68GA-PSMA Fusion PET / MRI in Diagnosing Patients with Prostate Cancer

Status: Active

Description

This phase II trial studies how well 68GA-PSMA fusion PET / MRI works in finding prostate lesions in patients with prostate cancer. Radioactive drugs, such as 68GA-PSMA, are taken up by cancer cells. Diagnostic procedures, such as PET or MRI, may help find and diagnose prostate cancer or find out how far the disease has spread. Giving 68GA-PSMA fusion PET / MRI may work better in diagnosing patients with prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Prior mpMRI (within 3 months of recruitment) resulting in at least one Prostate Imaging Reporting and Data System (PI-RADS) 3-5 lesion with clinical need for a prostate biopsy procedure can participate, if one of the 2 criteria apply: * Known Gleason 3+3 or 3+4 prostate cancer undergoing active surveillance or in the confirmation phase of active surveillance, or * Rising prostate-specific antigen (PSA) and single or multiple negative prior biopsies.
  • Subjects who received a 68Ga-PSMA PET/CT and subsequent (clinical) TRUS-guided targeted biopsy, and are again in clinical need of a prostate biopsy can again take part in the study to receive a second 68Ga-PSMA PET/CT scan, however not earlier than 12 months after the prior 68Ga-PSMA PET/CT scan.

Exclusion Criteria

  • Prostate biopsy within 12 weeks prior to enrollment.
  • Acute prostatitis within the last 6 months.
  • Current non-urologic bacterial infection requiring active treatment with antibiotics.
  • Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years.
  • Body weight greater than 350 lbs (158 Kg).
  • Inability or unwillingness to receive a prostate biopsy procedure.
  • Unable to lie flat, still, or tolerate a PET/CT scan.
  • Unable to provide own consent.
  • Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).
  • Prisoner.

Locations & Contacts

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Morand Ruediger Piert
Phone: 734-936-5388

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Determine the sensitivity and specificity of multiparametric magnetic resonance imaging (mpMRI) alone and mpMRI in combination with gallium Ga 68-labeled PSMA-11 (68Ga-PSMA) positron emission tomography (PET) (i.e., fusion PET/MRI) for the detection of primary Gleason >= 3+4 primary prostate cancer (PCa).

SECONDARY OBJECTIVES:

I. Determine the safety of 68Ga-PSMA.

II. Determine frequency and location of 68Ga-PSMA positive lesions, such as potential extra-prostatic extension, lympho-nodal and/or distant metastatic disease positive on 68Ga-PSMA but not identified by conventional (standard) imaging.

EXPLORATORY OBJECTIVES:

I. Evaluate whether radiomics classifiers (obtained from mpMRI and 68Ga-PSMA identified targets) could improve identification and risk stratification of significant PCa.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) and 50-100 minutes later undergo PET over 15-40 minutes.

After completion of diagnostic testing, patients are followed up at 1-3 days.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Diagnostic

Lead Organization

Lead Organization
University of Michigan Comprehensive Cancer Center

Principal Investigator
Morand Ruediger Piert

Trial IDs

Primary ID UMCC 2018.072
Secondary IDs NCI-2018-02092, HUM00146602
Clinicaltrials.gov ID NCT03689582