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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

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Pyruvate (13C) Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer
Actual Study Start Date : March 22, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Drug: Pyruvate (13C)
Pyruvate injection followed by a magnetic resonance imaging (MRI) scan.




Primary Outcome Measures :
  1. Difference in peak lactate/pyruvate conversion with histologic grade of prostate cancer [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Safety As measured by Adverse Events [ Time Frame: Up to 2 years ]
    As measured by Adverse Events

  2. Optimal cut-off value of lactate/pyruvate that accurately detects primary Gleason 4 component cancer. [ Time Frame: Baseline ]

Other Outcome Measures:
  1. To correlate histologic markers with peak intra-tumoral lactate/pyruvate ratio [ Time Frame: Baseline ]
  2. Mean intra-tumoral lac/pyr signal and lactate area under curve (AUC) with adverse clinical and pathologic characteristics [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526368


Contacts
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Contact: Rahul Aggarwal, MD (415) 353-9278 Rahul.Aggarwal@ucsf.edu
Contact: Paula Dutton (415) 885-7871 Paula.Dutton@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Rahul Aggarwal, MD    415-353-9278    Rahul.Aggarwal@ucsf.edu   
Contact: Paula Dutton, BS    415-885-7871    Paula.Dutton@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Rahul Aggarwal, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02526368     History of Changes
Other Study ID Numbers: 15557
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases