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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02076503

Enrollment

Registered

2014-03-03

Start date

2014-04-30

Completion date

2015-05-31

Last updated

2018-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Keywords

Neoplasm Staging, Positron-Emission Tomography, Magnetic Resonance Imaging, 1-amino-3-fluorocyclobutane-1-carboxylic acid

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.

Interventions

PROCEDUREPET-MR 18f-FACBC

PROCEDUREhistology (gold standard)

histopathological classification of co-located dissected lymph nodes

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026