Multiparametric MRI for Prostate Cancer Localization and Characterization Using Hyperpolarized Pyruvate (13C) Injection

• Status: Withdrawn
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

Prostate cancer is the most common malignancy among men in the United States and Canada. Suspicion of prostate cancer with modern screening tests, such as digital rectal exam (DRE) and prostate serum antigen (PSA) require ultrasound-guided biopsy for pathological diagnosis. However, this technique misses cancer in nearly one quarter of patients and finds clinically insignificant disease in another third of patients, resulting in over-treatment and unnecessary morbidity.

MRI is the best imaging method for prostate cancer detection, but current techniques cannot reliably predict tumour grade and are often unreliable for localizing cancer, particularly within the transition zone, where specificity is low. The primary objective of this pilot study is to evaluate the added benefit of localizing prostate cancer and predicting tumour grade with Hyperpolarized 13C MRI, in addition to traditional T2-weighted and diffusion-weighted MR imaging.

The investigators propose a pilot study, in men diagnosed with prostate cancer awaiting prostatectomy, with the specific goals of comparing pre-operative imaging findings to ground truth histology, using whole-mount prostate specimens. The results of this study will provide insight into the prostate cancer disease signatures with MRI and determine if there is added benefit for incorporation of this new technique into future clinical MRI protocols. If future imaging tests could determine the size, grade and extent of disease, this would open the door for less invasive, localized treatment options with reduced morbidity.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre

Criteria

Inclusion Criteria:

• Absolute neutrophil count (ANC) ≥1500 cells/µl

• Hemoglobin ≥9.0 gm/dL

• Platelets ≥100,000 cells/µL

• Estimated creatinine clearance* ≥60 mL/min

• by the Cockcroft Gault equation

• Bilirubin within normal range

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within normal range

• Negative test for hepatitis B and hepatitis C

• Eastern Cooperative Oncology Group Status of 0 or 1

Exclusion Criteria:

• Unable to give valid informed consent

• Contraindications to MRI or MRI contrast agents

• A high risk factor for nephrogenic systemic fibrosis (NFS), including being on dialysis

• Suffering from heart disease, diabetes, single kidney, hypertension/hypotension, a history of renal disease, multiple myeloma, peripheral vascular disease

• Taking specific medications (loop diuretics, NSAIDs, aminoglycosides, vancomycin, amphotericin B or immunosuppressants)

• Claustrophobia

• Prior hormonal or radiation therapy for prostate cancer

• Active prostatitis, moderate to severe rectal inflammation, previous rectal surgery, or prostate biopsy within 12 weeks of planned MRI

• Currently or previously taking androgen deprivation therapy (however, use of a 5-α reductase inhibitor is allowed, provided it was discontinued at least 1 month prior to and 1 month following study entry)

• Have received, or are scheduled to receive, another IMP from 1 month prior to 1 month after inclusion in this study

• BMI of less than 18.5 or greater than 32

• Congestive heart failure, a past or present medical history of clinically significant electrocardiogram (EKG) abnormalities, which may include QT prolongation, a family history of prolonged QT interval syndrome, or a myocardial infarction (MI) within the past 12 months with ensuing unstable EKG, or ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year