Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence

Overview

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

Full Title of Study: “Gallium-68 PSMA-11 PET Imaging in Patients With Biochemical Recurrence”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2020

Interventions

  • Drug: Ga-68 labeled PSMA-11 PET
    • 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.

Arms, Groups and Cohorts

  • Experimental: Ga-68 labeled PSMA-11 PET
    • PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location in prostate bed confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
    • Time Frame: 1 day
    • Point estimate of the sensitivity will be calculated with the corresponding 95% confidence interval.
  • Sensitivity on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location in pelvis outside of prostate bed including lymph nodes confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
    • Time Frame: 1 Day
    • Point estimate of the sensitivity will be calculated with the corresponding 95% confidence interval.
  • Sensitivity on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location in extrapelvic soft tissue, lymph nodes and organ metastases (non-bone) confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
    • Time Frame: 1 Day
    • Point estimate of the sensitivity will be calculated with the corresponding 95% confidence interval.
  • Sensitivity on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location in bone metastases confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
    • Time Frame: 1 Day
    • Point estimate of the sensitivity will be calculated with the corresponding 95% confidence interval.

Secondary Measures

  • Positive predictive value (PPV) for detection of tumor location in prostate bed confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
    • Time Frame: 1 Day
    • Probability of a positive prediction calculated and reported with the corresponding two-sided 95% confidence intervals
  • PPV for detection of tumor location in pelvis outside of prostate bed including lymph nodes confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
    • Time Frame: 1 Day
    • Probability of a positive prediction calculated and reported with the corresponding two-sided 95% confidence intervals intervals
  • PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location in extrapelvic soft tissue, lymph nodes and organ metastases (non-bone) confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
    • Time Frame: 1 Day
    • Probability of a positive prediction calculated and reported with the corresponding two-sided 95% confidence intervals
  • PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location in bone metastases confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
    • Time Frame: 1 Day
    • Probability of a positive prediction calculated and reported with the corresponding two-sided 95% confidence intervals
  • Detection rates of 68Ga-PSMA-11 PET stratified by PSA value
    • Time Frame: 1 Day
    • Detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA value (0.2- <0.5, 0.5 – <1.0, 1.0 – <2.0, 2.0 – <5.0, >=5.0) will be summarized in tabular format and compared between PSA strata using chi-square analysis. Detection rate is defined as number of patients with PSMA positive disease, independent of pathology, imaging or clinical follow-up. A detection rate will be reported for each reader independently stratified by PSA.
  • Impact of 68Ga-PSMA-11 PET on clinical management in patients with biochemical recurrence (BCR)
    • Time Frame: Up to 6 months
    • Evaluated using descriptive statistics based on qualitative physician responses from the change in management surveys
  • Inter-reader reproducibility for positivity
    • Time Frame: 1 Day
    • Inter-reader reproducibility for positivity at the patient level and region level will be reported using the Fleiss’ Kappa test for multiple readers

Participating in This Clinical Trial

Inclusion Criteria

  • Histopathologically proven prostate adenocarcinoma.
  • Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
  • Post radical prostatectomy (RP) – American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy
  • PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
  • Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy
  • 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).
  • Age >= 18.
  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria

  • Unable to lie flat, still or tolerate a PET scan.
  • Concomitant investigational therapy.
  • 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.
  • 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).

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Thomas Hope
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Thomas Hope, Assistant Professor – University of California, San Francisco
  • Overall Official(s)
    • Thomas Hope, MD, Principal Investigator, University of California, San Francisco

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