II trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance spectroscopic imaging works in predicting treatment response in patients with prostate cancer. Hyperpolarized carbon C 13 pyruvate magnetic resonance spectroscopic imaging may help to accurately predict how prostate cancer patients will respond to standard therapy (abiraterone and apalutamide).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2019
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2018
CompletedFirst Posted
Study publicly available on registry
July 10, 2018
CompletedStudy Start
First participant enrolled
February 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2024
CompletedApril 23, 2025
October 1, 2024
5.7 years
June 27, 2018
April 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Reproducibility of the key performance indicator
Up to 3 years
Secondary Outcomes (2)
Sensitivity assessed by comparison to biopsy
Up to 3 years
Specificity assessed by comparison to biopsy
Up to 3 years
Study Arms (1)
Diagnostic (hyperpolarized carbon C 13 pyruvate MRSI)
EXPERIMENTALPatients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.
Interventions
Given IV
Undergo MRSI
Eligibility Criteria
You may qualify if:
- Biopsy proven high risk prostate adenocarcinoma, or de novo metastatic previously untreated naive prostate cancer (patients who have initiated gonadotrophin releasing hormone \[Lhrh\] analog or antagonist within the past 4 weeks are eligible)
- Gleason \>= 8 OR Gleason 7 + \>= cT2b + prostate specific antigen (PSA) \> 10 ng/ml
- Prior prostate biopsy must have been performed at least 4 weeks prior
You may not qualify if:
- Contraindication to MRI
- Estimated glomerular filtration rate (eGFR) \< 30
- Allergy to gadavist intravenous contrast
- History of cardiac arrhythmia
- Since they do not get prostate cancer, women are excluded; thus, pregnancy is not an issue
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tharakeswara Bathala, MBBS,MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2018
First Posted
July 10, 2018
Study Start
February 6, 2019
Primary Completion
October 16, 2024
Study Completion
October 16, 2024
Last Updated
April 23, 2025
Record last verified: 2024-10