Prostate Cancer (Adenocarcinoma)
Conditions
Keywords
PSMA, Prostate Cancer
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.
Interventions
OTHERNone- Observational
None- Observational
Sponsors
Specialty Networks Research.
Telix Pharmaceuticals (Innovations) Pty Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Cancer Long Term Outcomes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Demographic and Clinical Characteristics | 1.5 years | Demographic and clinical characteristics at time of imaging for prostate cancer patients undergoing 68Ga-PSMA-11 PET/CT imaging. |
| Utilization of 68Ga-PSMA-11 PET/CT Imaging for Initial Staging of Prostate Cancer | 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. |
| Utilization of 68Ga-PSMA-1 PET/CT Imaging for Early Prostate Cancer Recurrence Detection | 1.5 years | Utilization of 68Ga-PSMA-1 PET/CT imaging for early recurrence detection in patients with low PSA (\< 0.2 ng/mL). |
| Differential Use across Racial and Ethnic Groups | 3 years | Differential use of 68Ga-PSMA-11 PET/CT imaging across racial and ethnic groups. |
| Conventional Imaging | 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. |
| Clinical Impact on Prostate Cancer Staging and Radioligand Treatment Planning | 1.5 years | Clinical impact of 68Ga-PSMA-11PET/CT imaging on staging and treatment planning in prostate cancer patients considered for radioligand therapy. |
Countries
United States
Outcome results
None listed