CompletedNot Applicable

Choline PET/CT and MRI for Targeted Prostate Biopsy

United States63 participantsStarted 2012-11

Plain-language summary

This research study will access the using of a radiotracer, 18F-choline PET/CT and MRI for prostate cancer in patients undergoing diagnostic prostate biopsy. Patients receive MRI guided prostate biopsies and metabolomic profiling of prostate biopsy tissues.

Who can participate

Age range40 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males 40 years of age or older scheduled for prostate biopsy (for known or suspected prostate cancer) followed by planned prostatectomy (population group A) * Males 40 years of age or older with known (biopsy-confirmed) primary adenocarcinoma of the prostate undergoing active surveillance scheduled for prostate biopsy (population group B) Exclusion Criteria: * Androgen ablation (hormone treatment) within the last 3 months * Prostate biopsy within 6 weeks prior to PET or MRI imaging * Active inflammatory bowel disease within the last 6 months * Acute prostatitis within the last 6 months * A non-urologic bacterial infection requiring active treatment with antibiotics * Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years * Previous radiation treatment of the pelvis * Symptomatic distal rectal stenosis * Known hypersensitivity to glucagon * Pheochromocytoma, insulinoma or galactosemia * Insulin-dependent diabetes

What they're measuring

Evaluation whether the odds of primary Gleason ≥ 3+4 are greater for image-guided biopsy (based on parametric PET/MRI) than for non-image-guided (standard) biopsy.

Timeframe: 4 years

Trial details

NCT IDNCT01751737

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06

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