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
• Start date: February 6, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostatic Neoplasms
• 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

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

External Links

•   MD Anderson Cancer Center Website