San Francisco, California 94158


Purpose:

This is a pilot study evaluating pre-surgical patients with histologically confirmed localized prostate cancer who receive infusion with hyperpolarized pyruvate (13C) injection and undergo metabolic MR imaging with endorectal coil within 12 weeks of subsequent radical prostatectomy.


Study summary:

This is a pilot study evaluating pre-surgical patients with histologically confirmed localized prostate cancer who receive infusion with hyperpolarized pyruvate (13C) injection and undergo metabolic MR imaging with endorectal coil within 12 weeks of subsequent radical prostatectomy. At least 20 patients will be required to have high risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.


Criteria:

Inclusion Criteria: - 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 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. - 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 ULN (unless Gilbert's is suspected), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <1.5x ULN. - For patients with partners of childbearing potential, willing to use adequate contraception for one month after undergoing HP pyruvate infusion. Exclusion Criteria: - 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 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.


NCT ID:

NCT02526368


Primary Contact:

Principal Investigator
Rahul Aggarwal, MD
University of California, San Francisco

Rahul Aggarwal, MD
Phone: (415) 353-9278
Email: Rahul.Aggarwal@ucsf.edu


Backup Contact:

Email: Paula.Dutton@ucsf.edu
Paula Dutton
Phone: (415) 885-7871


Location Contact:

San Francisco, California 94158
United States

Rahul Aggarwal, MD
Phone: 415-353-9278
Email: Rahul.Aggarwal@ucsf.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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