Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Oct 19, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how well a special imaging test called 18F-DCFPyL PSMA PET can show the spread of prostate cancer in patients who have metastatic castration-resistant prostate cancer (mCRPC). The researchers want to compare this new test with another existing scan called 68Ga-PSMA-11 PET/CT to see which one is better at detecting cancer. The trial is currently looking for male participants aged 18 and older who have been diagnosed with prostate cancer and are scheduled to receive a specific treatment called 177Lu-Vipivotide Tetraxetan after undergoing the 18F-DCFPyL PSMA PET scan.

To be eligible for the trial, participants must have confirmed prostate cancer and at least one area in their body where cancer is present, as shown by a recent scan. They need to be able to follow the study procedures and sign a consent form agreeing to participate. Participants should expect to have the PET scan and then continue with the planned treatment. It’s also important to know that due to the nature of the imaging tests, participants must agree to use effective birth control methods. Overall, this trial aims to improve how we detect and treat prostate cancer, potentially leading to better outcomes for patients.

Gender

MALE

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.