Pilot Study of (MR) Imaging with Pyruvate (13C) to Detect High Grade Prostate Cancer

Launched by IVAN DE KOUCHKOVSKY, MD · Aug 14, 2015

Keywords

ClinConnect Summary

This clinical trial is exploring a new imaging technique to help detect high-grade prostate cancer, which is a more aggressive form of the disease. Researchers want to see how well a special type of MRI, called magnetic resonance spectroscopic imaging (MRSI), works when combined with a substance called hyperpolarized carbon 13 (13C) pyruvate. The goal is to identify cancer that is localized to the prostate and distinguish between high-grade cancer and less serious forms, as well as benign (non-cancerous) prostate tissue. This study is currently looking for men aged 65 to 74 who have been diagnosed with prostate cancer through a biopsy and are planning to have surgery to remove the prostate within the next three months.

To be eligible for this study, participants must have a specific type of prostate cancer confirmed by a biopsy and meet certain health criteria, such as having a good overall health status and normal blood counts. They must also be able to undergo MRI imaging and provide consent to participate. If you join the study, you will have an MRI scan to help assess your cancer before your scheduled surgery. It's important to note that certain medical conditions or previous treatments may prevent someone from participating. This trial offers a chance to contribute to research that could improve how prostate cancer is diagnosed and treated in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Biopsy-proven adenocarcinoma of the prostate. Biopsy may be performed outside of University of California, San Francisco (UCSF), if detailed results of sextant biopsy are available. For Cohort A only, a minimum of 20 participants out of a planned enrollment of 50 patients must have high-risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.
• • Cohort A only: Planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/MRSI.
• • Cohort B only: HIFU focal therapy completed within 18 months of protocol MRI/MRSI, and planned systematic and MR-guided biopsy at UCSF within 12 weeks following protocol MRI/MRSI.
• • 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
• • Absolute neutrophil count (ANC) \>= 1500 cells/microliter (uL)
• • Hemoglobin \>= 9.0 mg/dL
• • Platelets \>= 75,000 cells/uL
• • Estimated creatinine clearance \>= 50 mL/min (by the Cockcroft Gault equation)
• • Bilirubin \< 1.5 x upper limit of normal (ULN) (unless Gilbert's is suspected)
• • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 1.5 x ULN
• Exclusion Criteria:
• • Participants who because of age less than 18 years old, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
• • Participants unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
• • Participants who cannot tolerate or have contra-indications to endorectal coil insertion; for example, participants with a prior abdominoperineal resection of the rectum or latex allergy.
• • Patients with contra-indications to injection of gadolinium contrast; for example patients with prior documented allergy 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.
• • Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment. For Cohort B, HIFU focal therapy is allowed. No limit on number of prior prostate biopsies; prior transurethral prostatic resection (TURP) is not allowed.
• • Current or prior androgen deprivation therapy. For Cohort A, a history of use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry. For cohort B, a history of use of 5-α reductase inhibitor is allowed, provided it is discontinued at least 14 days to protocol MRI/MRSI.
• • Poorly controlled hypertension, with blood pressure at study entry \> 160/100; the addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
• • Congestive heart failure or New York Heart Association (NYHA) status \>= 2.
• • A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation, 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.