Clinical trial NCT06655064: Registry to Evaluate Long-Term Outcomes in Patients Who Undergo 68-Ga-PSMA-11 PET/CT Imaging Evaluations
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer (Adenocarcinoma)
Keywords: PSMA
Prostate Cancer
Lead sponsor: Telix Pharmaceuticals (Innovations) Pty Limited
Sponsor class: INDUSTRY
Collaborators: name: Specialty Networks Research.
First posted: 2024-10-23
Enrollment: 500
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 500 participants will be enrolled at up to 15 investigative sites in the United States.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prostate Cancer Long Term Outcomes
timeFrame: 3 years
Secondary outcomes:
measure: Utilization of 68Ga-PSMA-1 PET/CT Imaging for Early Prostate Cancer Recurrence Detection
timeFrame: 1.5 years
measure: Patient Demographic and Clinical Characteristics
timeFrame: 1.5 years
measure: Utilization of 68Ga-PSMA-11 PET/CT Imaging for Initial Staging of Prostate Cancer
timeFrame: 1.5 years
measure: Clinical Impact on Prostate Cancer Staging and Radioligand Treatment Planning
timeFrame: 1.5 years
measure: Differential Use across Racial and Ethnic Groups
timeFrame: 3 years
measure: Conventional Imaging
timeFrame: 3 years
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Valley Urology
state: California
city: Fresno
country: United States
facility: Urology Associates of Central California
state: California
city: Grand Junction
country: United States
facility: Urological Associates of Western Colorado
state: Colorado
city: Meridian
country: United States
facility: Idaho Urologic Institute
state: Idaho
city: Royal Oak
country: United States
facility: Comprehensive Urology
state: Michigan
city: Reno
country: United States
facility: Urology Nevada
state: Nevada
city: Springfield
country: United States
facility: Oregon Urologic Institute
state: Oregon
city: Jackson
country: United States
facility: Jackson Urological Associates
state: Tennessee
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
Study officials:
affiliation: Telix Pharmaceuticals
name: Aimal Ahmed, MD
role: STUDY_DIRECTOR
References: