ACTIVE_NOT_RECRUITING

PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can safely and accurately detect the presence or absence of prostate cancer growing beyond the prostate gland in men with favorable intermediate risk prostate cancer. Participants will receive a single dose of PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours after PYLARIFY injection. Participants with positive study scan results that are suspicious for prostate cancer outside of the prostate gland may be asked to undergo additional diagnostic test(s) and/or recommend certain treatment(s) for prostate cancer within 2 to 90 days after the study scan. Participants will be monitored for up to 12 months to collecting information about treatment they receive for prostate cancer and results of regular PSA blood draws if ordered by doctors for up to 12 months after the study scan.

Official Title

A Phase 4 Open-Label Multicenter Study of PYLARIFY® PET/CT or PET/MRI in Men With Newly Diagnosed Favorable Intermediate Risk (FIR) Prostate Cancer

Quick Facts

Study Start:2024-02-08
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06074510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients must have the ability to understand and sign an approved informed consent form (ICF)
  2. 2. Patients must have the ability to understand and comply with all protocol requirements
  3. 3. Patients must be ≥ 18 years of age
  4. 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  5. 5. Patients with life expectancy of at least 13 months as determined by the investigator
  6. 6. Patients must have confirmed favorable intermediate risk (FIR) adenocarcinoma of the prostate per 2023 NCCN guidelines. FIR risk group confirmation includes all the following:
  7. * 1 intermediate risk factor (cT2b-cT2c or ISUP Grade Group 2 or PSA 10-20 ng/mL)
  8. * ISUP Grade Group 1 or 2
  9. * \<50% biopsy cores positive (e.g., \<6 of 12 cores)
  1. 1. Patients administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1 (PYLARIFY imaging)
  2. 2. Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy
  3. 3. Known hypersensitivity to the components of PYLARIFY or its analogs
  4. 4. Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or complete the study
  5. 5. Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed)

Contacts and Locations

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35249
United States
Hoag Cancer Center
Irvine, California, 92618
United States
Tower Urology
Los Angeles, California, 90048
United States
University of California San Francisco
San Francisco, California, 94158
United States
Emory University
Atlanta, Georgia, 30322
United States
University of Iowa Health Care
Iowa City, Iowa, 52242
United States
Johns Hopkins University
Baltimore, Maryland, 21205
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Karmanos Cancer Institute Wayne State University
Detroit, Michigan, 48201
United States
BAMF Health
Grand Rapids, Michigan, 49503
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Huntsman Cancer Institute University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Lantheus Medical Imaging

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-08
Study Completion Date2026-09

Study Record Updates

Study Start Date2024-02-08
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Prostate Cancer
  • Favorable Intermediate Risk
  • PYLARIFY
  • PET

Additional Relevant MeSH Terms

  • Prostate Cancer