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

Primary Purpose

Prostate Cancer, Prostate Adenocarcinoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ga-PSMA-11
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Newly Diagnosed

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Colorado Research Center
  • UCHealth-Metro Denver

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Men with pathologically proven prostate adenocarcinoma

Arm Description

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.

Outcomes

Primary Outcome Measures

Grade and record incidence of Adverse Events (AEs) to measure safety of Ga-PSMA-11
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.
Grade and record incidence of Adverse Events (AEs) to measure tolerability of Ga-PSMA-11
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

Determine the frequency of positive PSMA PET scans in relation to the PSA value before the PSMA scans
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.

Full Information

First Posted
December 16, 2021
Last Updated
October 18, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05197257
Brief Title
68Ga-PSMA-11 PET in Patients With Prostate Cancer
Official Title
68Ga-PSMA-11 PET in Patients With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
April 14, 2022 (Actual)
Study Completion Date
April 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma
Keywords
Newly Diagnosed

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Men with pathologically proven prostate adenocarcinoma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ga-PSMA-11
Intervention Description
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 Measure Information:
Title
Grade and record incidence of Adverse Events (AEs) to measure safety of Ga-PSMA-11
Description
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.
Time Frame
4 years
Title
Grade and record incidence of Adverse Events (AEs) to measure tolerability of Ga-PSMA-11
Description
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.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Determine the frequency of positive PSMA PET scans in relation to the PSA value before the PSMA scans
Description
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.
Time Frame
4 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bennett Chin
Organizational Affiliation
Colorado Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado Research Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UCHealth-Metro Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80217-3364
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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