sing advanced MRI to explore metabolism and tissue structure in prostate cancer

Not Applicable

• Conditions: Prostate cancer; Cancer

• Registration Number: ISRCTN15512854
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-08
• Last Update Posted: 5 August 2024
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 85

Inclusion Criteria

1. Men aged >18 years
2. For surgery or hormone therapy patients, biopsy-proven intermediate-risk or high-risk prostate cancer (Appendix 1), with a clinical treatment plan
3. Previous diagnostic clinical MRI demonstrates a visible tumour

Exclusion Criteria

1. Previous treatment for prostate cancer
2. Clinical contraindication to MRI
3. Renal impairment as defined by a glomerular filtration rate (GFR) <30 ml/min

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured by MRI before and after treatment:<br>1. 13C. Spatial maps of area under the curve (AUC) timecourse sums of signals from hyperpolarized pyruvate, lactate, and any other metabolites detected, and ratios between these metabolite AUCs. Also estimates of the kinetic rate constants of conversion between injected tracer pyruvate and the metabolites formed (lactate, other). The timecourse typically covers approximately 1 minute beginning approximately 16 seconds after the start of injection.<br>2. Sodium. Maps of estimated millimolar sodium content over the 3D volume of tissue investigated. Optionally also maps of the ratio of intracellular-weighted signal to total sodium signal.

Secondary Outcome Measures

Name	Time	Method
1. Levels of metabolites such as pyruvate, lactate in venous blood as measured by liquid chromatography mass spectrometry (LCMS) before and after treatment<br>2. Total activities of lactate dehydrogenase (LDH) in venous blood as measured by LDH assay before and after treatment<br>3. Levels of carbonic anhydrase IX, CD31, Hypoxia-Inducible Factor-1a (HIF-1a), Ki67, monocarboxylic acid (MCT1/4) transporters, LDH expression and lactate/pyruvate measured in prostatectomy or biopsy specimens by immunohistochemistry before and after treatment. Immunohistochemistry results will be converted into semi-quantitative data using an appropriate density measurement of staining.