Condition: Prostate Adenocarcinoma, Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03933670

Sponsor: University of California, San Francisco

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

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.

View trial on ClinicalTrials.gov