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Gallium Ga 68-labeled PSMA-11 PET / MR in Diagnosing Patients with Recurrent Prostate Cancer

Trial Status: Active

This phase II trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET) / magnetic resonance (MR) works in diagnosing patients with prostate cancer that has come back (recurrent). Gallium Ga 68-labeled PSMA-11 may help to show prostate cancer on a PET / MR scan that cannot be seen on other standard imaging even when the PSA levels are very low. It may also help doctors to make decisions about the care.

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 >= 0.2 ng/ml above the most recent therapy nadir
  • 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

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: ACTIVE
Contact: Heiko Schoder
Phone: 212-639-7788
Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Heiko Schoder
Phone: 212-639-7788
Montvale
Memorial Sloan Kettering Bergen
Status: ACTIVE
Contact: Heiko Schoder
Phone: 212-639-7788

New York

Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Heiko Schoder
Phone: 212-639-7788
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Heiko Schoder
Phone: 212-639-7788
Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Heiko Schoder
Phone: 212-639-7788
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Heiko Schoder
Phone: 212-639-7788

PRIMARY OBJECTIVE:

I. To provide clinical access to gallium Ga 68-labeled PSMA-11 (68Ga-HBED-iPSMA) PET at Memorial Sloan Kettering Cancer Center.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) and after 60-90 minutes, undergo PET/MR or PET/computed tomography (CT) over 30-45 minutes.

After completion of study, patients are followed up every 3-4 months for at least 2 years.

Trial Phase Phase II

Trial Type Diagnostic

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Heiko Schoder

  • Primary ID 16-306
  • Secondary IDs NCI-2017-01348
  • Clinicaltrials.gov ID NCT03204123