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PYLARIFY Imaging 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
Must not have
Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1 (PYLARIFY imaging)
Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 90
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal 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.
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.
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.
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.
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I am 18 years old or older.
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I am able to care for myself and up to being unable to work but can still move around.
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My prostate cancer is low or intermediate grade.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had certain high-energy radiation treatments recently.
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I have had treatments for prostate cancer, including surgery or hormone therapy.
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My scans show cancer has spread to nearby tissue or lymph nodes, or other parts of my body.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Detection rate
Secondary study objectives
Change in intended patient clinical management
Correct localization rate
Negative predictive value of PYLARIFY
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PYLARIFY PETExperimental Treatment1 Intervention
Find a Location
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