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

Mayo Clinic1 site in 1 country250 target enrollmentJanuary 3, 2019

ConditionsProstate Cancer

InterventionsGa-68 PSMA11 F-18 PSMA 1007

DrugsGa-68 PSMA11 F-18 PSMA 1007

Overview

Phase: Early Phase 1
Intervention: Ga-68 PSMA11
Conditions: Prostate Cancer
Sponsor: Mayo Clinic
Enrollment: 250
Locations: 1
Primary Endpoint: Tumor Detection on PET/CT
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.

Registry

clinicaltrials.gov

Start Date

January 3, 2019

End Date

July 21, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Val Lowe

Prinicpal Investigator

Mayo Clinic

Eligibility Criteria

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.
•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.

Arms & Interventions

PET/CT Ga-68 PSMA

Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT

Intervention: Ga-68 PSMA11

PET/CT F-18 Labeled PSMA 1007

F-18 Labeled PSMA 1007 PET/CT

Intervention: F-18 PSMA 1007

Outcomes

Primary Outcomes

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.