PSMA PET Imaging of Recurrent Prostate Cancer

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to see if a new diagnostic research agent named 68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid

Criteria

Inclusion Criteria:

• Biopsy proven adenocarcinoma of the prostate

• Initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible)

• For patients initially treated with surgery, radiation therapy, brachytherapy, or cryotherapy:

• PSA ≥ 0.2 ng/mL in at least two consecutive tests within 6 months of date of consent for patients

• Note: The most recent PSA value must be within 6 weeks of consent

• For patients who have received additional treatment in the recurrent or metastatic setting:

° PSA ≥ 2 ng/ml above the most recent therapy nadir

• Age ≥ 18 years

• Patient must be able to tolerate PET/CT or PET/MR imaging

Exclusion Criteria:

• Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.