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An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT05712473
Recruitment Status : Not yet recruiting
First Posted : February 3, 2023
Last Update Posted : February 3, 2023
Sponsor:
Collaborator:
Lantheus Medical Imaging
Information provided by (Responsible Party):
PPsanalytics

Tracking Information
First Submitted Date January 25, 2023
First Posted Date February 3, 2023
Last Update Posted Date February 3, 2023
Estimated Study Start Date February 2023
Estimated Primary Completion Date December 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2023)		 Primary Objective [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 25, 2023)
  • Secondary Objective 1 [ Time Frame: 5 years ]
    To understand the demographic and clinical characteristics of patients referred for PYLARIFY PET.
  • Secondary Objective 2 [ Time Frame: 5 years ]
    To understand the impact of PYLARIFY PET results on healthcare resource utilization.
  • Secondary Objective 3 [ Time Frame: 5 years ]
    To understand the role of PYLARIFY PET in treatment change management for newly diagnosed prostate cancer patients.
  • Secondary Objective 4 [ Time Frame: 5 years ]
    To understand the utilization of PYLARIFY PET at very low PSA levels in patients with oligometastatic prostate cancer.
  • Secondary Objective 5 [ Time Frame: 5 years ]
    To understand racial and ethnic disparities in prostate cancer care.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer
Official Title A Prospective Observational Multicenter Real-World Registry Assessing the Impact of the Use of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Biologically male patients with confirmed prostate cancer referred to undergo a PSMA PET with PYLARIFY.
Condition Prostate Cancer
Intervention Diagnostic Test: PYLARIFY
PYLARIFY PET
Study Groups/Cohorts
  • Cohort 1
    Patients who are newly diagnosed with prostate cancer (and have suspected metastases) and have not yet initiated any prostate cancer treatment and are referred to undergo PYLARIFY PET
    Intervention: Diagnostic Test: PYLARIFY
  • 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
    Intervention: Diagnostic Test: PYLARIFY
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 25, 2023)		 500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2029
Estimated Primary Completion Date December 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria

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 exclusion criteria are not eligible for enrollment in this study:

  1. Patients who are referred for PSMA PET and undergo a PSMA PET with a radioactive agent other than PYLARIFY
  2. Patients who have histological evidence of neuroendocrine prostate cancer (NEPC) (small cell/ductal variant)
  3. Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety of compliance of the patient to produce reliable data or completing the study.
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Registry is specifically for prostate cancer patients (limited to biologically male).
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Lorraine ODonnell 19143884907 lorraine.odonnell@ppsanalytics.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05712473
Other Study ID Numbers SN-403
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party PPsanalytics
Original Responsible Party Same as current
Current Study Sponsor PPsanalytics
Original Study Sponsor Same as current
Collaborators Lantheus Medical Imaging
Investigators Not Provided
PRS Account PPsanalytics
Verification Date January 2023