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PYLARIFY PET for Prostate Cancer (MIRROR Trial)
Phase 4
Recruiting
Research Sponsored by Lantheus Medical Imaging
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with life expectancy of at least 13 months as determined by the investigator 1 intermediate risk factor (cT2b-cT2c or ISUP Grade Group 2 or PSA 10-20 ng/mL)
Patients must be ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 90
Awards & highlights
MIRROR Trial Summary
This trial aims to determine if a specific PET imaging scan called PYLARIFY can safely and accurately detect prostate cancer spreading beyond the prostate gland in men with favorable intermediate risk prostate cancer. Participants will receive
Who is the study for?
This trial is for men over 18 with favorable intermediate risk prostate cancer who can understand and follow the study's procedures. They should have a life expectancy of at least 13 months, be able to perform daily activities (ECOG status 0-2), and have specific clinical or biopsy characteristics related to their cancer.Check my eligibility
What is being tested?
The trial tests if PYLARIFY PET scans can accurately detect prostate cancer spread in patients after they receive an injection of Piflufolastat F 18. Participants will undergo one whole-body PET/CT or PET/MRI scan, with possible additional tests if results indicate cancer outside the prostate.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include reactions to the PYLARIFY injection such as discomfort at the injection site, allergic reactions, and any risks associated with undergoing PET/CT or PET/MRI scans.
MIRROR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My doctor believes I have at least 13 months to live and my cancer has specific risk factors.
Select...
I am 18 years old or older.
Select...
I am able to care for myself and up to being unable to work but can still move around.
Select...
My prostate cancer is low or intermediate grade.
MIRROR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 90
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Detection rate
Secondary outcome measures
Change in intended patient clinical management
Correct localization rate
Negative predictive value of PYLARIFY
+5 moreMIRROR Trial Design
1Treatment groups
Experimental Treatment
Group I: PYLARIFY PETExperimental Treatment1 Intervention
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Who is running the clinical trial?
Lantheus Medical ImagingLead Sponsor
56 Previous Clinical Trials
4,332,402 Total Patients Enrolled
3 Trials studying Prostate Cancer
1,309 Patients Enrolled for Prostate Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for potential participants in this research study?
"Information displayed on clinicaltrials.gov indicates that this particular research endeavor is presently not seeking participants. Although it was initially shared on February 1, 2024 and last revised on the same date, there are currently 1323 alternative trials actively enrolling individuals for participation."
Answered by AI
What are the potential risks associated with PYLARIFY PET in individuals undergoing medical imaging?
"The safety rating given to the PYLARIFY PET in our evaluation at Power is 3, as this Phase 4 trial signifies that the treatment has been endorsed and deemed safe for use."
Answered by AI
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