Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients with Prostate Cancer on Active Surveillance
This phase II trial studies the side effects of hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) and to see how it works in monitoring patients with prostate cancer on active surveillance who have not received treatment. Diagnostic procedures, such as MRI, may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells.
Inclusion Criteria
- The participant has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by University of California San Francisco-Cancer of the Prostate Risk Assessment (UCSF-CAPRA) scoring at study entry
- For Part 1: Patient planning to enroll or currently on active surveillance; For Part 2: Currently enrolled on active surveillance with planned fusion biopsy within 12 weeks following completion of baseline HP C-13 pyruvate/mpMRI on study
- The participant 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
- Age ≥ 18 years old at the time of study entry
Exclusion Criteria
- Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry
- Patients unwilling or unable to undergo MR imaging, including patients with contraindications 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 * The use of an endorectal coil may be waived at the discretion of the principal investigator upon review of available imaging with radiology, in which case this exclusion criterion will not apply
- Patients with contra-indications to injection of gadolinium contrast; for example, patients with prior documented allergies 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
- Current or prior androgen deprivation therapy including luteinizing hormone-releasing hormone (LHRH) analogue or oral anti-androgen therapy. Previous use of a 5 alpha reductase inhibitor is allowed, provided it was discontinued at least 28 days prior to baseline C-13 HP pyruvate MRI
- Prior radiation treatment of the prostate
- Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI
- Poorly controlled hypertension, with blood pressure at study entry > 160 mm Hg systolic or > 100 mm Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted
- Congestive heart failure with New York Heart Association (NYHA) status >= 2
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03933670.
Locations matching your search criteria
United States
California
San Francisco
PRIMARY OBJECTIVES:
I. Optimize the imaging sequences that maximize signal-to-noise ratio (SNR) and intra-tumoral conversion of HP 13C pyruvate to lactate (kPL) and HP 13C pyruvate to glutamate (kPG) in regions of tumor versus (vs.) adjacent benign tissue as assessed by multi-parametric MRI (mpMRI) imaging characteristics. (Part 1)
II. Determine the association between intra-tumoral kPL and kPG with Gleason grade determined during magnetic resonance (MR)/ultrasound (US)-guided fusion prostate biopsies obtained within 12 weeks following baseline HP C-13 pyruvate MR exam. (Part 2)
SECONDARY OBJECTIVES:
I. Evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated dose studies.
II. Determine the association between peak intra-tumoral kPL observed on baseline imaging with serum prostate specific antigen (PSA).
III. Compare and contrast intra-tumoral kPL and kPG with prostate imaging reporting and data system (PI-RADS) version 2 and individual mpMRI parameters including apparent diffusion coefficient (ADC) on diffusion-weighted imaging.
IV. Describe the frequency of up-grading of tumor with MR/US-guided fusion biopsy obtained following baseline HP C-13 MR exam.
V. Further characterize the safety profile of HP C-13 pyruvate injections.
EXPLORATORY OBJECTIVES:
I. Correlate peak intra-tumoral kPL with results of gene expression profiling using DECIPHER assay.
II. Correlate peak intra-tumoral kPL and kPG with DECIPHER GRID tumor ribonucleic acid (RNA) expression of relevant components of the glycolytic pathway including lactate dehydrogenase (LDH), pyruvate dehydrogenase (PDH), aconitate hydratase (aconitase),MYC, MCT4 (lactate transporter).
III. For patients who undergo optional follow-up HP C-13 pyruvate/MRI 6-15 months following baseline scan, determine the mean percent change from baseline in intra-tumoral kPL and kPG and whether the change from baseline is associated change in clinical risk assessment as determined by University of California, San Francisco (UCSF)-Cancer of the Prostate Risk Assessment (CAPRA) risk score.
OUTLINE:
Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than one minute, then undergo magnetic resonance spectroscopic imaging (MRSI) after 1-2 minutes. Within 15-60 minutes, patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI. Patients also undergo MR/US fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI. In addition, patients undergo collection of blood samples throughout the study.
After completion of study, patients are followed up at 12 months or based on investigator discretion.
Trial PhasePhase II
Trial Typediagnostic
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorIvan De Kouchkovsky
- Primary ID175516
- Secondary IDsNCI-2018-02195, 17-24246
- ClinicalTrials.gov IDNCT03933670