A Pilot Study to Evaluate the Reproducibility of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) and Its Ability to Reflect Treatment Effects in Patients With Prostate Cancer
Condition: Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT02450201
Sponsor: University of California, San Francisco
Phase: Early Phase 1
- Age: minimum 18 Years maximum N/A
- Gender: Male
- 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.
View trial on ClinicalTrials.gov