Prostate Cancer Clinical Trial

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

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).

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Full 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.

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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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

2

Study ID:

NCT03581500

Recruitment Status:

Active, not recruiting

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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M D Anderson Cancer Center
Houston Texas, 77030, United States

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Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

2

Study ID:

NCT03581500

Recruitment Status:

Active, not recruiting

Sponsor:


M.D. Anderson Cancer Center

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