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

Status: Active

Description

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. 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.

Eligibility 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
  • 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

Locations & Contacts

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
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
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Heiko Schoder
Phone: 212-639-7788

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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 undergo PET/MR or PET/computed tomography (CT).

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

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Diagnostic

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Heiko Schoder

Trial IDs

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