Status:
COMPLETED
Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
St. Olavs Hospital
Haukeland University Hospital
Conditions:
Prostatic Neoplasms
Neoplasm Metastasis
Eligibility:
MALE
Phase:
NA
Brief Summary
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 involv...
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 rela...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04790968
Start Date
April 28 2021
End Date
September 30 2024
Last Update
November 15 2024
Active Locations (3)
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1
Haukeland University Hospital
Bergen, Norway
2
University Hosptial of North Norway
Tromsø, Norway
3
St Olavs Hospital, Trondheim University Hospital
Trondheim, Norway