Registry to Evaluate Long-Term Outcomes in Patients Who Undergo 68-Ga-PSMA-11 PET/CT Imaging Evaluations
Stopped early
Conditions studied: Prostate Cancer (Adenocarcinoma)
In brief
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.
Key facts
- Study ID
- NCT06655064
- Run by
- Telix Pharmaceuticals (Innovations) Pty Limited
- People needed
- 120
- Starts
- 2025-01-30
- Expected to finish
- 2025-06-17
- Last updated by the study team
- 2025-07-14
Who can join
Age: 21 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Valley Urology — Fresno, California, United States
- Urology Associates of Central California — Fresno, California, United States
- Urological Associates of Western Colorado — Grand Junction, Colorado, United States
- Idaho Urologic Institute — Meridian, Idaho, United States
- Comprehensive Urology — Royal Oak, Michigan, United States
- Urology Nevada — Reno, Nevada, United States
- Oregon Urologic Institute — Springfield, Oregon, United States
- Jackson Urological Associates — Jackson, Tennessee, United States
- Urology San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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