Registry to evaluate long-term outcomes in prostate cancer patients using PET/CT imaging
A Prospective Observational Multicenter Registry Study to Assess the Impact and Long-Term Outcomes of 68Ga-PSMA-11 PET/CT Imaging Evaluations for Patients With Newly Diagnosed, or Suspected Recurrent Prostate Cancer or Are Candidates for Radioligand Therapy for Prostate Cancer
This study looks at how using a special type of imaging called PET/CT can help doctors make better treatment decisions for men with prostate cancer over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 21 Years and up |
| Sex | Male |
| Sponsor | Telix Pharmaceuticals (Innovations) Pty Limited Industry-sponsored |
| Locations | 6 sites (Fresno, California and 5 other locations) |
| Trial ID | NCT06655064 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to understand the real-world application of 68Ga-PSMA-11 PET/CT imaging in patients with prostate cancer. It will track the diagnostic testing and treatments these patients receive over time, focusing on how imaging results influence their treatment journey. Participants will not receive any additional medical interventions outside of their standard care. The study will include various cohorts based on the patients' treatment history and diagnosis.
Who should consider this trial
Good fit: Ideal candidates are biological males aged 21 and older with histopathologically confirmed prostate adenocarcinoma who have undergone a 68Ga-PSMA-11 PET/CT imaging evaluation within the last 60 days.
Not a fit: Patients who do not have prostate adenocarcinoma or have not undergone the specified imaging evaluation will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness of PET/CT imaging in guiding treatment decisions for prostate cancer patients.
How similar studies have performed: While this approach is observational, similar studies have shown that real-world data can significantly enhance understanding of treatment outcomes in prostate cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants will qualify for inclusion into Cohort 1, 2, or 3 only if they meet all the following criteria. 1. Be a biological male at birth who is ≥ 21 years of age at the time of informed consent. 2. 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). 3. Have histopathologically confirmed prostate adenocarcinoma. 4. Have a life expectancy of ≥ 6 months as determined by the investigator. 5. 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. 6. 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. 7. Be willing and able to provide informed consent and comply with the protocol requirements. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply. All participants must NOT: 1. 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 this trial is running
Fresno, California and 5 other locations
- Valley Urology — Fresno, California, United States (Recruiting)
- Urology Associates of Central California — Fresno, California, United States (Recruiting)
- Idaho Urologic Institute — Meridian, Idaho, United States (Recruiting)
- Comprehensive Urology — Royal Oak, Michigan, United States (Recruiting)
- Oregon Urologic Institute — Springfield, Oregon, United States (Recruiting)
- Urology San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Lorraine ODonnell, MS, MBA, CCRC
- Email: lorraine.odonnell@cardinalhealth.com
- Phone: 914-388-4907
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.