Summary

for males ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion
Thomas Hope

Description

Summary

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.

Official Title

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

Keywords

Prostate Cancer Recurrence Edetic Acid Ga-68 labeled PSMA-11 PET

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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.

You CAN'T join if...

  • 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).

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Thomas Hope
ID
NCT03353740
Phase
Phase 3
Study Type
Interventional
Last Updated