68ga-psma-11 pet/ct screening prior to 177lu-psma-617 therapy for patients with metastatic castrate resistant prostate cancer

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

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.

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