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

Study Overview
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Brief Summary
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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
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Piflufolastat F 18 Intravenous Solution [PYLARIFY]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have the ability to understand and sign an approved informed consent form (ICF) Patients must have the ability to understand and comply with all protocol requirements Patients must be ≥ 18 years of age Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Patients with life expectancy of at least 13 months as determined by the investigator 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: 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 Known hypersensitivity to the components of PYLARIFY or its analogs 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 Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PYLARIFY PET<br> | Drug: Piflufolastat F 18 Intravenous Solution [PYLARIFY]<br>* 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<br>* Other names: 18F-DCFPyL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate | The proportion of participants with prostate cancer in whom PYLARIFY PET detected previously occult intraprostatic ISUP grade ≥3 lesions as assessed by pathology, or in whom PYLARIFY PET detected the presence of either/or extraprostatic extension, seminal vesicle invasion, regional lymph node involvement, distant metastases, divided by the number of subjects who undergo a PYLARIFY PET scan | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intended patient clinical management | Intended medical management plan before and after PYLARIFY PET imaging | Day 30 | 
| True detection rate | The percentage of participants with at least one true positive lesion identified on PYLARIFY PET imaging and confirmed by the truth standard. This measure includes patients in whom PYLARIFY PET detected previously occult intraprostatic ISUP grade ≥3 lesions as confirmed by pathology; or patients in whom PYLARIFY PET detected the presence of either/or extraprostatic extension, seminal vesicle invasion, regional lymph node involvement, distant metastases as assessed by central readers and verified by the standard of truth. | Day 1 | 
| Correct localization rate | The percentage of participants for whom there is a one-to-one correspondence on the same side between the location of at least one lesion outside of prostate capsule (extraprostatic extension, seminal vesicle invasion, pelvic lymph nodes, extrapelvic lymph nodes, extrapelvic bone or extrapelvic soft tissue lesion(s) identified on PYLARIFY PET/CT or PET/MR and the standard of truth. | up to day 90 | 
| Positive predictive value of PYLARIFY | The percentage of participants who undergo PYLARIFY PET imaging that identifies a lesion or lesions outside of the prostate capsule and have an established standard of truth. Positive predictive value does not require a one-to-one correspondence by lesion location but requires that the lesion and standard of truth be within the same anatomic region, including prostatic, pelvic, extra-pelvic or distant lesions. | up to day 90 | 
| Sensitivity of PYLARIFY | Sensitivity at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal. | up to day 90 | 
| Specificity of PYLARIFY | Specificity at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal. | up to day 90 | 
| Negative predictive value of PYLARIFY | Negative predictive value at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal. | up to day 90 | 
| Number of participants with Adverse Events |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Favorable Intermediate Risk, PYLARIFY, PET