Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance
Recruiting · NCT03933670 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
Hyperpolarized Carbon C 13 PyruvateMRI Ultrasound Fusion Guided BiopsyMagnetic Resonance Spectroscopic Imaging
What this trial is about
This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) 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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by 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 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) \>= 1000 cells/microliter (uL).
- Hemoglobin \>= 9.0 gm/deciliter (dL).
- Platelets \>= 75,000 cells/uL.
- Estimated creatinine clearance\* \>= 50 milliliter (mL)/min by the Cockcroft Gault equation.
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) or if =\< 3 x ULN if known/suspected Gilbert's
- Aspartate aminotransferase (AST) =\< 1.5 x ULN.
- Alanine aminotransferase (ALT) =\< 1.5 x ULN.
Exclusion criteria
- Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry.
- 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 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted.
- Congestive heart failure with New York Heart Association (NYHA) status \>= 2.
Where it is running
1 location listed across 1 US state.
- University of California, San Francisco - San Francisco, California, United States