Registry to Evaluate Long-Term Outcomes in Patients Who Undergo 68-Ga-PSMA-11 PET/CT Imaging Evaluations
Reason given: Sponsor request
Key facts
- Where
- Fresno, Grand Junction, Jackson, Meridian, Reno, Royal Oak, San Antonio, and Springfield, United StatesSee the 9 sites
Where in United States
- Urology Associates of Central CaliforniaFresno, United StatesNo longer taking part
- Valley UrologyFresno, United StatesNo longer taking part
- Urological Associates of Western ColoradoGrand Junction, United StatesNo longer taking part
- Jackson Urological AssociatesJackson, United StatesNo longer taking part
- Idaho Urologic InstituteMeridian, United StatesNo longer taking part
- Urology NevadaReno, United StatesNo longer taking part
- Comprehensive UrologyRoyal Oak, United StatesNo longer taking part
- Urology San AntonioSan Antonio, United StatesNo longer taking part
- Oregon Urologic InstituteSpringfield, United StatesNo longer taking part
Trial details
- Who runs it
- Telix Pharmaceuticals (Innovations) Pty Limited
- Trial code
- NCT06655064
- Record updated
- 14 July 2025
- Original description
The purpose of this observational 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.Read full original descriptionShow less
Prospective Observational Multicenter Registry Study to Assess the Impact & Long-Term Outcomes of 68Ga-PSMA-11 PET/CT Imaging Evaluations for Patients With Prostate Cancer (Newly Diagnosed, Suspected Recurrence P or Are Candidates for Radioligand Therapy)
The purpose of this observational 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.
Subjects will not be administered any medical diagnostic testing or therapy that they would not have normally undergone outside of participation in the registry.
Inclusion: 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.
Exclusion: 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; Participants are excluded from the study if any of the following criteria apply. All participants must NOT:.