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Metastatic Prostate AdenocarcinomaPhase 1/2NCT04685811

Evaluation of PSMA Antagonist Produced by Two Different Methods

A Phase 1/2 study testing 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron in people with Metastatic Prostate Adenocarcinoma, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 100 years, men only
Conditions the study is for
Metastatic Prostate Adenocarcinoma
What is being tested?
68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
9 Dec 2020to 30 Jun 2021
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Cornell Medicine

    New York, New York, 10021

Other trials in United States

About this study

Official title: Evaluation of a 68Ga Small Molecule PSMA Antagonist Produced by Two Different Methods

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.

Read the 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.

Being tested
68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotronDrug

    Also called Prostate specific membrane antigen imaging (PSMA)

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

Study groups in NCT04685811
Study groupRoleWhat they receive
68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotronExperimentalPatients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers.
Receives: Drug: 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 study visits between 24 to 48 hours apart

  2. 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.

    Measured: 2 study visits between 24 to 48 hours apart

  3. 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).

    Measured: 2 study visits between 24 to 48 hours apart

Secondary outcomes (2)

  1. Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Max SUV -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 Max SUV -pathologic regions

    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).

    Measured: 2 study visits between 24 to 48 hours apart

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

    The biodistribution of 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator will be evaluated by measuring the radioactivity concentration in various organs of interest. Based on the SUVmean and SUVmax, the RC unit will be used to compare these scans.

    PSMA positivity was defined as having a SUV value above that of the reference blood pool, liver, and/or salivary glands when evaluating lesions as described using the PROMISE criteria15. Quantitative analysis reviewed the SUVmax and SUVmean of the parotid gland, liver, and aortic arch (blood pool), as well as the SUVmax and SUVmean of suspected metastatic lesions. The same ROIs were evaluated on both scans for each respective patients.

    Measured: 2 study visits between 24 to 48 hours apart

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2020
  2. Study start9 Dec 2020
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04685811
Sponsor's protocol ID
19-11021092
Other IDs
7R01CA207645-03
Status last verified
Aug 2022
First submitted
2 Dec 2020
Last updated
22 Sep 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron in people with Metastatic Prostate Adenocarcinoma, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Pathologic Lesions (time frame: 2 study visits between 24 to 48 hours apart). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04685811.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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