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Gallium-68 PSMA-11 and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03768349
Recruitment Status : Active, not recruiting
First Posted : December 7, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Val Lowe, Mayo Clinic

Brief Summary:
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) in order to demonstrate their utility in detecting prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Ga-68 PSMA11 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Gallium-68 PSMA-11 and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  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 Ga68-PSMA11 and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.


Secondary Outcome Measures :
  1. Impact of Ga68-PSMA11 and C-11 choline PET on clinical management [ Time Frame: 12 Months ]
    Descriptive statistics will be used to evaluate the impact of Ga68-PSMA11 and C-11 choline PET on clinical management

  2. Incidence of adverse events attributable to Ga68-PSMA11 [ Time Frame: 12 Months ]
    Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768349


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Val Lowe, M.D. Mayo Clinic

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Responsible Party: Val Lowe, Prinicpal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03768349     History of Changes
Other Study ID Numbers: 18-006159
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After completion of the trial and IPD will be available for 2 years.
Access Criteria: Researchers collating data from multiple sites for submission to the FDA will be provided access to the IPD.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Val Lowe, Mayo Clinic:
Prostate Cancer
PET/CT
PSMA
C-11 Choline

Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents