Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Predicting Treatment Response in Patients With Prostate Cancer
Primary Purpose
Prostate Adenocarcinoma, PSA Level Greater Than Ten, Stage IIB Prostate Cancer AJCC v8
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized Carbon C 13 Pyruvate
Magnetic Resonance Spectroscopic Imaging
Sponsored by

About this trial
This is an interventional diagnostic trial for Prostate Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (hyperpolarized carbon C 13 pyruvate MRSI)
Arm Description
Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.
Outcomes
Primary Outcome Measures
Reproducibility of the key performance indicator
Secondary Outcome Measures
Sensitivity assessed by comparison to biopsy
The location of signal by hyperpolarized 13-C-pyruvate will be compared to location of tumor at biopsy or if available, follow-up surgical pathology in patients who did not receive interval additional prostate directed therapy, such as hormonal or radiation therapy.
Specificity assessed by comparison to biopsy
The location of signal by hyperpolarized 13-C-pyruvate will be compared to location of tumor at biopsy or if available, follow-up surgical pathology in patients who did not receive interval additional prostate directed therapy, such as hormonal or radiation therapy.
Full Information
NCT ID
NCT03581500
First Posted
June 27, 2018
Last Updated
October 13, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03581500
Brief Title
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Predicting Treatment Response in Patients With Prostate Cancer
Official Title
Hyperpolarized 13-C-Pyruvate Magnetic Resonance Spectroscopic Imaging Reproducibilty Pilot in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
PRIMARY OBJECTIVE:
I. To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including key performance indicator (kpl), which assesses the rate of conversion of 13-C pyruvate to 13-C lactate in the tissue of interest, using a test-retest study design.
SECONDARY OBJECTIVE:
I. To provide initial assessment of the sensitivity and specificity of hyperpolarized 13-C-pyruvate MRSI performed pre-therapy for detecting high risk localized prostate cancer.
OUTLINE:
Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20 seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.
After completion of study, patients are followed up at 1 day and then for up to 3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma, PSA Level Greater Than Ten, Stage IIB Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (hyperpolarized carbon C 13 pyruvate MRSI)
Arm Type
Experimental
Arm Description
Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized Carbon C 13 Pyruvate
Other Intervention Name(s)
Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Spectroscopic Imaging
Other Intervention Name(s)
1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, Proton Magnetic Resonance Spectroscopic Imaging
Intervention Description
Undergo MRSI
Primary Outcome Measure Information:
Title
Reproducibility of the key performance indicator
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Sensitivity assessed by comparison to biopsy
Description
The location of signal by hyperpolarized 13-C-pyruvate will be compared to location of tumor at biopsy or if available, follow-up surgical pathology in patients who did not receive interval additional prostate directed therapy, such as hormonal or radiation therapy.
Time Frame
Up to 3 years
Title
Specificity assessed by comparison to biopsy
Description
The location of signal by hyperpolarized 13-C-pyruvate will be compared to location of tumor at biopsy or if available, follow-up surgical pathology in patients who did not receive interval additional prostate directed therapy, such as hormonal or radiation therapy.
Time Frame
Up to 3 years
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tharakeswara Bathala, MBBS,MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Predicting Treatment Response in Patients With Prostate Cancer
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