Gallium Ga 68-labeled PSMA-11 PET / CT in Diagnosing Participants with Biochemical 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) / computed tomography (CT) works in diagnosing patients with prostate cancer and with rising prostate specific antigen after treatment. Ga-68 PSMA is an imaging drug that binds to prostate tumor cells and can be imaged using PET. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET / CT, may help find the presence of prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Histopathological proven prostate adenocarcinoma
  • Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy) * Post radical prostatectomy (RP) – American Urological Association (AUA) recommendation ** PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and, ** Confirmatory persistent PSA greater than 0.2 ng/mL * Post-radiation therapy –American Society for Therapeutic Radiology and Oncology (ASTRO) (ASTRO)-Phoenix consensus definition ** Nadir + greater than or equal to 2 ng/mL rise in PSA
  • Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
  • Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria

  • Current investigational therapy for prostate cancer
  • Unable to lie flat, still or tolerate a PET scan
  • Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
  • 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 positive predictive value (PPV) of gallium Ga 68-labeled PSMA-11 (68Ga PSMA-11) PET/CT for detecting prostate cancer on a per-patient basis, confirmed by histopathology.

SECONDARY OBJECTIVES:

I. Determine sensitivity and PPV on a per-patient and per-region-basis of 68Ga-PSMA-11 PET/CT for detection of tumor location confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available.

II. Determine detection rates on a per-subject basis of 68Ga PSMA-11 PET/CT stratified by prostate-specific antigen (PSA) value (0.2 - <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - < 5.0, 5.0 or greater).

III. Determine the impact of 68Ga PSMA-11 PET/CT on clinical management in patients who have prostate cancer with biochemical recurrence.

IV. Continue to evaluate safety of 68Ga-PSMA-11.

OUTLINE:

Participants receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Within 50-100 minutes, participants undergo PET/CT over 30-40 minutes.

After completion of study treatment, participants are followed up for 1 day and then up to 12 months.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Diagnostic

Lead Organization

Lead Organization
University of Michigan Comprehensive Cancer Center

Principal Investigator
Morand Piert

Trial IDs

Primary ID UMCC 2017.016
Secondary IDs NCI-2018-00297
Clinicaltrials.gov ID NCT03396874