Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

University of California, San Francisco385 enrolled

Overview

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

385

Conditions

Prostate Cancer

Interventions

Ga-68 labeled PSMA-11 PETDRUG

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histopathological proven prostate adenocarcinoma. * Rising prostate-specific antigen (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 -ASTRO-Phoenix consensus definition * Nadir + greater than or equal to 2 ng/mL rise in PSA * Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent). * Age \> 18. * Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: * 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. * Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation

PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.

Time frame: 1 month

Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation

PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.

Time frame: 1 month

Secondary Outcomes

PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up

PPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.

Time frame: 1 month

PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up

PPVs on a per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.

Time frame: 1 month

Sensitivity on a Per-patient Basis

Sensitivity, on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.

Time frame: 1 month

Data from ClinicalTrials.gov

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