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NCT03581500 Clinical Trial

Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Predicting Treatment Response in Patients With Prostate Cancer

Prostate Adenocarcinoma Clinical Trial

Official title:
Hyperpolarized 13-C-Pyruvate Magnetic Resonance Spectroscopic Imaging Reproducibilty Pilot in Patients With Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03581500
Other study ID # 2017-0403
Secondary ID NCI-2018-0109620
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date February 6, 2019
Est. completion date July 31, 2024

Study information
Verified date December 2023
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Hyperpolarized Carbon C 13 Pyruvate
Given IV
Procedure:
• Magnetic Resonance Spectroscopic Imaging
Undergo MRSI

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reproducibility of the key performance indicator Up to 3 years
Secondary 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. Up to 3 years
Secondary 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. Up to 3 years
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