Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor request
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Specialty Networks Research. | NETWORK |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Newly Diagnosed | 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. |
| |
| Group 2: Previously Treated | Patients who have received previous treatment for prostate cancer and have and have undergone 68Ga-PSMA-11PET/CT imaging evaluation for suspected recurrence (demonstrated by elevated PSA levels). |
| |
| Group 3: RLT Candidates | Patients who have metastatic prostate cancer and undergone a 68Ga-PSMA-11 PET/CT imaging evaluation for the initiation of RLT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None- Observational | Other | None- Observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prostate Cancer Long Term Outcomes | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Utilization of 68Ga-PSMA-1 PET/CT Imaging for Early Prostate Cancer Recurrence Detection | Utilization of 68Ga-PSMA-1 PET/CT imaging for early recurrence detection in patients with low PSA (< 0.2 ng/mL). | 1.5 years |
| Patient Demographic and Clinical Characteristics |
Not provided
Inclusion Criteria:
Participants will qualify for inclusion into Cohort 1, 2, or 3 only if they meet all the following criteria.
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.
Not provided
Not provided
Not provided
Approximately 500 participants will be enrolled at up to 15 investigative sites in the United States.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aimal Ahmed, MD | Telix Pharmaceuticals (Innovations) Pty Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Urology | Fresno | California | 93710 | United States | ||
| Urology Associates of Central California |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Demographic and clinical characteristics at time of imaging for prostate cancer patients undergoing 68Ga-PSMA-11 PET/CT imaging. |
| 1.5 years |
| Utilization of 68Ga-PSMA-11 PET/CT Imaging for Initial Staging of Prostate Cancer | 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. | 1.5 years |
| Clinical Impact on Prostate Cancer Staging and Radioligand Treatment Planning | Clinical impact of 68Ga-PSMA-11PET/CT imaging on staging and treatment planning in prostate cancer patients considered for radioligand therapy. | 1.5 years |
| Differential Use across Racial and Ethnic Groups | Differential use of 68Ga-PSMA-11 PET/CT imaging across racial and ethnic groups. | 3 years |
| Conventional Imaging | 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. | 3 years |
| 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 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided