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RecruitingEarly Phase 1

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

A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, MRI scans, Biopsies, Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To investigate the association between HP pyruvate-to-lactate conversion (kPL) and HP urea perfusion with in-field clinically significant (Gleason score \>3+3) recurrent/residual prostate cancer following non-investigational High-Intensity Focused Ultrasound (HIFU) focal therapy (Cohort B) SECONDARY OBJECTIVES: I."
  • "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 (Cohort A)."
  • "To determine the optimal cut-off value of peak lac/pyr, lac/pyr AUC, kPL Urea AUC, Urea ktrans and kPL-urea product (kUP) on MRI that accurately detects in-field clinically significant (ie."
  • "To compare peak lac/pyr, lac/pyr AUC and kPL, urea AUC, urea transfer constant (ktrans) on MRI with Prostate Imaging-Reporting and Data System (PI-RADS) assessment of multiparametric MRI in predicting regions of cancer versus benign tissue."
  • "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."
  • "OUTLINE: Participants receive either hyperpolarized carbon pyruvate (13C) or co-polarized 13C pyruvate and 13C, 15N2urea intravenously (IV) and undergo MRSI within 12 weeks of undergoing non-investigational radical prostatectomy (cohort A) or non-investigational systematic and MR-targeted biopsies (cohort B)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a special MRI scan using carbon-13 pyruvate, alone or with carbon-13 nitrogen-15 urea, to find high-grade prostate cancer that has not spread. High-grade cancer has very abnormal cells. The study includes people planning prostate removal surgery and people who have had focused ultrasound treatment.

This pilot clinical trial studies how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon 13 (13C) pyruvate alone or in combination with 13C 15N2 Urea 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 (13C) pyruvate, may aid in the diagnosis of prostate cancer and in discriminating high-grade from low-grade prostate cancer and benign adjacent prostate tissue

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A biopsy (tissue sample) must show prostate adenocarcinoma, a type of prostate cancer. Biopsies done outside UCSF need detailed results.
  • Group A: Plan to have surgery to remove the prostate at UCSF within 12 weeks after the study scan.
  • Group A: At least 20 of the planned 50 people must have high-risk cancer, with a primary Gleason grade of 4 or 5 on an earlier biopsy.
  • Group B: Have had HIFU, a focused ultrasound treatment, within 18 months of the study scan.
  • Group B: Plan to have both standard and MRI-guided prostate biopsies at UCSF within 12 weeks after the study scan.
  • Be willing and able to follow study steps and sign and date a consent form.
  • Be fully active or able to do light work despite limits on hard physical activity.

Who can't join

  • Be under 18, or have a health or mental health condition that prevents valid consent.
  • Be unable or unwilling to have an MRI, or have an unsafe device, such as certain pacemakers or brain blood vessel clips. Metal implants that spoil the scan images also rule you out.
  • Be unable to have a scanning device placed in the rectum, for example because of past rectum removal or a latex allergy. The study doctor may waive this device requirement.
  • Be unable to receive gadolinium contrast dye, for example because of an allergy or poor kidney function.
  • Have had prostate freezing treatment, prostate cancer surgery, prostate or pelvic radiation, or TURP (surgery through the urine tube to remove prostate tissue). Group B may have had HIFU. Any number of past prostate biopsies is allowed.
  • Have current or past treatment to lower male hormones. Past use of a 5-alpha reductase inhibitor is allowed if stopped at least 1 month before study entry for Group A, or 14 days before the scan for Group B.
  • Have poorly controlled blood pressure above 160/100 at study entry. Blood pressure medicine may be added to help you qualify.
  • Have heart failure or a heart function rating of NYHA class 2 or higher; a history of important heart tracing (EKG) problems; a family history of long QT syndrome, a heart rhythm disorder; or a heart attack within 6 months. Atrial fibrillation or flutter is allowed if the heart rate is controlled.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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. Note: The use of an endorectal coil may be waived at the discretion of the Principal Investigator upon review of available imaging with radiology, in which case this exclusion criterion will not apply. * 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.

Study sites (1)

CA