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

Description

The purpose of this 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. This is an observational research registry. Subjects will not be administered any medical diagnostic testing or therapy that they would not have normally undergone outside of participation in the registry.

Conditions

Prostate Cancer (Adenocarcinoma)

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Study Overview

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Study Details

Study overview

The purpose of this 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. This is an observational research registry. Subjects will not be administered any medical diagnostic testing or therapy that they would not have normally undergone outside of participation in the registry.

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

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

Condition
Prostate Cancer (Adenocarcinoma)
Intervention / Treatment

-

Contacts and Locations

Fresno

Valley Urology, Fresno, California, United States, 93710

Fresno

Urology Associates of Central California, Fresno, California, United States, 93720

Meridian

Idaho Urologic Institute, Meridian, Idaho, United States, 83642

Royal Oak

Comprehensive Urology, Royal Oak, Michigan, United States, 48073

Springfield

Oregon Urologic Institute, Springfield, Oregon, United States, 97477

San Antonio

Urology San Antonio, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Telix Pharmaceuticals (Innovations) Pty Limited,

Study Record Dates

2027-12