Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status
Conditions
Prostatic Neoplasms
Conditions: official terms
Aggression - Prostatic Neoplasms
Conditions: Keywords
Neoplasm Staging, Positron-Emission Tomography, Magnetic Resonance Imaging, 1-amino-3-fluorocyclobutane-1-carboxylic acid
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Intervention
Name: PET-MR 18f-FACBC Type: Procedure
Name: histology (gold standard) Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Male
Criteria: 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)
Location
Dept Urologic Surgery, St Olavs Hospital
Trondheim, Norway
Status: Recruiting
Contact: Ola Dalsegg Saether, MD - +47 73868370 - ola.d.sether@ntnu.no
Start Date
April 2014
Completion Date
December 2015
Sponsors
St. Olavs Hospital
Source
St. Olavs Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page