Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Neoplasm Metastasis
  • Prostatic Neoplasms
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Younger than 125 years
Gender
Only males

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 sy...

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 (ISUP grade group 4 or higher) will be examined with PSMA PET/MRI and PET/CT. Of these 80 patients, 60 will be men who are scheduled for radical prostatectomy with extended pelvic lymph node dissection (ePLND) (surgery cohort) and 20 will be men who are scheduled for radiation treatment 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.

Tracking Information

NCT #
NCT04790968
Collaborators
  • St. Olavs Hospital
  • Haukeland University Hospital
  • University Hospital of North Norway
Investigators
Study Director: Øystein Risa, Prof Norwegian University of Science and Technology, NTNU Study Director: Morten Troøyen, MD St. Olavs Hospital