Phase
Condition
Prostate Cancer
Urologic Cancer
Prostate Cancer, Early, Recurrent
Treatment
18F-DCFPyl
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have histologically or cytologically confirmed prostate cancer.
Age ≥18 years.
Participants must be planned for standard-of-care 177Lu-Vipivotide Tetraxetantherapy after the 18F-DCFPyL PSMA-PET.
-≥1 PSMA-avid lesion on 68Ga-PSMA-11 PSMA-PET performed within 120 days of studyentry (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 ortreatment does not have the potential to interfere with the safety or efficacyassessment of the investigational agent are eligible for this trial.
The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reasonand because radiopharmaceutical agents used in this trial are known to beteratogenic, women of child-bearing potential and men must agree to use adequatecontraception (hormonal or barrier method of birth control; abstinence) prior tostudy entry and for 24 hours after the 18F-DCFPyL PSMA-PET scan.
Ability to understand and the willingness to sign a written informed consentdocument.
Exclusion
Exclusion Criteria:
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, orcardiac arrhythmia.
Contraindications to PET/CT, including severe claustrophobia.
History of allergic reactions attributed to compounds of similar chemical orbiologic composition to 18F-DCFPyL
Any past or current condition that, in the opinion of the study investigators, wouldconfound the results of the study or would pose additional risk or burden to thepatient by their participation in the study.
Study Design
Study Description
Connect with a study center
Brigham and Womens Hospital
Boston, Massachusetts 02215
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United StatesActive - Recruiting
Brigham and Womens Hospital
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02115
United StatesActive - Recruiting

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