Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: Male

Summary

This pilot clinical trial studies how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon C13 pyruvate works in finding prostate cancer that exhibits poorly differentiated or undifferentiated cells (high-grade) and that is restricted to the site of origin, without evidence of spread (localized) in patients undergoing radical prostatectomy. Diagnostic procedures, such as MRSI with hyperpolarized carbon C13 pyruvate, may aid in the diagnosis of prostate cancer and in discriminating high-grade from low-grade prostate cancer and benign adjacent prostate tissue

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

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: American Cancer Society, Inc.; National Cancer Institute (NCI); National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Treatments: Carbamide Peroxide

Criteria

Inclusion Criteria:

• Biopsy-proven adenocarcinoma of the prostate; biopsy may be performed outside of University of California San Francisco (UCSF), if detailed results of sextant biopsy are available; a minimum of 20 patients out of a planned enrollment of 50 patients must have high-risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy

• Planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/MRSI

• The subject is able and willing to comply with study procedures and provide signed and dated informed consent

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Absolute neutrophil count (ANC) >= 1500 cells/uL

• Hemoglobin >= 9.0 mg/dL

• Platelets >= 75,000 cells/uL

• Estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation)

• Bilirubin < 1.5 x upper limit of normal (ULN) (unless Gilbert's is suspected)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 x ULN

Exclusion Criteria:

• Patients who because of general medical or psychiatric condition or physiologic status cannot give valid informed consent

• Patients unwilling or unable to undergo MR imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips

• Patients who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients with a prior abdominoperineal resection of the rectum or latex allergy

• Patients with contra-indications to injection of gadolinium contrast; for example patients with prior documented allergy or those with inadequate renal function

• Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging

• Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment; no limit on number of prior prostate biopsies; prior transurethral prostatic resection (TURP) is not allowed

• Current or prior androgen deprivation therapy; a history of use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry

• Poorly controlled hypertension, with blood pressure at study entry > 160/100; the addition of anti-hypertensives to control blood pressure is allowed for eligibility determination

• Congestive heart failure or New York Heart Association (NYHA) status >= 2

• A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry; patients with rate-controlled atrial fibrillation/flutter will be allowed on study