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Investigation of the Magnitude of Uptake, Retention, and Spatial Distribution Pattern of 18F-Choline in Comparison With MRI and Histology Obtained From Prostate Cancer Biopsies


N/A
40 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Investigation of the Magnitude of Uptake, Retention, and Spatial Distribution Pattern of 18F-Choline in Comparison With MRI and Histology Obtained From Prostate Cancer Biopsies


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Morand R. Piert, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Hospital

Authority:

United States: Institutional Review Board

Study ID:

HUM00059514

NCT ID:

NCT01751737

Start Date:

November 2012

Completion Date:

December 2017

Related Keywords:

  • Prostate Cancer
  • prostate
  • cancer
  • biopsy
  • 18F-choline
  • PET
  • MRI
  • Prostatic Neoplasms

Name

Location

University of Michigan Health SystemsAnn Arbor, Michigan  48109