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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076503
• Other study ID #: 2013/1513
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: January 3, 2018
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: January 2018
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Aggression
• Prostatic Neoplasms

Intervention

Procedure:
• PET-MR 18f-FACBC

• histology (gold standard)
histopathological classification of co-located dissected lymph nodes

Locations

Country	Name	City	State
Norway	Dept Urologic Surgery, St Olavs Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian Cancer Society, Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Elschot M, Selnæs KM, Sandsmark E, Krüger-Stokke B, Størkersen Ø, Tessem MB, Moestue SA, Bertilsson H, Bathen TF. A PET/MRI study towards finding the optimal [(18)F]Fluciclovine PET protocol for detection and characterisation of primary prostate cancer. E — View Citation

Selnæs KM, Krüger-Stokke B, Elschot M, Willoch F, Størkersen Ø, Sandsmark E, Moestue SA, Tessem MB, Halvorsen D, Kjøbli E, Angelsen A, Langørgen S, Bertilsson H, Bathen TF. (18)F-Fluciclovine PET/MRI for preoperative lymph node staging in high-risk prosta — View Citation

Outcome

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