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

Last updated: June 2, 2025
Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urologic Cancer

Prostate Disorders

Prostate Cancer

Treatment

None- Observational

Clinical Study ID

NCT06655064
68Ga-PtableSMA-11-404
  • Ages > 21
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 informedconsent.

  2. Have undergone a 68Ga-PSMA-11 (Illuccix or Gozellix) PET/CT imaging evaluationwithin 60 days before enrolling in the study. (Prior imaging with alternateradioactive 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 newlydiagnosed with prostate cancer and have not received any prior treatment forprostate cancer and have undergone a 68Ga-PSMA-11 PET/CT imaging evaluation toevaluate potential spread of the disease.

  6. Participants intended for enrollment in Cohort 2: Patients who have receivedprevious treatment for prostate cancer and have and have undergone 68Ga-PSMA-11PET/CT imaging evaluation for suspected recurrence (demonstrated by elevated PSAlevels). Participants intended for enrollment in Cohort 3: Patients who havemetastatic prostate cancer and undergone a 68Ga-PSMA-11 PET/CT imaging evaluationfor the initiation of RLT.

  7. Be willing and able to provide informed consent and comply with the protocolrequirements.

Exclusion

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 theInvestigator, compromises the safety of the participant, the ability of theparticipant to comply with protocol requirements, the ability of the participant tocomplete the study, or confound study outcomes by being unable to produce reliabledata over the course of the study.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: None- Observational
Phase:
Study Start date:
January 30, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Urology Associates of Central California

    Fresno, California 93720
    United States

    Active - Recruiting

  • Valley Urology

    Fresno, California 93710
    United States

    Active - Recruiting

  • Urological Associates of Western Colorado

    Grand Junction, Colorado 81505
    United States

    Site Not Available

  • Idaho Urologic Institute

    Meridian, Idaho 83642
    United States

    Active - Recruiting

  • Comprehensive Urology

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Urology Nevada

    Reno, Nevada 89511
    United States

    Active - Recruiting

  • Oregon Urologic Institute

    Springfield, Oregon 97477
    United States

    Active - Recruiting

  • Jackson Urological Associates

    Jackson, Tennessee 38301
    United States

    Active - Recruiting

  • Urology San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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