TERMINATED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2025-01-30
Study Completion:2025-06-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06655064

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be a biological male at birth who is ≥ 21 years of age at the time of informed consent.
  2. 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. 3. Have histopathologically confirmed prostate adenocarcinoma.
  4. 4. Have a life expectancy of ≥ 6 months as determined by the investigator.
  5. 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. 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. 7. Be willing and able to provide informed consent and comply with the protocol requirements.
  1. 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.

Contacts and Locations

Principal Investigator

Aimal Ahmed, MD
STUDY_DIRECTOR
Telix Pharmaceuticals

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

  • Aimal Ahmed, MD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2025-01-30
Study Completion Date2025-06-17

Study Record Updates

Study Start Date2025-01-30
Study Completion Date2025-06-17

Terms related to this study

Keywords Provided by Researchers

  • PSMA
  • Prostate Cancer

Additional Relevant MeSH Terms

  • Prostate Cancer (Adenocarcinoma)