Clinical trial NCT02911467 (phase 1, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: pyruvate (13c)
SMILES: CC(=O)C(O)=O
Reason stopped: 
    low accrual
  
Eligibility criteria:

        Inclusion Criteria:

          1. Biopsy-proven prostate cancer.

          2. Progressive, castration-resistant disease according to PCWG2 criteria.

          3. Planned treatment with an androgen signaling inhibitor (e.g., abiraterone,
             enzalutamide, apalutamide (ARN-509)). Patients must not be receiving androgen
             signaling inhibitor at the time of the baseline MR scan. Combination treatment (e.g.,
             androgen signaling inhibitor in conjunction with another systemic treatment) is
             allowed.

          4. Presence of at least one target lesion detected by standard staging scans that, in the
             judgment of Study Investigators, would be amenable to hyperpolarized C-13
             pyruvate/metabolic MR imaging:

               -  Soft tissue/visceral organ target lesions must measure at 1.5 cm in long axis
                  diameter on CT or MRI.

               -  Target lesions in the bone must be visualized by CT or MRI (lesions present only
                  on bone scan do not qualify).

               -  For patients with target lesion in prostate/prostatic bed:

                  i. No contra-indications to endorectal coil insertion (e.g., patients with a
                  prior abdominoperineal resection of the rectum or latex allergy).

             ii. No prior local treatment to the selected lesion. Patients who have received prior
             radiation or ablative therapy to the prostate will be required to have biopsy-proven
             evidence of disease recurrence following completion of local therapy.

          5. The subject is able and willing to comply with study procedures and provide signed and
             dated informed consent.

          6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

          7. Adequate organ function, including absolute neutrophil count (ANC) ≥ 1500 cells/µL,
             hemoglobin ≥ 9.0 gm/dL, platelets ≥ 75,000 cells/µL, creatinine < 1.5 x ULN or
             estimated creatinine clearance ≥ 50 mL/min (by the Cockcroft Gault equation),
             bilirubin <1.5x ULN (unless Gilbert's is suspected in which case total bilirubin < 3 x
             ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5x ULN.

          8. For patients undergoing optional tumor biopsy:

               -  No history of bleeding diathesis.

               -  Patients on anti-coagulation they must be able to safely stop treatment for
                  purposes of tumor biopsy.

          9. For patients with partners of childbearing potential, willing to use adequate
             contraception for one month after undergoing HP pyruvate infusion.

         10. Patients must have prior bilateral orchiectomy or be on continuous luteinizing-hormone
             releasing hormone (LHRH) analogue therapy for the duration of study.

         11. Castrate level of serum testosterone (< 50 ng/dL) at study entry.

        Exclusion Criteria:

          1. Patients who because of age, 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
             contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial
             vascular clips.

          3. Metallic hip implant or any other metallic implant or device that distorts local
             magnetic field and compromises the quality of MR imaging.

          4. Poorly controlled hypertension, defined as systolic blood pressure at study entry
             greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg. The
             addition of anti-hypertensives to control blood pressure is allowed.

          5. Congestive heart failure or New York Heart Association (NYHA) status ≥ 2.

          6. A history of clinically significant EKG abnormalities, including QT prolongation (QTcF
             > 500 ms), 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.

          7. Any condition that, in the opinion of the Principal Investigator, would impair the
             patient's ability to comply with study procedures.