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

N/ACompletedNCT02076503

St. Olavs Hospital28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostatic Neoplasms

Interventions

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Positive and negative predictive value of 18FACBC PET/MR for detection of lymph node metastases

Findings on 18FACBC PET/MR images will be compared to histopathology, which is considered the gold standard for evaluation of pelvic lymph node metastases

Time frame: 7 days