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

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

View trial on ClinicalTrials.gov


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