NCT03392181Active, not recruitingEarly phase 1
PET/MRI for the Staging of Newly Diagnosed Prostate Cancer
Source: ClinicalTrials.gov · Last updated 23 May 2025
Brief summary (registry, in English)
The purpose of this study is to gain understanding of how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 2 Jan 2018
- Start date
- 8 Jun 2018
- Primary completion date
- 1 May 2026
- Lead sponsor
- Northwestern University
- Diseases
- Prostate cancer
- NCT number
- NCT03392181
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 48
- From 8 Jun 2018 to the primary completion date, 1 May 2026
- 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 who are claustrophobic will be required to take an anti-anxiety medication prescribed by their physician one hour prior to the scan
- Patients may not be receiving any other treatments or investigational agents
- Patients who have received androgen deprivation therapy or prior surgery for prostate cancer
Other illness
- Patients not interested in pursuing surgical intervention for their disease (i.e. refusing treatment or requesting radiation oncology referral)
Lab values
- Patients with a GFR \<30mL/min are ineligible to receive intravenous contrast per standard MR exclusion criteria
Other
- Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments)
- Patients who report taking multivitamins and/or folate supplements on the day of the scan
Who the study is looking for
- Patients must have a biopsy-proven diagnosis of high risk, very high risk, or locally advanced prostate cancer
- Patients must have a diagnosis of high risk, very high risk, or locally advanced prostate cancer per NCCN Guidelines (T3-T4 disease)
- Patients are healthy enough to be deemed surgical candidates with an ECOG performance status of 0-2
- Patients must be age ≥ 18 years
- Patients must agree to use adequate contraception (e.g. barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of the imaging
- Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
Age in the registry: 18 years to 89 years · 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 |
|---|---|---|---|
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.