Prostate Cancer
Conditions
Brief summary
The goal of this observational research is to assess the real-world clinical utility of PYLARIFY PET through evaluation of long-term outcomes for prostate cancer patients who are eligible for a PSMA/PET scan. Participants will be enrolled at their physician's office at the time of referral for PYLARIFY PET and will be followed for up to 5 years. Data concerning their prostate cancer diagnostics and treatment will be collected at 6-month intervals.
Interventions
DIAGNOSTIC_TESTPYLARIFY
PYLARIFY PET
Sponsors
Lantheus Medical Imaging
Specialty Networks Research.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must meet all the following inclusion criteria: 1. Biological male at birth ≥ 21 years of age 2. Histopathological confirmed prostate adenocarcinoma 3. Patients meeting the enrollment criteria for either Cohort 1 or Cohort 2: 1. Cohort 1: Patients who are newly diagnosed with prostate cancer (and have suspected metastases per the physician's discretion per standard of care assessment) and have not yet initiated any prostate cancer treatment and are referred to undergo PYLARIFY PET for identification of suspected metastases. OR 2. Cohort 2: Patients who have previously received treatment for prostate cancer and are referred to undergo PYLARIFY PET or have received PYLARIFY PET for suspected recurrence of prostate cancer (based on an elevated PSA) within 60 days of consent to enroll in the registry 4. Life expectancy ≥ 6 months as determined by the investigator 5. Able and willing to provide informed consent and comply with the protocol requirements.
Exclusion criteria
Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | 5 years | The objective of this registry is to assess the real-world clinical utility of PYLARIFY PET through evaluation of long-term outcomes for prostate cancer patients who are eligible for a PSMA/PET scan and for whom PYLARIFY imaging is incorporated into treatment recommendations and management plans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Objective 1 | 5 years | To understand the demographic and clinical characteristics of patients referred for PYLARIFY PET. |
| Secondary Objective 2 | 5 years | To understand the impact of PYLARIFY PET results on healthcare resource utilization. |
| Secondary Objective 3 | 5 years | To understand the role of PYLARIFY PET in treatment change management for newly diagnosed prostate cancer patients. |
| Secondary Objective 4 | 5 years | To understand the utilization of PYLARIFY PET at very low PSA levels in patients with oligometastatic prostate cancer. |
| Secondary Objective 5 | 5 years | To understand racial and ethnic disparities in prostate cancer care. |
Countries
United States
Outcome results
None listed