Clinical trial NCT03768349: PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
Official title: PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Keywords: Prostate Cancer
PET/CT
PSMA
C-11 Choline
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tumor Detection on PET/CT
timeFrame: 12 Months post PET/CT
Secondary outcomes:
measure: Impact of PSMA and C-11 choline PET on clinical management
timeFrame: 12 Months
measure: Incidence of adverse events attributable to PSMA
timeFrame: 12 Months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Val Lowe, M.D.
role: PRINCIPAL_INVESTIGATOR
References: