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

NCT02647983 | Withdrawn Phase 1

• 1 other identifier: 242-2014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Ability of the MRI machine to produce an image of the participant's prostate following an injection of Hyperpolarized Pyruvate (13C) as assessed by the physician

  Feasibility of acquiring time resolved, 3D 13C lactate images from subjects with prostate cancer.

  2 years

Secondary Outcomes (1)

• Ability of the MRI machine to aid in predicting Gleason grade following an injection of Hyperpolarized Pyruvate (13C) as assessed by the physician

  2 years

Study Arms (1)

Hyperpolarized Pyruvate (13C) Injection

EXPERIMENTAL

Hyperpolarized Pyruvate (13C) Injection to be used a MRI contrast agent.

Drug: Hyperpolarized Pyruvate (13C) Injection

Interventions

Hyperpolarized Pyruvate (13C) Injection DRUG

Hyperpolarized Pyruvate (13C) Injection is a MRI contrast agent.

Hyperpolarized Pyruvate (13C) Injection

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Charles Cunningham, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: January 6, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

CA (1)