Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan
Recruiting · NCT06099093 · Interventional (participants receive a specific treatment) · Lead sponsor: Brigham and Women's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this research study is to see how well an imaging test, called 18FDCFPyL prostate specific membrane antigen (PSMA) positron emission tomography (PET), can show the extent of prostate cancer when comparing to 68Ga-PSMA-11 PET/CT (another type of diagnostic scan for prostate cancer).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participants must have histologically or cytologically confirmed prostate cancer.
- Age ≥18 years.
- Participants must be planned for standard-of-care 177Lu-Vipivotide Tetraxetan therapy after the 18F-DCFPyL PSMA-PET.
- ≥1 PSMA-avid lesion on 68Ga-PSMA-11 PSMA-PET performed within 120 days of study entry (to meet eligibility for 177Lu-Vipivotide Tetraxetan therapy).
- Ability and willingness to comply with the study procedures.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent are eligible for this trial.
- The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason and because radiopharmaceutical agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 24 hours after the 18F-DCFPyL PSMA-PET scan.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Contraindications to PET/CT, including severe claustrophobia.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL
- Any past or current condition that, in the opinion of the study investigators, would confound the results of the study or would pose additional risk or burden to the patient by their participation in the study.
Where it is running
2 locations listed across 1 US state.
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Brigham and Womens Hospital - Boston, Massachusetts, United States