Clinical trial NCT04685811: Evaluation of PSMA Antagonist Produced by Two Different Methods
Official title: Evaluation of a 68Ga Small Molecule PSMA Antagonist Produced by Two Different Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Prostate Adenocarcinoma
Keywords: Prostate Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2020-12-28
Enrollment: 16
Sex: MALE
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers. The goal of the study is to evaluate repeatability and equivalence across the different 68Ga-PSMA production methods. This research study is being conducted to assess whether the PET/CT imaging results, as generated from the two different 68Ga production methods, are equivalent.

Detailed description: Patients with metastatic prostate adenocarcinoma will be enrolled in the study and will undergo two 68Ga-Prostate Specific Membrane Antigen- Positron Emission Tomography (PSMA-PET) scans within 24-48 hours. The difference between the two scans is that the radiotracer used in each scan will be produced with a different method (68Ga-PSMA-cyclotron and 68Ga-PSMA-generator produced). The first scan will occur after a baseline clinical evaluation, which will include a history, physical, and baseline lab draw. After each scan, blood draws will be obtained.

The purpose of this study is to evaluate equivalence of two processes to create 68Ga-HBED-PSMA and compare dosimetry, biodistribution and whole body excretion/ metabolism. Furthermore, the research team will perform dynamic analysis of the PET scans to investigate repeatability of whole-body 68Ga-PSMA-generator Ki Patlak imaging against that of conventional whole-body 68Ga-PSMA- SUV imaging and evaluate equivalence of whole-body 68Ga-PSMA Ki Patlak imaging between the two processes to create 68Ga-HBED-PSMA (68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator). Patients will afterwards receive standard of care treatment and follow up imaging.

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following criteria to be enrolled in this study:

* Aged 21 years or older and below 80 years of age
* Signed written informed consent and willingness to comply with protocol requirements
* Histologically confirmed diagnosis of metastatic prostate cancer
* Staging imaging exam confirming metastatic disease, e.g. total body MRI, or CT chest/abdomen/pelvis, 99mTc bone scan, NaF PET

Exclusion Criteria:

* Laboratory values:
* Serum creatinine \>2.5 mg/dL
* AST (SGOT) \>2.5x ULN
* Bilirubin (total) \>1.5x ULN
* Serum calcium \>11 mg/dL
* Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject.
* Presence of serious systemic illness, including: uncontrolled inter-current infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might limit compliance with study requirements.
* Other severe acute or chronic medical condition(s) or laboratory abnormality(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and in the judgment of the investigator, would make the patient inappropriate for entry into this study.
* Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.

Primary outcomes:
measure: Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Pathologic Lesions
timeFrame: 2 study visits between 24 to 48 hours apart
measure: Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Average SUV Max-pathologic Regions
timeFrame: 2 study visits between 24 to 48 hours apart
measure: ICC Between Generator PSMA Scan vs Cyclotron PSMA Scan: Total Lesion Average SUVMax
timeFrame: 2 study visits between 24 to 48 hours apart
Secondary outcomes:
measure: Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Max SUV -Pathologic Regions
timeFrame: 2 study visits between 24 to 48 hours apart
measure: Compare Bio-Distribution Between 68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator
timeFrame: 2 study visits between 24 to 48 hours apart
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Joseph R Osborne, M.D.
role: PRINCIPAL_INVESTIGATOR
References: