Gallium Ga 68-labeled PSMA-11 PET / CT in Detecting Recurrent Prostate Cancer in Patients after Initial Therapy

Status: Active

Description

This clinical trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET) / computed tomography (CT) works in detecting prostate cancer that has come back in patients after initial therapy. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET / CT, may help doctors detect tumors that have come back after initial therapy.

Eligibility Criteria

Inclusion Criteria

  • Histopathological proven prostate adenocarcinoma
  • Rising PSA after definitive therapy with prostatectomy or radiation therapy. * Post radical prostatectomy (RP) ** PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP * Post-radiation therapy – American Society for Therapeutic Radiation and Oncology (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

  • Concomitant investigational therapy
  • Unable to lie flat, still or tolerate a PET scan
  • Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Johannes Czernin
Phone: 310-206-3226

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To evaluate gallium Ga 68-labeled PSMA-11 PET whole body imaging for detection of disease recurrence in clinically relevant anatomic regions.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.

After completion of study, patients are followed up for 3-12 months.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Diagnostic

Lead Organization

Lead Organization
UCLA / Jonsson Comprehensive Cancer Center

Principal Investigator
Johannes Czernin

Trial IDs

Primary ID 16-001095
Secondary IDs NCI-2016-01212
Clinicaltrials.gov ID NCT02940262