Prostatic Neoplasms Clinical Trial
Official title:
Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients
NCT number | NCT04790968 |
Other study ID # | REK 50719 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 28, 2021 |
Est. completion date | June 2024 |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen | |
Norway | University Hosptial of North Norway | Tromsø | |
Norway | St Olavs Hospital, Trondheim University Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI | 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 | Sensitivity and specificity of PSMA PET/MRI | 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 | |
Secondary | Performance of PSMA PET/MRI versus PET/CT | Compare the performance of PET/MRI to PET/CT for detection of lymph node metastases | 1 month |
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