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

Phase 3

Completed

• Conditions: Prostate Adenocarcinoma; Prostate Cancer
• Interventions: Drug: Ga-PSMA-11

• Registration Number: NCT05197257
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2021-09-29
• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-19
• Primary Completion: 2022-04-14
• Study Completion: 2022-04-14
• Results First Submitted: 2023-08-23
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Results First Posted: 2023-11-13
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 39

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Men with pathologically proven prostate adenocarcinoma	Ga-PSMA-11	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	Immediately after administration and for 1 hour and 30 minutes afterwards	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.

Secondary Outcome Measures

Name	Time	Method
Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities.	2 hours	Determine the frequency of positive PSMA PET scans in relation to the PSA value before the PSMA scans and compared to conventional imaging. Results will be summarized descriptively with 95% confidence intervals. Determine rate of overall changes in management by comparing planned management strategy using conventional imaging with executed management strategy incorporating information from 68Ga-PSMA-11 PET/CT, regardless of treatment modality.; Analysis: The rate of change in management based on the incorporation of68Ga-PSMA-11 PET/CT results will be expressed as the percentage of total patients imaged in which change in management occurred, regardless of treatment modality. The rate of change in management will also be estimated within each group (initial staging, biochemical recurrence, and pre/post treatment). 95% confidence intervals (CIs) will be used to express precision of the estimates.

Trial Locations

Locations (2)

Colorado Research Center; 🇺🇸 Aurora, Colorado, United States

UCHealth-Metro Denver; 🇺🇸 Denver, Colorado, United States