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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 3

Conditions: Prostate Adenocarcinoma; Prostate Cancer

Treatments: Drug: Ga-PSMA-11

Study type: Interventional

Funder types: Other

Identifiers

NCT05197257

21-4070.cc

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Men with pathologically proven prostate adenocarcinoma

Experimental group

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.

Treatment:

Drug: Ga-PSMA-11