Registry to Evaluate Long-Term Outcomes in Patients Who Undergo 68-Ga-PSMA-11 PET/CT Imaging Evaluations

Terminated

• Conditions: Prostate Cancer (Adenocarcinoma)

• Registration Number: NCT06655064
• Lead Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-23
• Study Start: 2025-01-30
• Primary Completion: 2025-06-17
• Study Completion: 2025-06-17
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-09
• Last Update Posted: 2025-07-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prostate Cancer Long Term Outcomes	3 years	Long term outcomes of patients with newly diagnosed or recurrent disease prostate cancer or those being evaluated for radioligand therapy, who undergo 68Ga-PSMA-11PET/CT imaging for clinical management.

Secondary Outcome Measures

Name	Time	Method
Utilization of 68Ga-PSMA-1 PET/CT Imaging for Early Prostate Cancer Recurrence Detection	1.5 years	Utilization of 68Ga-PSMA-1 PET/CT imaging for early recurrence detection in patients with low PSA (\< 0.2 ng/mL).
Patient Demographic and Clinical Characteristics	1.5 years	Demographic and clinical characteristics at time of imaging for prostate cancer patients undergoing 68Ga-PSMA-11 PET/CT imaging.
Utilization of 68Ga-PSMA-11 PET/CT Imaging for Initial Staging of Prostate Cancer	1.5 years	Utilization of 68Ga-PSMA-11 PET/CT imaging for initial staging in low risk to favorable intermediate risk \[(Grade Group 1 and 2: Gleason score 6 and 7 (3+4)\] prostate cancer patients.
Clinical Impact on Prostate Cancer Staging and Radioligand Treatment Planning	1.5 years	Clinical impact of 68Ga-PSMA-11PET/CT imaging on staging and treatment planning in prostate cancer patients considered for radioligand therapy.
Differential Use across Racial and Ethnic Groups	3 years	Differential use of 68Ga-PSMA-11 PET/CT imaging across racial and ethnic groups.
Conventional Imaging	3 years	Utilization of 68Ga-PSMA-11PET/CT imaging in initial evaluation vs repeat conventional imaging in treatment planning decisions for patients with new and recurrent prostate cancer.

Trial Locations

Locations (9)

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