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

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dept Urologic Surgery, St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PET-MR 18f-FACBC

Procedure

histology (gold standard)

Procedure

histopathological classification of co-located dissected lymph nodes

Primary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

Norwegian Cancer Society
Norwegian University of Science and Technology

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 3, 2014
Registry last updated: Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed