Prostate Cancer Clinical Trial

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

Summary

This pilot clinical trial studies how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon C13 pyruvate works in finding prostate cancer that exhibits poorly differentiated or undifferentiated cells (high-grade) and that is restricted to the site of origin, without evidence of spread (localized) in patients undergoing radical prostatectomy. Diagnostic procedures, such as MRSI with hyperpolarized carbon C13 pyruvate, may aid in the diagnosis of prostate cancer and in discriminating high-grade from low-grade prostate cancer and benign adjacent prostate tissue

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Full Description

PRIMARY OBJECTIVE:

I. To investigate the association between hyperpolarized (HP) pyruvate-to-lactate conversion (kPL) and HP urea perfusion with histologic grade of prostate cancer, including benign prostate tissue, low grade disease (primary Gleason score < 4), and high grade (primary Gleason score >= 4) prostate cancer.

SECONDARY OBJECTIVES:

I. Safety. II. To determine the optimal cut-off value of peak lactate to pyruvate ratio (lac/pyr), lac/pyr area under the curve (AUC), 13C pyruvate to lactate (kPL) rate, urea AUC, and urea transfer constant (ktrans) on magnetic resonance imaging (MRI) that accurately detects primary Gleason 4 component cancer.

III. To determine the reproducibility of peak lac/pyr, lac/pyr AUC and kPL, urea AUC and urea ktrans with same-day repeated dose studies. with same-day repeated dose studies.

IV. To compare peak lac/pyr, lac/pyr AUC and kPL, urea AUC, urea ktrans on MRI with Prostate Imaging-Reporting and Data System (PI-RADS) assessment of multiparametic MRI in predicting regions of cancer versus benign tissue.

EXPLORATORY OBJECTIVES:

I. To correlate histologic markers, including lactate dehydrogenase A (LDHA) expression and activity level, along with Ki-67, MYC, and MCT 1 and 4 expression, with peak intra-tumoral lac/pyr ratio, lactate AUC, and kPL detected using anatomically aligned magnetic resonance (MR) cross-sectional images of the prostate gland.

II. To test for an association between mean intra-tumoral lac/pyr signal and lactate AUC, kPL, urea AUC, and urea ktrans with adverse clinical and pathologic characteristics including extracapsular extension, positive nodal involvement, and failure to achieve undetectable prostate specific antigen (PSA) nadir following prostatectomy.

OUTLINE:

Patients receive hyperpolarized carbon C 13 pyruvate and urea C-13 intravenously (IV) and undergo MRSI within 12 weeks before undergoing radical prostatectomy. Patients may receive optional second hyperpolarized carbon C 13 pyruvate injection and undergo MRSI within 15-60 minutes after first scan.

After completion of study, patients are followed up at 24 hours.

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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; a minimum of 20 patients 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
Planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/MRSI
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) >= 1500 cells/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:

Patients who because of general medical or psychiatric condition or physiologic status cannot give valid informed consent
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
Patients who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients 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; no limit on number of prior prostate biopsies; prior transurethral prostatic resection (TURP) is not allowed
Current or prior androgen deprivation therapy; a history of use of a 5-alpha 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; 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

Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

38

Study ID:

NCT02526368

Recruitment Status:

Active, not recruiting

Sponsor:

University of California, San Francisco

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There is 1 Location for this study

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University of California, San Francisco
San Francisco California, 94143, United States

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Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

38

Study ID:

NCT02526368

Recruitment Status:

Active, not recruiting

Sponsor:


University of California, San Francisco

How clear is this clinincal trial information?

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