Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients

August 14, 2023 updated by: Norwegian University of Science and Technology

For high-risk prostate cancer patients, detection of lymph node metastases is crucial to ensure optimal treatment.

Standard treatment for these patients is radiotherapy or surgery. The surgery involves resection of the prostate and the pelvic lymph nodes. Currently, the most reliable method to confirm lymph node metastases is by histologic examination of the resected lymph nodes. Ideally, one should be able to detect lymph node metastases prior to treatment. Then, the treatment could be better adjusted to each patient.

Imaging methods such as prostate specific membrane antigen positron emission tomography (PSMA-PET) can possibly aid the detection of lymph node metastases. In this study, the investigators want to test whether PSMA-PET or a combination of PSMA-PET and MRI (magnetic resonance imaging) can improve staging of lymph nodes before treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

High-risk prostate cancer patients have a high probability for lymph node metastases in the pelvic region. The lymph node status is an important prognostic factor in determining the risk of later relapses and a factor in treatment planning. Lymph node metastases outside the pelvis usually signify systemic treatment not amendable for curative treatment.

High-risk prostate cancer patients are treated by radiotherapy or surgical resection of the prostate and the pelvic lymph nodes. Currently, the most reliable method for confirming lymph node metastases is by bilateral pelvic lymph node dissection during surgical treatment, and subsequent histologic examination. However, todays state-of-the art methods for the detection of lymph node metastases prior to treatment are clearly inadequate. Detection of lymph node metastases is crucial for determining whether the patient (i) is a candidate for localized treatment and, if so, (ii) optimizing the extent of the lymph node dissection / radiation field for localized treatment. Non-standard imaging methods such as prostate specific membrane antigen (PSMA)-PET-imaging have been shown to be able to aid in the detection of lymph node metastases. The purpose of this study is to test whether PSMA-PET or a combination of PSMA-PET and MRI can improve the sensitivity and specificity for pre-treatment lymph node staging in order to reduce both over- and undertreatment of high-risk prostate cancer patients.

In this multi-centre study, at least 80 patients with high-grade prostate cancer (according to NCNN Guidelines, v 2.2022) will be examined with PSMA PET/MRI and PET/CT. Study recruitment will continue until 60 patients have received radial prostatectomy with extended pelvic lymph node dissection (ePLND) (surgery cohort) and 20 patients have been treated with radiotherapy to the prostate and pelvic lymph nodes (radiotherapy cohort). After the PET examinations, all patients will receive standard treatment and follow-up, which is determined by national guidelines and the patient's treating urologist and/or oncologist. Imaging data will be analyzed by radiologists and nuclear medicine physicians in collaboration. The imaging findings in the surgery cohort will be compared to the histology outcome after ePLND to assess the sensitivity and specificity for detection of lymph node involvement with PSMA PET/MRI. The data from the radiotherapy cohort will be used to assess the feasibility of PSMA PET/MRI-based radiotherapy planning. Advanced image processing and analysis methodology including the use of artificial intelligence will also be applied.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria (surgery cohort):

  • High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND; ISUP Gleason grade group ≥ 4

Inclusion criteria (radiotherapy cohort):

  • High-risk localized/locally advanced prostate cancer patients scheduled for radiation treatment of the prostate and pelvic lymph nodes; ISUP Gleason grade group ≥ 4

Exclusion criteria (surgery and radiotherapy cohort):

  • Prior history of any other cancer the last 5 years excluding basal cell carcinoma
  • Proven metastases in bones or other distant metastases
  • General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia)
  • Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives
  • Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PSMA-PET/MRI and PET/CT for detection of lymph node metastases.

Each patients will undergo an MRI-, PET/MRI- and PET/CT-examination (on the same day) prior to treatment.

Patients in the radiotherapy cohort will additionally undergo an MRI examination after hormonal treatment, before radiotherapy.
Diagnostic test: PSMA-PET
Prostate specific membrane antigen positron emission tomography
Diagnostic test: PSMA-PET/MRI
Prostate specific membrane antigen positron emission tomography combined with magnetic resonance imaging
Diagnostic test: PSMA-PET/CT
Prostate specific membrane antigen positron emission tomography combined with computed tomography imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI
Time Frame: 1 month
To compare the diagnostic accuracy of PSMA PET and combined PSMA PET/MRI to that of the current standard multiparametric MRI, using histopathology as the gold standard.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of PSMA PET/MRI
Time Frame: 1 month
To evaluate the sensitivity and specificity of PSMA PET/MRI to detect positive lymph nodes in high-risk prostate cancer patients in a prospective, multicenter study.
1 month
Performance of PSMA PET/MRI versus PET/CT
Time Frame: 1 month
Compare the performance of PET/MRI to PET/CT for detection of lymph node metastases
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

University Hospital of North Norway
Haukeland University Hospital
St. Olavs Hospital

Investigators

  • Study Director: Øystein Risa, Prof, Norwegian University of Science and Technology, NTNU
  • Study Director: Morten Troøyen, MD, St. Olavs Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 50719

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostatic Neoplasms

Clinical Trials on PSMA-PET

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe