Trial Title:
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer
NCT ID:
NCT06074510
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
Favorable Intermediate Risk
PYLARIFY
PET
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Piflufolastat F 18 Intravenous Solution [PYLARIFY]
Description:
Participants will receive a single dose of 333 MBq (9 mCi) [296 MBq-370 MBq (8 mCi - 10
mCi)] PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired
at 1 to 2 hours post-dosing
Arm group label:
PYLARIFY PET
Other name:
PYLARIFY
Other name:
18F-DCFPyL
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must have the ability to understand and sign an approved informed consent
form (ICF)
2. Patients must have the ability to understand and comply with all protocol
requirements
3. Patients must be ≥ 18 years of age
4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status
of 0 to 2
5. Patients with life expectancy of at least 13 months as determined by the
investigator
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:
- 1 intermediate risk factor (cT2b-cT2c or ISUP Grade Group 2 or PSA 10-20 ng/mL)
- ISUP Grade Group 1 or 2
- <50% biopsy cores positive (e.g., <6 of 12 cores)
Note: Date of the prostate biopsy should be no sooner that 2 weeks and no later than 3
months prior to PYLARIFY PET imaging
Exclusion Criteria:
1. Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within
5 physical half-lives prior to Day 1 (PYLARIFY imaging)
2. Previous Prostate cancer treatment including radiation, androgen deprivation
therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or
investigational therapy
3. Known hypersensitivity to the components of PYLARIFY or its analogs
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. Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging
(if performed)
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham
Address:
City:
Birmingham
Zip:
35249
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brandon Young
Phone:
205-908-7315
Email:
bayoung@uabmc.edu
Investigator:
Last name:
Soroush Rais-Bahrami, MD
Email:
Principal Investigator
Facility:
Name:
Hoag Cancer Center
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danett Reynolds
Phone:
949-557-0285
Email:
danett.reynolds@hoag.org
Investigator:
Last name:
Gary Ulaner, MD
Email:
Principal Investigator
Facility:
Name:
Tower Urology
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shiblee Nomanee
Phone:
310-854-9898
Phone ext:
168
Email:
nomanees@towerurology.com
Contact backup:
Last name:
Terry Williams
Phone:
3108549898
Phone ext:
178
Email:
williamst@towerurology.com
Investigator:
Last name:
David Josephson, MD
Email:
Principal Investigator
Facility:
Name:
University of California San Francisco
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Contact:
Last name:
Imelda Tenggara
Phone:
415-353-7348
Email:
imelda.tenggara@ucsf.edu
Investigator:
Last name:
Peter Carroll, MD
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins University
Address:
City:
Baltimore
Zip:
21205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yana Skorobogatova
Phone:
410-955-7700
Email:
yskorob1@jhmi.edu
Investigator:
Last name:
Lilja Solnes, MD
Email:
Principal Investigator
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Treacy
Phone:
305-542-0018
Email:
mtreacy@mgh.harvard.edu
Investigator:
Last name:
Ciprian Catana, MD
Email:
Principal Investigator
Facility:
Name:
Karmanos Cancer Institute Wayne State University
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kim Dobson
Phone:
313-576-9837
Email:
dobsonk@karmanos.org
Investigator:
Last name:
Elisabeth Heath, MD
Email:
Principal Investigator
Facility:
Name:
BAMF Health
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ilhana Vila
Phone:
888-870-8998
Email:
ilhana.vila@bamfhealth.com
Investigator:
Last name:
Harshad Kulkarni, MD
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yvette Walker
Phone:
216-444-6120
Email:
walkery2@ccf.org
Investigator:
Last name:
Andrei Purysko, MD
Email:
Principal Investigator
Facility:
Name:
Huntsman Cancer Institute University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sam Mitchell
Phone:
801-213-6110
Email:
sam.mitchell@hci.utah.edu
Investigator:
Last name:
Matthew Covington, MD
Email:
Principal Investigator
Start date:
February 8, 2024
Completion date:
January 2026
Lead sponsor:
Agency:
Lantheus Medical Imaging
Agency class:
Industry
Source:
Lantheus Medical Imaging
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06074510
