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Prostate CancerPhase 4MIRRORNCT06074510

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

A Phase 4 study testing Piflufolastat F 18 Intravenous Solution [PYLARIFY] in people with Prostate Cancer, run by Lantheus Medical Imaging at 14 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Piflufolastat F 18 Intravenous Solution [PYLARIFY]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
274 participants
Where
14 sitesUnited States
Study dates
8 Feb 2024to Sep 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Karmanos Cancer Institute Wayne State University

    Detroit, Michigan, 48201

  • BAMF Health

    Grand Rapids, Michigan, 49503

  • University of Iowa Health Care

    Iowa City, Iowa, 52242

  • Hoag Cancer Center

    Irvine, California, 92618

  • Tower Urology

    Los Angeles, California, 90048

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Huntsman Cancer Institute University of Utah

    Salt Lake City, Utah, 84112

  • University of California San Francisco

    San Francisco, California, 94158

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Conditions
Prostate Cancer
Being tested
Piflufolastat F 18 Intravenous Solution [PYLARIFY]
Keywords
Prostate Cancer, Favorable Intermediate Risk, PYLARIFY, PET
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Piflufolastat F 18 Intravenous Solution [PYLARIFY]Drug

    Also called PYLARIFY, 18F-DCFPyL

    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

Study groups in NCT06074510
Study groupRoleWhat they receive
PYLARIFY PETExperimentalNot described
Receives: Drug: Piflufolastat F 18 Intravenous Solution [PYLARIFY]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 1

Secondary outcomes (8)

  1. Change in intended patient clinical management

    Intended medical management plan before and after PYLARIFY PET imaging

    Measured: Day 30

  2. 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.

    Measured: Day 1

  3. 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.

    Measured: up to day 90

  4. 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.

    Measured: up to day 90

  5. Sensitivity of PYLARIFY

    Sensitivity at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.

    Measured: up to day 90

  6. Specificity of PYLARIFY

    Specificity at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.

    Measured: up to day 90

  7. 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.

    Measured: up to day 90

  8. Number of participants with Adverse Events

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start8 Feb 2024
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
274 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06074510
Sponsor's protocol ID
PYL4301
Acronym
MIRROR
Status last verified
Sep 2025
First submitted
3 Oct 2023
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Piflufolastat F 18 Intravenous Solution [PYLARIFY] in people with Prostate Cancer, run by Lantheus Medical Imaging at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection rate (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06074510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

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