NCT05712473

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started Feb 2023

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Feb 2023Jun 2029

First Submitted

Initial submission to the registry

January 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

February 3, 2023

Status Verified

January 1, 2023

Enrollment Period

5.8 years

First QC Date

January 25, 2023

Last Update Submit

January 25, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Primary Objective

    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.

    5 years

Secondary Outcomes (5)

  • Secondary Objective 1

    5 years

  • Secondary Objective 2

    5 years

  • Secondary Objective 3

    5 years

  • Secondary Objective 4

    5 years

  • Secondary Objective 5

    5 years

Study Arms (2)

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

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

Interventions

PYLARIFYDIAGNOSTIC_TEST

PYLARIFY PET

Cohort 1Cohort 2:

Eligibility Criteria

Age21 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsRegistry is specifically for prostate cancer patients (limited to biologically male).
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Biologically male patients with confirmed prostate cancer referred to undergo a PSMA PET with PYLARIFY.

You may qualify if:

  • Biological male at birth ≥ 21 years of age
  • Histopathological confirmed prostate adenocarcinoma
  • Patients meeting the enrollment criteria for either Cohort 1 or Cohort 2:
  • 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.
  • 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
  • Life expectancy ≥ 6 months as determined by the investigator
  • Able and willing to provide informed consent and comply with the protocol requirements.

You may not qualify if:

  • Patients who are referred for PSMA PET and undergo a PSMA PET with a radioactive agent other than PYLARIFY
  • Patients who have histological evidence of neuroendocrine prostate cancer (NEPC) (small cell/ductal variant)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Lorraine ODonnell

CONTACT

19143884907lorraine.odonnell@ppsanalytics.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 3, 2023

Study Start

February 1, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

February 3, 2023

Record last verified: 2023-01