Choline PET/CT and MRI for Targeted Prostate Biopsy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01751737

Enrollment

Registered

2012-12-18

Start date

2012-11-30

Completion date

2017-06-30

Last updated

2019-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate, cancer, biopsy, 18F-choline, PET, MRI

Brief 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.

Detailed description

This is an explorative diagnostic basic research study to assess the value of 18F-choline PET/CT and multi-sequence MRI for prostate cancer in patients undergoing diagnostic prostate biopsy. Patients will receive image-guided (targeted) prostate biopsies and metabolomic profiling of prostate biopsy tissues to evaluate underlying metabolic changes in comparison with pathological Gleason grading.

Interventions

PROCEDUREProstate Cancer Imaging

After imaging is completed, subjects will be scheduled for a prostate biopsy performed as part of their clinical care. If the imaging has identified suspicious lesions in the prostate, these regions will be made visible for the Urologist to be targeted for additional biopsies. These additional biopsies will undergo histological evaluation and further metabolomic testing to better understand metabolic differences between various grades of prostate cancer lesions.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	4 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026