Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT scan
Given IV
PROCEDUREPositron Emission Tomography
Undergo PET/CT scan
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients Reporting Adverse Reactions | From the time of injection until the time after imaging scan is complete, up to 1 day | Safety of gallium Ga 68 gozetotide \[68Ga-prostate-specific membrane antigen (PSMA)-11\] assessed by the number of patients reporting unexpected adverse reactions from the time of injection until the time they leave the care of the division of nuclear medicine. If any adverse reactions are reported, the patient will be evaluated by a nurse and/or physician and will receive appropriate care. The principal investigator (PI) or those designated by the PI will ascertain the severity of the adverse event and how likely the adverse reaction was associated with the injected 68Ga-PSMA-11. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observational (68Ga-PSMA-11 PET/CT) Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial.
Computed Tomography: Undergo PET/CT scan
Gallium Ga 68 Gozetotide: Given IV
Positron Emission Tomography: Undergo PET/CT scan | 163 |
| Total | 163 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Observational (68Ga-PSMA-11 PET/CT) | — |
|---|---|---|
| Age, Customized 30-39 | 1 Participants | — |
| Age, Customized 40-49 | 1 Participants | — |
| Age, Customized 50-59 | 9 Participants | — |
| Age, Customized 60-69 | 63 Participants | — |
| Age, Customized 70-79 | 69 Participants | — |
| Age, Customized 80-89 | 18 Participants | — |
| Age, Customized 90-99 | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 163 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 163 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 156 |
| other Total, other adverse events | 0 / 156 |
| serious Total, serious adverse events | 0 / 156 |
Outcome results
Primary
Patients Reporting Adverse Reactions
Safety of gallium Ga 68 gozetotide \[68Ga-prostate-specific membrane antigen (PSMA)-11\] assessed by the number of patients reporting unexpected adverse reactions from the time of injection until the time they leave the care of the division of nuclear medicine. If any adverse reactions are reported, the patient will be evaluated by a nurse and/or physician and will receive appropriate care. The principal investigator (PI) or those designated by the PI will ascertain the severity of the adverse event and how likely the adverse reaction was associated with the injected 68Ga-PSMA-11.
Time frame: From the time of injection until the time after imaging scan is complete, up to 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational (68Ga-PSMA-11 PET/CT) | Patients Reporting Adverse Reactions | 0 Participants |