This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Prostate Cancer Diagnostic Test: PYLARIFY

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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
Estimated Study Start Date : February 2023
Estimated Primary Completion Date : December 2028
Estimated Study Completion Date : June 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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
 Diagnostic Test: PYLARIFY
PYLARIFY PET
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
 Diagnostic Test: PYLARIFY
PYLARIFY PET


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Secondary Objective 1 [ Time Frame: 5 years ]
    To understand the demographic and clinical characteristics of patients referred for PYLARIFY PET.

  2. Secondary Objective 2 [ Time Frame: 5 years ]
    To understand the impact of PYLARIFY PET results on healthcare resource utilization.

  3. Secondary Objective 3 [ Time Frame: 5 years ]
    To understand the role of PYLARIFY PET in treatment change management for newly diagnosed prostate cancer patients.

  4. 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.

  5. Secondary Objective 5 [ Time Frame: 5 years ]
    To understand racial and ethnic disparities in prostate cancer care.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Registry is specifically for prostate cancer patients (limited to biologically male).
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Biologically male patients with confirmed prostate cancer referred to undergo a PSMA PET with PYLARIFY.
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05712473


Contacts
Layout table for location contacts
Contact: Lorraine ODonnell 19143884907 lorraine.odonnell@ppsanalytics.com

Sponsors and Collaborators
PPsanalytics
Lantheus Medical Imaging
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: PPsanalytics
ClinicalTrials.gov Identifier: NCT05712473    
Other Study ID Numbers: SN-403
First Posted: February 3, 2023    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: January 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases