Registry to Evaluate Long-Term Outcomes in Patients Who Undergo 68-Ga-PSMA-11 PET/CT Imaging Evaluations
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Registration Number
- NCT06655064
- Lead Sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Brief Summary
The purpose of this research registry is to understand the real-world use of Illuccix PET/CT in prostate cancer, and how results from this testing impact patient's treatment and prostate cancer journey over time. It will follow subjects and the diagnostic testing and therapy they receive for their prostate cancer.
This is an observational research registry. Subjects will not be administered any medical diagnostic testing or therapy that they would not have normally undergone outside of participation in the registry.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 500
Participants will qualify for inclusion into Cohort 1, 2, or 3 only if they meet all the following criteria.
- Be a biological male at birth who is ≥ 21 years of age at the time of informed consent.
- Have undergone a 68Ga-PSMA-11 (Illuccix or Gozellix) PET/CT imaging evaluation within 60 days before enrolling in the study. (Prior imaging with alternate radioactive imaging agents are allowed, but enrollment imaging must be with 68Ga-PSMA-11(Illuccix or Gozellix).
- Have histopathologically confirmed prostate adenocarcinoma.
- Have a life expectancy of ≥ 6 months as determined by the investigator.
- Participants intended for enrollment in Cohort 1: Patients who have been newly diagnosed with prostate cancer and have not received any prior treatment for prostate cancer and have undergone a 68Ga-PSMA-11 PET/CT imaging evaluation to evaluate potential spread of the disease.
- Participants intended for enrollment in Cohort 2: Patients who have received previous treatment for prostate cancer and have and have undergone 68Ga-PSMA-11 PET/CT imaging evaluation for suspected recurrence (demonstrated by elevated PSA levels). Participants intended for enrollment in Cohort 3: Patients who have metastatic prostate cancer and undergone a 68Ga-PSMA-11 PET/CT imaging evaluation for the initiation of RLT.
- Be willing and able to provide informed consent and comply with the protocol requirements.
Participants are excluded from the study if any of the following criteria apply. All participants must NOT:
- Have any medical condition or other circumstances that, in the opinion of the Investigator, compromises the safety of the participant, the ability of the participant to comply with protocol requirements, the ability of the participant to complete the study, or confound study outcomes by being unable to produce reliable data over the course of the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective 3 years To evaluate the practical use of Illuccix or Gozellix 68Ga PSMA-11 PET/CT imaging in the real-world, by analyzing the long-term results in prostate cancer patients (including those who are newly diagnosed, have a suspected recurrence or are being evaluated for RLT).
- Secondary Outcome Measures
Name Time Method Secondary Objective #1 3 years To understand the utilization of 68GaPSMA-11 PET/CT imaging evaluations for initial staging in patients characterized by low risk to favorable intermediate risk (Grade Group 1 and 2: Gleason score 6 and 7 (3+4) prostate cancer).
Secondary Objective #2 3 years To understand the utilization of 68Ga PSMA-11 PET/CT imaging evaluations for detection of early disease recurrence/small lesion size detection in patients with low PSA values (less than 0.2 ng/mL).
Secondary Objective #3 3 years To understand the demographic and clinical characteristics of patients at the time of 68Ga-PSMA-11 PET/CT imaging evaluations.
Secondary Objective #4 3 years To understand the utilization of 68Ga-PSMA-11 PET/CT imaging in initial evaluation vs repeat conventional imaging in treatment planning decisions for patients with new and recurrent disease.
Secondary Objective #5 3 years To evaluate the clinical impact of 68Ga-PSMA-11 PET/CT imaging evaluation in the staging process of patients being considered for radioligand therapy. This includes assessing the ability of these imaging modalities to identify metastatic lesions, guide treatment planning, and predict patient outcomes.
Secondary Objective #6 3 years To understand the differential use of 68Ga-PSMA-11 PET/CT imaging evaluation for prostate cancer between racial and ethnic groups.
Trial Locations
- Locations (6)
Valley Urology
🇺🇸Fresno, California, United States
Urology Associates of Central California
🇺🇸Fresno, California, United States
Idaho Urologic Institute
🇺🇸Meridian, Idaho, United States
Comprehensive Urology
🇺🇸Royal Oak, Michigan, United States
Oregon Urologic Institute
🇺🇸Springfield, Oregon, United States
Urology San Antonio
🇺🇸San Antonio, Texas, United States