Evaluation of PSMA Antagonist Produced by Two Different Methods

NCT04685811 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 19-110210927R01CA207645-03
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Prostate Adenocarcinoma

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Pathologic Lesions

  Single score Intraclass Correlation Coefficient (ICC) was calculated as an index for reliability between 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator across varying pathologic lesions. The ICC, based on a one-way random effects model was used to assess reliability. The ICC ratios in this data shows the top five lesions with the greatest PSMA uptake (SUV) in each patient. This is a measure of the variance of interest (for the patient's lesion) over the total variance (from all data points for that particular lesion of interest). Repeatability was evaluated by calculating the variance among group means of the SUVmean and SUVmax of each reference and lesion over the sum of the group-level and datalevel (residual) variance. The lesions reported in this analysis range from the SUV of reference organs to the average SUV of a metastatic deposit. These scans were also performed within 48 hours of each other to limit heterogeneity that may correspond to disease progression or PSMA avidity.

  2 study visits between 24 to 48 hours apart

• Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Average SUV Max-pathologic Regions

  Single score intraclass correlation coefficient (ICC) was calculated as an index for reliability between 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator across varying average SUV Max-pathologic regions The ICC ratios in this data provides a general performance review of uptake in both pathological lesions and reference lesions, specifically the average SUVmax of bone metastases, lymph nodes, salivary glands, and the spleen.

  2 study visits between 24 to 48 hours apart

• ICC Between Generator PSMA Scan vs Cyclotron PSMA Scan: Total Lesion Average SUVMax

  Repeatability was evaluated by calculating the variance among group means of the SUVmean and SUVmax of each reference and lesion over the sum of the group-level and datalevel (residual) variance. The intraclass correlation coefficient (ICC), based on a one-way random effects model (i.e., assumes subjects are randomly selected from the larger population), was used to assess reliability between generator and cyclotron scanning methods. BlandAltman analysis evaluated the agreement between the two scanning methods. Confidence levels of 95% were estimated to assess precision of the obtained estimates. All analyses were performed in R Version 4.0.5 (R Foundation for Statistical Computing, Vienna, Austria).

  2 study visits between 24 to 48 hours apart

Secondary Outcomes (2)

• Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Max SUV -Pathologic Regions

  2 study visits between 24 to 48 hours apart

• Compare Bio-Distribution Between 68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator

  2 study visits between 24 to 48 hours apart

Study Arms (1)

68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron

EXPERIMENTAL

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.

Drug: 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron

Interventions

68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron DRUG

68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron; single dose each, approximately 100-300 mBq.

Also known as: Prostate specific membrane antigen imaging (PSMA)

68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

The small sample size which resulted from recruitment and logistical challenges was a limiting factor in the analytical interpretation. It is important to note that the purpose of the study was to determine if the equivalency can also translate to mass production in the clinical setting. Future studies should evaluate the cost-benefit analysis of 68Ga based radioisotopes with 18F. We anticipate that production of 68GaPSMA cyclotron is a cost-efficient method of 68Ga production for clinical use.

Results Point of Contact

• Title: Dr. Juana Martinez Zuloaga
• Organization: Weill Cornell Medical College

jum4005@med.cornell.edu

212-746-6000

Study Officials

• Joseph R Osborne, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 28, 2020
• Study Start: December 9, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 22, 2022
• Results First Posted: September 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)