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

Not Applicable

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Procedure: PET-MR 18f-FACBC; Procedure: histology (gold standard)

• Registration Number: NCT02076503
• Lead Sponsor: St. Olavs Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-27
• Study First Posted: 2014-03-03
• Study Start: 2014-04
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-03
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET-MR 18F-FACBC	PET-MR 18f-FACBC	-
PET-MR 18F-FACBC	histology (gold standard)	-

Primary Outcome Measures

Name	Time	Method
Positive and negative predictive value of 18FACBC PET/MR for detection of lymph node metastases	7 days	Findings on 18FACBC PET/MR images will be compared to histopathology, which is considered the gold standard for evaluation of pelvic lymph node metastases

Trial Locations

Locations (1)

Dept Urologic Surgery, St Olavs Hospital; 🇳🇴 Trondheim, Norway