Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance

Официальное название

A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) in Patients With Prostate Cancer on Active Surveillance

Обзор

This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring patients with prostate cancer on active surveillance who have not received treatment. Diagnostic procedures, such as MRI, may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells.

Подробное описание

PRIMARY OBJECTIVES:

I. Optimize the imaging sequences that maximize signal-to-noise ratio (SNR) and intra-tumoral conversion of HP 13C pyruvate to lactate (kPL) and HP 13C pyruvate to glutamate (kPG) in regions of tumor versus (vs.) adjacent benign tissue as assessed by multi-parametric MRI (mpMRI) imaging characteristics. (Part 1) II. Determine the association between intra-tumoral kPL and kPG with Gleason grade determined during magnetic resonance (MR)/ultrasound (US)-guided fusion prostate biopsies obtained within 6 months following baseline HP C-13 pyruvate MR exam. (Part 2)

SECONDARY OBJECTIVES:

I. Evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated dose studies.

II. Determine the association between peak intra-tumoral kPL observed on baseline imaging with serum prostate specific antigen (PSA).

III. Compare and contrast intra-tumoral kPL and kPG with prostate imaging reporting and data system (PI-RADS) version 2 and individual mpMRI parameters including apparent diffusion coefficient (ADC) on diffusion-weighted imaging.

IV. Describe the frequency of up-grading of tumor with MR/US-guided fusion biopsy obtained following baseline HP C-13 MR exam.

V. Further characterize the safety profile of HP C-13 pyruvate injections.

EXPLORATORY OBJECTIVES:

I. Correlate peak intra-tumoral kPL with results of gene expression profiling using DECIPHER assay.

II. Correlate peak intra-tumoral kPL and kPG with DECIPHER GRID tumor ribonucleic acid (RNA) expression of relevant components of the glycolytic pathway including lactate dehydrogenase (LDH), pyruvate dehydrogenase (PDH), aconitate hydratase (aconitase), myelocytomatosis oncogene (MYC), monocarboxylate transporter 4 (MCT4) (lactate transporter).

III. For patients who undergo optional follow-up HP C-13 pyruvate/MRI 6-15 months following baseline scan, determine the mean percent change from baseline in intra-tumoral kPL and kPG and whether the change from baseline is associated change in clinical risk assessment as determined by University of California, San Francisco (UCSF)-Cancer of the Prostate Risk Assessment (CAPRA) risk score.

OUTLINE:

Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than one minute, then undergo magnetic resonance spectroscopic imaging (MRSI) after 1-2 minutes. Within 15-60 minutes, patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI. Patients also undergo MR/US fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI.

After completion of study, patients will be followed up periodically.

Вмешательства

• Препарат Hyperpolarized Carbon C 13 Pyruvate
  Given IV
• Процедура Magnetic Resonance Spectroscopic Imaging
  Undergo MRSI
• Процедура MRI Ultrasound Fusion Guided Biopsy
  Undergo MR/US fusion-guided prostate biopsy

Первичные конечные точки

• Signal-to-noise ratio (SNR) of hyperpolarized lactate [Срок оценки: At Baseline]
• Intra-tumoral C-pyruvate to lactate (kPL) [Срок оценки: At Baseline]
• Intra-tumoral C-pyruvate to glutamate (kPG) [Срок оценки: At Baseline]
• Association between intra-tumoral C-pyruvate to lactate (kPL) with Gleason grade [Срок оценки: Within 12 weeks following baseline HP C-13 pyruvate MR exam]
• Association between intra-tumoral C-pyruvate to glutamate (kPG) with Gleason grade [Срок оценки: Within 12 weeks following baseline HP C-13 pyruvate MR exam]

Вторичные конечные точки (7)

• Intra-patient variability in kPL [Срок оценки: Up to 15 months]
• Intra-patient variability in kPG [Срок оценки: Up to 15 months]
• Contrast between kPL and kPG in regions of tumor [Срок оценки: Up to 15 months]
• Comparison of kPL and kPG with apparent diffusion coefficient in region of tumor [Срок оценки: Up to 15 months]
• Incidence of adverse events graded [Срок оценки: Up to 15 months]
• Association between peak intra-tumoral kPL observed on baseline imaging with serum PSA [Срок оценки: At Baseline]
• Describe frequency of up-grading of tumor [Срок оценки: Within 12 weeks following baseline HP C-13 pyruvate MR exam]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT03933670 · 175516 · R01CA211150 · R01EB017449 · U01CA232320-01A1 · R01CA300053 · NCI-2018-02195

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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