A Study Using Gallium-68 PSMA-11 and C-11 Choline PET Imaging to Detect Metastatic Prostate Cancer in Patients

Overview

About this study

The purpose of this study is to examine PSMA and C-11 Choline PET in patients with suspected metastatic prostate cancer who have been imaged with 11C-Choline PET clinically and with PSMA PET (either Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 PSMA 1007) in order to demonstrate their utility in detecting prostate cancer.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Histopathological proven prostate adenocarcinoma.
  • Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam and/or brachytherapy) or prostate cancer ablation.
  • Post radical prostatectomy (RP) – with or without radiation.
  • PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
  • > 3 months post-surgery.
  • Post-radiation therapy –ASTRO-Phoenix consensus definition.
  • May or may not be castrate resistant (list prior therapies; i.e. androgen deprivation therapies).
  • Post-prostate cancer tissue ablation.
  • In patients post-ablation for primary prostate cancer treatment, PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after ablation.
  • > 3 months post-prostate bed ablation.
  • In patients with intact prostate, per ASTRO-Phoenix consensus definition.
  • Karnofsky performance status of 50 (or ECOG/WHO equivalent).
  • CT as part of the PET study or performed within 30 days of PSMA PET.
  • Age > 18 years old.
  • Ability to understand a written informed consent document, and the willingness to sign it.
  • Total testosterone test measured within 30 days of PSMA PET.

Exclusion Criteria:

  • Undergoing (or within 4 months) investigational therapy for prostate cancer.
  • Other ongoing (or within 4 months) treatments for prostate cancer including radiation therapy or chemotherapy.
  • 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.
  • 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.
  • Absence of PSA and total testosterone tests within 30 days.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Val Lowe, M.D.

Closed for enrollment

Contact information:

Jessica Brunn

(507)422-6025

Brunn.Jessica@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20449461

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