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

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ClinicalTrials.gov Identifier: NCT02526368
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE August 14, 2015
First Posted Date  ICMJE August 18, 2015
Last Update Posted Date October 23, 2018
Actual Study Start Date  ICMJE March 22, 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
Difference in peak lactate/pyruvate conversion with histologic grade of prostate cancer [ Time Frame: Baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02526368 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
  • Safety As measured by Adverse Events [ Time Frame: Up to 2 years ]
    As measured by Adverse Events
  • Optimal cut-off value of lactate/pyruvate that accurately detects primary Gleason 4 component cancer. [ Time Frame: Baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 19, 2018)
  • To correlate histologic markers with peak intra-tumoral lactate/pyruvate ratio [ Time Frame: Baseline ]
  • Mean intra-tumoral lac/pyr signal and lactate area under curve (AUC) with adverse clinical and pathologic characteristics [ Time Frame: Up to 2 years ]
Original Other Pre-specified Outcome Measures
 (submitted: August 14, 2015)
  • To correlate histologic markers with peak intra-tumoral lactate/pyruvate ratio [ Time Frame: Baseline ]
  • Mean intra-tumoral lac/pyr signal and lactate AUC with adverse clinical and pathologic characteristics [ Time Frame: Up to 2 years ]
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer
Official Title  ICMJE A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer
Brief Summary This is a pilot study evaluating pre-surgical patients with histologically confirmed localized prostate cancer who receive infusion with hyperpolarized pyruvate (13C) injection and undergo metabolic MR imaging with endorectal coil within 12 weeks of subsequent radical prostatectomy.
Detailed Description This is a pilot study evaluating pre-surgical patients with histologically confirmed localized prostate cancer who receive infusion with hyperpolarized pyruvate (13C) injection and undergo metabolic MR imaging with endorectal coil within 12 weeks of subsequent radical prostatectomy. At least 20 patients will be required to have high risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: Pyruvate (13C)
Pyruvate injection followed by a magnetic resonance imaging (MRI) scan.
Study Arms  ICMJE Experimental: Pre-surgical Prostate Cancer patients

A minimum of 20 patients will be required to have high-risk localized disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.

Magnetic Resonance (MR) scan using pyruvate (13C) injection prior to prostate surgery.Participants will remain monitored on the study until the time of your radical prostatectomy or 30 days after the pyruvate (13C) injection, whichever is longer.

Intervention: Drug: Pyruvate (13C)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Biopsy-proven adenocarcinoma of the prostate. Biopsy may be performed outside of 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 University of California, San Francisco (UCSF) within 12 weeks following protocol MRI/magnetic resonance spectroscopic imaging (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.
  • Adequate organ function, including absolute neutrophil count (ANC) ≥1500 cells/μL, hemoglobin ≥9.0 gm/dL, platelets ≥75,000 cells/μL, estimated creatinine clearance ≥50 mL/min (by the Cockcroft Gault equation), bilirubin <1.5x upper limit of normal (ULN) (unless Gilbert's is suspected), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <1.5x ULN.
  • For patients with partners of childbearing potential, willing to use adequate contraception for one month after undergoing hyperpolarized (HP) pyruvate infusion.

Exclusion Criteria:

  • Patients who because of age less than 18 years old, 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 resection of the prostate (TURP) is not allowed.
  • Current or prior androgen deprivation therapy. A history of use of a 5-α 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rahul Aggarwal, MD (415) 353-9278 Rahul.Aggarwal@ucsf.edu
Contact: Paula Dutton (415) 885-7871 Paula.Dutton@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02526368
Other Study ID Numbers  ICMJE 15557
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rahul Aggarwal, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP