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

Early Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Ga-68 PSMA11; Drug: F-18 PSMA 1007

• Registration Number: NCT03768349
• Lead Sponsor: 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) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-07
• Study Start: 2019-01-03
• Primary Completion: 2021-07-21
• Study Completion: 2021-07-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PET/CT Ga-68 PSMA	Ga-68 PSMA11	Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT
PET/CT F-18 Labeled PSMA 1007	F-18 PSMA 1007	F-18 Labeled PSMA 1007 PET/CT

Primary Outcome Measures

Name	Time	Method
Tumor Detection on PET/CT	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 Outcome Measures

Name	Time	Method
Incidence of adverse events attributable to PSMA	12 Months	Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Impact of PSMA and C-11 choline PET on clinical management	12 Months	Descriptive statistics will be used to evaluate the impact of PSMA and C-11 choline PET on clinical management

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States