PSMA PET Imaging of Recurrent Prostate Cancer

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? PET/CT
Status: Active, not recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic Test, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only)
Basking Ridge
Memoral Sloan Kettering Monmouth (Consent only)
Middletown
Memorial Sloan Kettering Bergen (Consent only )
Montvale
New York
Memorial Sloan Kettering Commack (Consent only)
Commack
Memoral Sloan Kettering Westchester (Consent only)
Harrison
Memorial Sloan Kettering Cancer Center
New York
Memorial Sloan Kettering Nassau (Consent only)
Uniondale
Time Frame
Start Date: June 26, 2017
Estimated Completion Date: June 2023
Participants
Target number of participants: 1171
Treatments
Active Comparator: Ga-HBED-iPSMA PET with CT or MRI
Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.
Active Comparator: Ga-HBED-iPSMA PET with MRI
Participants will have a PET scan with Ga-HBED-iPSMA and will be combined with MRI. If PET/MR imaging is not available, PET/CT imaging may be substituted. This arm will be closed to accrual and these patients will be analyzed separately.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov