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

April 3, 2025 updated by: Val Lowe, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histopathological proven prostate adenocarcinoma.

  2. 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)

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

Exclusion Criteria:

  1. Undergoing investigational therapy for prostate cancer.
  2. 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).
  3. Unable to lie flat, still or tolerate a PET scan.
  4. 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.
  5. 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).
  6. Absence of PSA and total testosterone tests within 4 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET/CT Ga-68 PSMA
Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT
Drug: Ga-68 PSMA11
Ga-68 PSMA11 PET/CT for detection of tumor location
Experimental: PET/CT F-18 Labeled PSMA 1007
F-18 Labeled PSMA 1007 PET/CT
Drug: F-18 PSMA 1007
F-18 PSMA 1007 PET/CT for detection of tumor location

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months post PET/CT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 Months
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)
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Val Lowe, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2019

Primary Completion (Actual)

July 21, 2021

Study Completion (Actual)

July 21, 2021

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-006159 (Other Identifier: Mayo Clinic Institutional Review Board)
  • NCI-2019-07001 (Registry Identifier: Clinical Trials Reporting Program (CTRP))
  • MC1952 (Other Identifier: Mayo Clinic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD data from this trial will be available to other researchers that will collate similar data from multiple sites to provide data to the FDA.

IPD Sharing Time Frame

After completion of the trial and IPD will be available for 2 years.

IPD Sharing Access Criteria

Researchers collating data from multiple sites for submission to the FDA will be provided access to the IPD.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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