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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03768349
• Other study ID #: 18-006159
• Secondary ID: 18-006159NCI-201
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: January 3, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT04144010

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 1, 2024
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

Drug:
• Ga-68 PSMA11
Ga-68 PSMA11 PET/CT for detection of tumor location
• F-18 PSMA 1007
F-18 PSMA 1007 PET/CT for detection of tumor location

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Mayo Clinic Clinical Trials