NCT04790968Completed
Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients
Source: ClinicalTrials.gov · Last updated 15 Nov 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 5 Mar 2021
- Start date
- 28 Apr 2021
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Norwegian University of Science and Technology
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT04790968
What you commit to
- Study type: Interventional
- Participants enrolled: 90
- From 28 Apr 2021 to the primary completion date, 30 Sept 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of any other cancer the last 5 years excluding basal cell carcinoma
- 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.
Other
- 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)
Who the study is looking for
- High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND; ISUP Gleason grade group ≥ 4
- High-risk localized/locally advanced prostate cancer patients scheduled for radiation treatment of the prostate and pelvic lymph nodes; ISUP Gleason grade group ≥ 4
Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| University Hosptial of North Norway Coordinator of this site? Confirm its status | Tromsø | Norway | Unknown status |
| St. Olavs Hospital, Trondheim University Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.