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

Mayo Clinic

Status and phase: Completed; Early Phase 1

Conditions: Prostate Cancer

Treatments: Drug: Ga-68 PSMA11; Drug: F-18 PSMA 1007

Study type: Interventional

Funder types: Other

Identifiers

NCT03768349

NCI-2019-07001 (Registry Identifier)

18-006159

MC1952 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

PET/CT Ga-68 PSMA

Experimental group

Description:

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

Treatment:

Drug: Ga-68 PSMA11

PET/CT F-18 Labeled PSMA 1007

Experimental group

Description:

F-18 Labeled PSMA 1007 PET/CT

Treatment:

Drug: F-18 PSMA 1007