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

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ClinicalTrials.gov Identifier: NCT06074510
Recruitment Status : Recruiting
First Posted : October 10, 2023
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Piflufolastat F 18 Intravenous Solution [PYLARIFY] Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 274 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : February 8, 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: PYLARIFY PET Drug: Piflufolastat F 18 Intravenous Solution [PYLARIFY]
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
Other Names:
  • PYLARIFY
  • 18F-DCFPyL


Outcome Measures
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Primary Outcome Measures :
  1. Detection rate [ Time Frame: Day 1 ]
    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


Secondary Outcome Measures :
  1. Change in intended patient clinical management [ Time Frame: Day 30 ]
    Intended medical management plan before and after PYLARIFY PET imaging

  2. True detection rate [ Time Frame: Day 1 ]
    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.

  3. Correct localization rate [ Time Frame: up to day 90 ]
    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.

  4. Positive predictive value of PYLARIFY [ Time Frame: up to day 90 ]
    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.

  5. Sensitivity of PYLARIFY [ Time Frame: up to day 90 ]
    Sensitivity at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.

  6. Specificity of PYLARIFY [ Time Frame: up to day 90 ]
    Specificity at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.

  7. Negative predictive value of PYLARIFY [ Time Frame: up to day 90 ]
    Negative predictive value at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.

  8. Number of participants with Adverse Events [ Time Frame: Day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06074510


Contacts
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Contact: Senior Clinical Trial Manager +1(646) 975-2540 PYL4301studyinfo@lantheus.com

Locations
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United States, California
Hoag Cancer Center Recruiting
Irvine, California, United States, 92618
Contact: Danett Reynolds    949-557-0285    danett.reynolds@hoag.org   
Principal Investigator: Gary Ulaner, MD         
Tower Urology Recruiting
Los Angeles, California, United States, 90048
Contact: Shiblee Nomanee    310-854-9898 ext 168    nomanees@towerurology.com   
Contact: Terry Williams    3108549898 ext 178    williamst@towerurology.com   
Principal Investigator: David Josephson, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Yana Skorobogatova    410-955-7700    yskorob1@jhmi.edu   
Principal Investigator: Lilja Solnes, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Michael Treacy    305-542-0018    mtreacy@mgh.harvard.edu   
Principal Investigator: Ciprian Catana, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Yvette Walker    216-444-6120    walkery2@ccf.org   
Principal Investigator: Andrei Purysko, MD         
Sponsors and Collaborators
Lantheus Medical Imaging
More Information
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Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT06074510    
Other Study ID Numbers: PYL4301
First Posted: October 10, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lantheus Medical Imaging:
Prostate Cancer
Favorable Intermediate Risk
PYLARIFY
PET
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases