MRI With C13 Pilot Study Prostate Cancer
- Registration Number
- NCT02450201
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
This is a pilot clinical study of hyperpolarized pyruvate (13C) injection that includes the acquisition of magnetic resonance (MR) data and will be performed in men with localized prostate cancer. Part 1: Five patients will be evaluated for reproducibility of 13C HP MR imaging measurements obtained 2-3 weeks apart with no interim treatment. Part 2: Five patients will be evaluated for the change in 13C HP MR imaging measurements after 2 months of ADT.
13C HP MR data will be acquired in two parts of the study (which can occur simultaneously): Part 1: Patients will undergo imaging at baseline and will be repeated two to three weeks later (with no intervention in the interim) to evaluate reproducibility.
Part 2: Patients will undergo imaging at baseline, initiate androgen deprivation therapy, and undergo repeat imaging two months after initiation of ADT to evaluate the ability of the imaging to reflect a metabolic response to treatment.
The change in pyruvate/lactate ratio and lactate levels will be measured and compared to baseline at these timepoints.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 5
- The subject has biopsy-proven adenocarcinoma of the prostate with intermediate to high risk disease by UCSF CAPRA scoring and possesses a Gleason 4 component to the tumor. Subjects will be enrolled either prior to radical prostatectomy (N=5) or prior to 2 months of androgen deprivation therapy (LHRH agonist +/- antiandrogen) followed by definitive radiation therapy as their primary treatment for prostate cancer (N=5).
- The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
- At least 5 mm of tumor on biopsy (can have multiple cores to comprise 5 mm).
- The subject has concordant MRI/1H MRSI findings from a MR staging exam at UCSF performed prior to the 13C MRSI exam performed in this study with IMP, or is willing to undergo MRI/1H MRSI in connection with the study exam.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Laboratory criteria for protocol entry:
- Absolute neutrophil count (ANC) ≥1000 cells/µL
- Hemoglobin ≥9.0 gm/dL
- Platelets ≥75,000 cells/µL
- Estimated creatinine clearance ≥50 mL/min
- Total bilirubin ≤1.5x ULN (or if ≤4 gm/dL and direct bilirubin is WNL)
- Aspartate aminotransferase (AST) ≤1.5x ULN
- Alanine aminotransferase (ALT) ≤1.5x ULN
- Willing to use contraception during and for 1 month after completion of the study.
- For part 2 of the study: plans to initiate castrating therapy (with a GnRH antagonist, GnRH agonist, or orchiectomy). An antiandrogen may be started after initial imaging but can not be used prior to baseline imaging. An antiandrogen is allowed but not required.
- The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 month after inclusion in this study.
- Current or prior androgen deprivation therapy; previous 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.
- Contraindication for or inability to tolerate MRI examination.
- Prostate biopsy within 12 weeks prior to study entry.
- BMI of less than 18.5 or greater than 32. Subject body weight should be less than or equal to 100 kg owing to limitations in the amount of IMP available.
- 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) less than 1 year ago with ensuing unstable EKG.
- Ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1: Reproducibility Pyruvate Pyruvate injection followed by an MRI scan. 2-3 weeks after imaging #1: a second pyruvate injection followed by an MRI scan. Part 2: Treatment Response Pyruvate Pyruvate injection followed by an MRI scan. 2 months after imaging #1: a second pyruvate injection followed by an MRI scan.
- Primary Outcome Measures
Name Time Method Difference in peak lactate/pyruvate ratio Baseline and 2 months after 1st image
- Secondary Outcome Measures
Name Time Method Pyruvate area under the curve (AUC) Baseline and 2 months after 1st image Lactate area under the curve (AUC) Baseline and 2 months after 1st image Safety As measured by Adverse Events Up to 2 years As measured by Adverse Events
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States