Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-05-31

Brief Summary

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Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment, accurate staging of the disease at the time point of diagnosis is important. The objective of this study is to evaluate the diagnostic potential of a combined PET/MR examination for risk assessment and detection of lymph node metastases. The overall aim of the project is to improve the investigators ability to provide individually tailored treatment to prostate cancer patients.

The study will include 32 men with high-risk prostate cancer, who are eligible for radical prostatectomy. Informed consent is a requirement for inclusion in the study.

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Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET-MR 18F-FACBC

Group Type EXPERIMENTAL

PET-MR 18f-FACBC

Intervention Type PROCEDURE

histology (gold standard)

Intervention Type PROCEDURE

histopathological classification of co-located dissected lymph nodes

Interventions

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PET-MR 18f-FACBC

Intervention Type PROCEDURE

histology (gold standard)

histopathological classification of co-located dissected lymph nodes

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* High-risk prostate cancer according to EAU guidelines (Gleason score ≥8 and/or PSA ≥20 ng/ml and/or ≥ cT3a cancer)
* Eligibility for the surgical procedure (radical prostatectomy and bilateral pelvic lymph node resection)

Exclusion Criteria

* Previous treatment (for example TURP or hormone therapy)
* Contraindication for the PET/MR examination (including, but not limited to: pacemaker, aneurysm clips, reduced renal function, metal implants, claustrophobia)

Eligible Sex

MALE

Accepts Healthy Volunteers

No