Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan
A Pilot Study of 18F-DCFPyL-PSMA PET in Patients Receiving 177Lu-Vipivotide Tetraxetan Therapy for Metastatic Castrate-resistant Prostate Cancer
About This Trial
- This study is testing how well a specialized body scan shows the spread of prostate cancer compared to another common imaging test.
- It is designed for adults with prostate cancer who are already scheduled to receive a specific type of targeted radiation treatment.
- To join, you must have had a recent scan showing cancer spread and be free of serious, uncontrolled health issues like severe heart problems.
- Before participating, you should know that you will undergo an extra imaging scan and will need to use birth control for a short time around the test.
More Information
- 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 Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing how well a specialized body scan shows the spread of prostate cancer compared to another common imaging test.
Study Details
- Start Date: April 1, 2024
- Lead Sponsor: Brigham and Women's Hospital
Full Eligibility Criteria
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.
Treatments
- Drug: 18F-DCFPyl