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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Ga-68 PSMA11; Drug: F-18 PSMA 1007

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Early Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)	12 Months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): July 21, 2021
• Study Completion (Estimated): December 1, 2024

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 (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PET/CT; Prostate Cancer; PSMA; C-11 Choline
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Recurrence; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: 18-006159 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2019-07001 (Registry Identifier: Clinical Trials Reporting Program (CTRP))

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