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

St. Olavs Hospital

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Procedure: PET-MR 18f-FACBC; Procedure: histology (gold standard)

Study type: Interventional

Funder types: Other

Identifiers

NCT02076503

2013/1513

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Male

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

PET-MR 18F-FACBC

Experimental group

Treatment:

Procedure: PET-MR 18f-FACBC

Procedure: histology (gold standard)