68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer

Mayo Clinic

Status and phase: Completed; Phase 3

Conditions: Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8

Treatments: Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Drug: Gallium Ga 68 Gozetotide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05547386

22-003732 (Other Identifier)

NCI-2022-04135 (Registry Identifier)

Details and patient eligibility

About

This phase III study provides access to 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) imaging for patients with castrate-resistant prostate cancer that has spread to other places in the body (metastatic) being considered for177Lu-PSMA-617 therapy. T PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of this tracer. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Combining a PET scan with a CT scan can help make the images easier to interpret. The 68Ga-PSMA-11 PET/CT scan is done with a very small amount of radioactive tracer call 68- gallium PSMA-11. In patients that have been diagnosed with prostate cancer, a protein called prostate-specific membrane antigen (PSMA) appears in large amounts on the surface of the cancerous cells. The radioactive imaging agent (68Ga-PSMA-11) has been designed to circulate through the body and attach itself to the PSMA protein on prostate cancer cells. A PET/CT scan is then used to detect the location of prostate cancer lesions. By gaining access to 68Ga-PSMA-11 PET/CT scans, patients may be safely screened for 177Lu-PSMA-617 therapy in the treatment of metastatic castrate resistant prostate cancer.

Full description

PRIMARY OBJECTIVE:

I. To overcome a clinical access issue that would otherwise block patients from reimbursement of a new cancer therapy, and therefore block or significantly delay their care.

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV) and then undergo a positron emission tomography (PET)/computed tomography (CT) scan throughout the trial.

Enrollment: 163 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• An adult male patient who is actively under the care of a medical oncology, radiation oncology or urology physician at Mayo Clinic

• An adult male patient who is deemed eligible (or potentially/likely eligible) for PSMA-targeted radionuclide therapy by a nuclear medicine physician or Radiologist in the nuclear medicine therapy practice, or by the Prostate Theranostic Tumor Board (PTuB)

  • Eligibility will be documented in the medical record by the clinical practice
  • It is acceptable for the patient to be eligible for PSMA-targeted radionuclide therapy in all regards except for having completed a PSMA-targeted PET scan showing PSMA-positive prostate cancer
  • It is acceptable for a patient to be potentially eligible for therapy, but have a relative contraindication, such as a minor laboratory abnormality, and be on the list for discussion at the PTuB in the future

• An adult male patient who has not received a 68Ga-PSMA-11 PET/CT or PET/magnetic resonance (MR), or for whom a repeat 68Ga-PSMA-11 PET/CT exam is needed per the clinical practice to ensure eligibility

• An adult male patient who does not otherwise have access to a reimbursable clinical 68Ga-PSMA-11 PET scan

• An adult above the ages of 18

Exclusion criteria

• A patient who is unable to consent per Mayo guidelines
• A patient who is unable to lay still, or otherwise successfully complete the imaging exam

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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163 participants in 1 patient group

Observational (68Ga-PSMA-11 PET/CT)

Experimental group

Description:

Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial.

Treatment:

Drug: Gallium Ga 68 Gozetotide

Procedure: Positron Emission Tomography

Procedure: Computed Tomography