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68Ga-PSMA-11 PET in Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05197257
Recruitment Status : Recruiting
First Posted : January 19, 2022
Last Update Posted : April 7, 2022
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Adenocarcinoma Drug: Ga-PSMA-11 Phase 3

Detailed Description:

This is a prospective, Phase III, single-center, open-label to provide extended access in patients with biochemically recurrent prostate cancer. Approximately 100 patients are planned for enrollment in this study. Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

The intervention is a PET scan with the radiolabelled Prostate-specific membrane antifen (PSMA) ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.

AEs will be collected during injection and uptake phase (45-120 min posts infusion) of Ga-68 PSMA-11 PET/CT scan. All safety events will be recorded up to 120 min post injection.

Men with pathologically proven prostate adenocarcinoma, high risk cancer at diagnosis, evidence of biochemical recurrence, or known metastatic disease planned to start and change systemic therapy regimen.

One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with 100 MBq (3mCi)-300 MBq( 7mCi) of 68Ga-PSMA-11 via this catheter.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-PSMA-11 PET in Patients With Prostate Cancer
Actual Study Start Date : April 5, 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Men with pathologically proven prostate adenocarcinoma
The intervention is a PET scan with the radiolabelled PSMA ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.
Drug: Ga-PSMA-11
The PSMA Sterile Cold Kit, is a kit comprising all needed materials (lyophilized PSMA for PSMA reconstitution, elution vial for Ga and ancillary materials for transfer between vials) to perform a room-temperature radiolabelling of PSMA-11 with Ga. Ga is not part of the kit and should be provided in the form gallium chloride solution following the requirements of the relevant local regulations. PSMA-11 radiolabelled with Ga is administered in patients with prostate cancer recurrence after radical treatment.




Primary Outcome Measures :
  1. Grade and record incidence of Adverse Events (AEs) to measure safety of Ga-PSMA-11 [ Time Frame: 4 years ]
    Adverse Events (AEs) will be collected and reviewed to monitor for safety. Incidence and severity of AEs and adverse events will be estimated with 95% confidence intervals summarized with descriptive statistics. CTCAE version 5.0 will be used to grade AEs.

  2. Grade and record incidence of Adverse Events (AEs) to measure tolerability of Ga-PSMA-11 [ Time Frame: 4 years ]
    Adverse Events (AEs) will be collected and reviewed. Incidence and severity of AEs and adverse events will be estimated with 95% confidence intervals summarized with descriptive statistics. CTCAE version 5.0 will be used to grade AEs.


Secondary Outcome Measures :
  1. Determine the frequency of positive PSMA PET scans in relation to the PSA value before the PSMA scans [ Time Frame: 4 years ]
    Results will be summarized descriptively with 95% confidence intervals. Determine rate of major and minor changes in management by comparing planned management strategy using conventional imaging and executed management strategy incorporating information from 68Ga-PSMA-11 PET/CT, regardless of treatment modality.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically proven prostate adenocarcinoma
  • Age ≥ 18 years
  • Patients already diagnosed with prostate cancer: Primary Staging: intermediate and high-risk patients per NCCN guidelines
  • Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy):

    a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equal to 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a second determination of a PSA level of >0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenix consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA

  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

  • Unable to lie flat, still or tolerate a PET/CT scan, or any other condition that would preclude PET/CT imaging.
  • Patients with any medical condition or circumstance that the investigator believes may compromise the data collection or lead to a failure to fulfil the study requirements.
  • Patients with known hypersensitivity to the active substance or to any of the excipients of the investigational product.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05197257


Contacts
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Contact: Aaron Mobley 13037245693 aaron.mobley@cuanschutz.edu

Locations
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United States, Colorado
Colorado Research Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Aaron Mobley    720-848-5523    aaron.mobley@cuanschutz.edu   
Sub-Investigator: Jennifer Kwak         
Sub-Investigator: Rustain Morgan         
UCHealth-Metro Denver Recruiting
Denver, Colorado, United States, 80217-3364
Contact: Aaron Mobley    720-848-5523    aaron.mobley@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Bennett Chin Colorado Research Center
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT05197257    
Other Study ID Numbers: 21-4070.cc
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Newly Diagnosed
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Gallium 68 PSMA-11
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action