Skip to main content
OpenTrials
Completed

NCT Number: NCT03768349

PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer

Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histopathological proven prostate adenocarcinoma.
  • Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. > 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies)

  • Karnofsky performance status of 50 (or ECOG/WHO equivalent).
  • CT or as part of the PET study or performed within one month of PSMA PET.
  • Age > 18.
  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

  • Undergoing investigational therapy for prostate cancer.
  • Other ongoing treatments for prostate cancer including radiation therapy, chemotherapy or androgen deprivation. Androgen deprivation within the last 4 months excluding finasteride, dutasteride or other 5 alpha reductase inhibitors (excluding castrate resistant subjects).
  • 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).
  • Absence of PSA and total testosterone tests within 4 weeks.

Treatment and study plan

Ga-68 PSMA11

Drug

Ga-68 PSMA11 PET/CT for detection of tumor location

F-18 PSMA 1007

Drug

F-18 PSMA 1007 PET/CT for detection of tumor location

Primary outcomes

  1. Tumor Detection on PET/CT

    Time frame: 12 Months post PET/CT

    Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.

Secondary outcomes

  1. Impact of PSMA and C-11 choline PET on clinical management

    Time frame: 12 Months

    Descriptive statistics will be used to evaluate the impact of PSMA and C-11 choline PET on clinical management

  2. Incidence of adverse events attributable to PSMA

    Time frame: 12 Months

    Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2018
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.