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

July 9, 2025 updated by: Telix Pharmaceuticals (Innovations) Pty Limited

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93720
        • Urology Associates of Central California
      • Fresno, California, United States, 93710
        • Valley Urology
    • Colorado
      • Grand Junction, Colorado, United States, 81505
        • Urological Associates of Western Colorado
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Idaho Urologic Institute
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Comprehensive Urology
    • Nevada
      • Reno, Nevada, United States, 89511
        • Urology Nevada
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Oregon Urologic Institute
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Jackson Urological Associates
    • Texas
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Approximately 500 participants will be enrolled at up to 15 investigative sites in the United States.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: Newly Diagnosed
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.
Other: None- Observational
None- Observational
Group 2: Previously Treated
Patients who have received previous treatment for prostate cancer and have and have undergone 68Ga-PSMA-11PET/CT imaging evaluation for suspected recurrence (demonstrated by elevated PSA levels).
Other: None- Observational
None- Observational
Group 3: RLT Candidates
Patients who have metastatic prostate cancer and undergone a 68Ga-PSMA-11 PET/CT imaging evaluation for the initiation of RLT.
Other: None- Observational
None- Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate Cancer Long Term Outcomes
Time Frame: 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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utilization of 68Ga-PSMA-1 PET/CT Imaging for Early Prostate Cancer Recurrence Detection
Time Frame: 1.5 years
Utilization of 68Ga-PSMA-1 PET/CT imaging for early recurrence detection in patients with low PSA (< 0.2 ng/mL).
1.5 years
Patient Demographic and Clinical Characteristics
Time Frame: 1.5 years
Demographic and clinical characteristics at time of imaging for prostate cancer patients undergoing 68Ga-PSMA-11 PET/CT imaging.
1.5 years
Utilization of 68Ga-PSMA-11 PET/CT Imaging for Initial Staging of Prostate Cancer
Time Frame: 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.
1.5 years
Clinical Impact on Prostate Cancer Staging and Radioligand Treatment Planning
Time Frame: 1.5 years
Clinical impact of 68Ga-PSMA-11PET/CT imaging on staging and treatment planning in prostate cancer patients considered for radioligand therapy.
1.5 years
Differential Use across Racial and Ethnic Groups
Time Frame: 3 years
Differential use of 68Ga-PSMA-11 PET/CT imaging across racial and ethnic groups.
3 years
Conventional Imaging
Time Frame: 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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Collaborators

Specialty Networks Research.

Investigators

  • Study Director: Aimal Ahmed, MD, Telix Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2025

Primary Completion (Actual)

June 17, 2025

Study Completion (Actual)

June 17, 2025

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68Ga-PtableSMA-11-404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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