A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer
Condition: Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT02526368
Sponsor: University of California, San Francisco
Phase: Early Phase 1
- Age: minimum 18 Years maximum N/A
- Gender: Male
- Biopsy-proven adenocarcinoma of the prostate. Biopsy may be performed outside of 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 University of California, San Francisco (UCSF) within 12 weeks following protocol MRI/magnetic resonance spectroscopic imaging (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.
- Adequate organ function, including absolute neutrophil count (ANC) ≥1500 cells/μL, hemoglobin ≥9.0 gm/dL, platelets ≥75,000 cells/μL, estimated creatinine clearance ≥50 mL/min (by the Cockcroft Gault equation), bilirubin <1.5x upper limit of normal (ULN) (unless Gilbert's is suspected), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <1.5x ULN.
- Patients who because of age less than 18 years old, 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 resection of the prostate (TURP) is not allowed.
- Current or prior androgen deprivation therapy. A history of use of a 5-α 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 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.
View trial on ClinicalTrials.gov