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PSMA-PET and MRI for Detection of Recurrent Prostate Cancer After Radical Treatment

NCT04298112 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-11-15

No results posted yet for this study

Summary

Approximately one third of prostate cancer patients experience biochemical relapse following initial radical prostatectomy or curative radiotherapy. To determine further treatment, it is of utmost importance to accurately differentiate local and regional recurrence from distant metastatic disease. Unfortunately, the currently used medical imaging methods (MRI and bone scan) lack sensitivity for detection of nodal and skeletal metastases, which can lead to over-treatment of patients with occult metastatic disease. PET imaging with prostate specific membrane antigen (PSMA)-ligands has shown a promising potential for improving the detection accuracy in recurrent prostate cancer, especially when combined with the excellent soft-tissue contrast of MRI. However, evidence is mostly based on retrospective single center studies so far, including patients with a wide variety of PSA levels.

Improving the sensitivity for detection of metastatic disease is a crucial step in reducing over-treatment of prostate cancer patients with biochemical relapse following radical treatment. The purpose of this prospective multi-center study is to standardize PSMA PET/CT and PET/MRI imaging across three university hospitals in Norway, and investigate its merit for detection of recurrent prostate cancer. The long-term overall goal is offering prostate cancer patients a more personalized treatment plan aiming to improve the chances of survival and quality of life.

Conditions

  • Prostatic Neoplasms

Interventions

DIAGNOSTIC_TEST

PSMA PET/CT

Whole-body PET/CT (contrast enhanced CT or low-dose CT); from vertex to thighs.

DIAGNOSTIC_TEST

PSMA PET/MR

Pelvic PET/MR in addition to targeted PET/MR according to other findings from the PET/CT (e.g. columna)

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Øystein Risa, phd · NTNU, Fac of Med and Health Sci, Dept of Circulation and Medical Imaging

  • Edmund Søvik, md phd · St Olavs Hospital, Dept of Radiology and Nuclear Medicine

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2023-05-01
Completion
2023-05-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04298112 on ClinicalTrials.gov