NCT04986280Completed
Diagnostic Accuracy and Performance of 18F-PSMA-1007
Diagnostic Accuracy and Performance of 18F-PSMA-1007 in the Detection of Recurrent Prostate Cancer - a Prospective, Single-arm Study
Source: ClinicalTrials.gov · Last updated 7 Jun 2024
Brief summary (registry, in English)
Whereas 18F-PSMA-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. The purpose of this study is to determine the diagnostic performance for this radiotracer.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 174 (actual)
- First submitted
- 12 Apr 2021
- Start date
- 13 Jul 2021
- Primary completion date
- 12 Sept 2022
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Prostate cancer
- NCT number
- NCT04986280
What you commit to
- Study type: Observational
- Participants enrolled: 174
- From 13 Jul 2021 to the primary completion date, 12 Sept 2022
- 1 site 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
- Patients with ADT within 6 months prior to the PSMA-PET/CT
Other illness
- Patients undergoing active treatment for a second non-prostatic malignancy
Other
- Inability to provide informed, written consent
Who the study is looking for
- Adult Patients referred for investigation of recurrent PC by PSMA PET/CT.
- Patients with known biochemical recurrence of a histologically confirmed primary prostate cancer, defined as:
- Post prostatectomy: two consecutive PSA \> 0.2 ng/ml Post-radiotherapy: a rise of 2ng/mL \> post-therapy nadir (ASTRO consensus definition)
- Male patients \>18 years old
- PSA measured ± 4 weeks of the PSMA-PET/CT
- Patients willing and able to consent to the informed consent document
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inselspital Universitätsspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.