Clinical trial NCT02488070: 68Ga-PSMA PET/CT or PET/MRI in Evaluating Patients With Recurrent Prostate Cancer
Official title: 68Ga-PSMA PET/CT or PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recurrent Prostate Carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-07-02
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys\[Ahx\]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying prostate cancer that may have returned after a period of improvement (biochemical recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer receptor, which can then be imaged by the PET/CT or PET/MRI scanner.

Detailed description: PRIMARY OBJECTIVES:

Evaluate the feasibility and biodistribution of 68Ga-PSMA.

OUTLINE:

Patients are injected with 5 mCi of Ga68 PSMA intravenously (IV) and then undergo PET/CT or PET/MRI approximately 45 to 60 minutes later.

After completion of study, patients are followed up at 24 hours and 1 week.

Eligibility criteria: Inclusion Criteria:

* Provides written informed consent
* Known diagnosis of prostate cancer
* Patient has suspected recurrence based on biochemical data (prostate specific antigen \[PSA\] \> 2 ng/mL)
* Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria:

* Unable to provide informed consent
* Inability to lie still for the entire imaging time
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Primary outcomes:
measure: Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
timeFrame: an estimated average of 1 hour
measure: Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
timeFrame: an estimated average of 1 hour
measure: Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio)
timeFrame: an estimated average of 1 hour
measure: Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio)
timeFrame: an estimated average of 1 hour
Secondary outcomes:
measure: Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan
timeFrame: an estimated average of 2 hours
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford Cancer Institute
name: Andrei Iagaru
role: PRINCIPAL_INVESTIGATOR
References:
citation: Afshar-Oromieh A, Malcher A, Eder M, Eisenhut M, Linhart HG, Hadaschik BA, Holland-Letz T, Giesel FL, Kratochwil C, Haufe S, Haberkorn U, Zechmann CM. PET imaging with a [68Ga]gallium-labelled PSMA ligand for the diagnosis of prostate cancer: biodistribution in humans and first evaluation of tumour lesions. Eur J Nucl Med Mol Imaging. 2013 Apr;40(4):486-95. doi: 10.1007/s00259-012-2298-2. Epub 2012 Nov 24.
citation: Minamimoto R, Hancock S, Schneider B, Chin FT, Jamali M, Loening A, Vasanawala S, Gambhir SS, Iagaru A. Pilot Comparison of (6)(8)Ga-RM2 PET and (6)(8)Ga-PSMA-11 PET in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2016 Apr;57(4):557-62. doi: 10.2967/jnumed.115.168393. Epub 2015 Dec 10.