Magnetic resonance imaging with hyperpolarized bicarbonate to measure tissue pH in localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-site pilot study will enroll 10 men with biopsy-proven localized prostate cancer who are scheduled for radical prostatectomy. Participants receive an infusion of hyperpolarized 13C bicarbonate and then undergo MR imaging with an endorectal coil to try to measure tissue pH in tumor and surrounding tissue. The study evaluates feasibility and safety of the imaging approach, and explores whether tissue pH relates to tumor grade and to molecular markers from tumor tissue. Participants are followed for 5–9 days after injection or until study-related events resolve or until new cancer therapy starts. The study is conducted at UCSF with collaboration from Bristol Myers Squibb and the U.S. Army MRAA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients age \>=18 years.
2. Patients must have 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.
3. Tumor size of at least 1.0 cm in long axis on Magnetic resonance imaging (MRI) or ultrasound; if no prior imaging is available, at least 3 cores positive on biopsy.
4. Patients must have planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/ magnetic resonance spectroscopy imaging) (MRSI).
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
6. Demonstrates adequate organ function as defined below:

   1. Adequate bone marrow function:

      * Absolute neutrophil count \>=1,500 cells/µL.
      * Platelets \>=75,000 cells/µL.
      * Hemoglobin \>=9.0 gm/dL.
   2. Adequate hepatic function:

      * Total bilirubin \<1.5x upper limits of normal (ULN) (within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).
      * Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) \<=1.5 X institutional upper limit of normal.
      * Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \<=1.5 X institutional upper limit of normal.
   3. Adequate renal function:

      * Creatinine clearance \>= 50 calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2.
7. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients who because of general medical or psychiatric condition, or physiologic status, cannot give valid informed consent.
2. Patients unwilling or unable to undergo MR imaging, including patients with contraindications to Magnetic resonance imaging (MRI) as per UCSF radiology departmental guidelines.
3. 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.
4. Patients with contra-indications to injection of gadolinium contrast as per UCSF radiology departmental guidelines.
5. Patients who take carbonic anhydrase inhibitors (e.g. acetazolamide, dichlorphenamide, methazolamide).
6. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.
7. 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.
8. 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.
9. Congestive heart failure or New York Heart Association (NYHA) status \>= 2. A history of clinically significant electrocardiogram (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.

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Robert Flavell, MD, PhD — University of California, San Francisco
• Study coordinator: Maya Aslam
• Email: Maya.Aslam@ucsf.edu
• Phone: (415) 514-8987

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.