Clinical trial NCT05547386: 68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer
Official title: 68Ga-PSMA-11 PET/CT for Screening Prior to 177Lu-PSMA-617 Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Castration-Resistant Prostate Carcinoma
Metastatic Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 163
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of gallium Ga 68 gozetotide (68Ga-prostate-specific membrane antigen [PSMA)]-11)
timeFrame: After imaging scan is complete - up to 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Geoffrey B. Johnson, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: