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

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

Tracking Information

• First Submitted Date: October 3, 2023
• First Posted Date: October 10, 2023
• Last Update Posted Date: April 26, 2024
• Actual Study Start Date: February 8, 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 3, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 3, 2023)

• Change in intended patient clinical management [ Time Frame: Day 30 ]
  Intended medical management plan before and after PYLARIFY PET imaging
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Number of participants with Adverse Events [ Time Frame: Day 1 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Prostate Cancer

Intervention

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

Study Arms

Experimental: PYLARIFY PET

Intervention: Drug: Piflufolastat F 18 Intravenous Solution [PYLARIFY]

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 3, 2023): 274
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2026
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06074510
• Other Study ID Numbers: PYL4301
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Lantheus Medical Imaging
• Original Responsible Party: Same as current
• Current Study Sponsor: Lantheus Medical Imaging
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Lantheus Medical Imaging
• Verification Date: April 2024