PYLARIFY Imaging for Prostate Cancer

(MIRROR Trial)

Not currently recruiting at 14 trial locations

Overseen By Senior Clinical Trial Manager

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Lantheus Medical Imaging

Must not be taking: Hormonal therapies

Disqualifiers: Previous prostate cancer treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a PYLARIFY PET scan can safely and accurately detect prostate cancer that may have spread beyond the prostate gland in men with favorable intermediate-risk prostate cancer. Participants will receive a PYLARIFY injection, a diagnostic imaging agent, and undergo a whole-body scan to check for cancer growth beyond the prostate. If the scan indicates cancer spread, participants might require additional tests or treatments within a few months. Ideal participants are men with confirmed favorable intermediate-risk prostate cancer who have not undergone any previous prostate cancer treatments. As a Phase 4 trial, this study uses an FDA-approved method, ensuring its effectiveness and safety while helping to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have been administered any high energy gamma-emitting radioisotope recently, you may not be eligible to participate.

What is the safety track record for PYLARIFY?

Research has shown that PYLARIFY is generally safe and well-tolerated. The FDA has already approved it for imaging prostate cancer, indicating it has passed thorough safety tests. In earlier studies, some individuals experienced mild reactions such as headaches or changes in taste, but serious side effects were rare. Most individuals do not report major problems after receiving the injection for PET scans. This makes PYLARIFY a relatively safe choice for detecting the spread of prostate cancer. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard imaging methods for prostate cancer, PYLARIFY is a diagnostic agent that uses a novel PET imaging technique. This approach employs a radioactive tracer specifically targeting the prostate-specific membrane antigen (PSMA), which is often overexpressed in prostate cancer cells. Researchers are excited because this targeted imaging can lead to more accurate detection and staging of prostate cancer, potentially allowing for more personalized and effective treatment plans.

What evidence suggests that PYLARIFY PET imaging is effective for detecting prostate cancer beyond the prostate gland?

Research has shown that PYLARIFY, which participants in this trial will receive, effectively detects prostate cancer that may have spread beyond the prostate. Studies have found that this imaging agent targets a protein called PSMA, often present in high amounts in prostate cancer cells. In earlier tests, PYLARIFY accurately detected cancer, even when PSA levels were low. This capability helps doctors identify cancer that might otherwise be missed. Overall, these findings support using PYLARIFY as a reliable tool for diagnosing the spread of prostate cancer. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My doctor believes I have at least 13 months to live and my cancer has specific risk factors.

My prostate cancer is at an intermediate favorable risk stage according to recent guidelines.

My prostate biopsy was done between 2 weeks and 3 months ago.

Exclusion Criteria

I haven't had certain high-energy radiation treatments recently.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of PYLARIFY injection followed by a whole-body PET/CT or PET/MRI scan

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including regular PSA blood draws, for up to 12 months after the study scan

12 months

What Are the Treatments Tested in This Trial?

Interventions

• PYLARIFY

Trial Overview 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.

How Is the Trial Designed?

Group I: PYLARIFY PET Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Lantheus Medical Imaging

Lead Sponsor

Trials

57

Recruited

4,333,000+

Published Research Related to This Trial

In a study of 72 men with biochemical recurrence of prostate cancer, 18F-DCFPyL PET/CT demonstrated a high positivity rate of 85%, which increased with higher prostate-specific antigen (PSA) levels, indicating its efficacy in detecting prostate cancer lesions.

18F-DCFPyL PET/CT identified more lesions than conventional imaging methods, leading to treatment changes in 60% of patients, highlighting its potential to significantly impact clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Evaluation of 18F-DCFPyL PET/CT in Biochemically Recurrent Prostate Cancer in an Academic Center: A Focus on Disease Localization and Changes in Management. Song, H., Harrison, C., Duan, H., et al.[2020]

In a study of 253 patients with biochemically recurrent hormone-sensitive prostate cancer, 40.7% had a change in treatment management after undergoing 18F-DCFPyL PET/CT imaging, highlighting its significant impact on clinical decision-making.

Positive findings from the 18F-DCFPyL PET/CT scan and positive pathological lymph node status were strong predictors for changing treatment plans, while a positive surgical margin was associated with a lower likelihood of management change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management impact of 18F-DCFPyL PET/CT in hormone-sensitive prostate cancer patients with biochemical recurrence after definitive treatment: a multicenter retrospective study. Meijer, D., van Leeuwen, PJ., Oosterholt, PMJ., et al.[2021]

The 18F-labeled PSMA-directed PET agent [18F]DCFPyL (PYLARIFY) has shown significant clinical utility in staging and restaging prostate cancer, supported by major trials like OSPREY and CONDOR.

Following its recent FDA approval, [18F]DCFPyL is expected to see increased adoption for imaging and management of prostate cancer, enhancing image-guided treatment strategies in both the U.S. and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. Rowe, SP., Buck, A., Bundschuh, RA., et al.[2022]

Piflufolastat F 18 (PYLARIFY®) is a newly approved diagnostic imaging agent that targets prostate-specific membrane antigen (PSMA) for use in PET scans, specifically for detecting prostate cancer lesions.

Approved in the USA on May 27, 2021, Piflufolastat F 18 is intended for men with prostate cancer who have suspected metastasis or recurrence, providing a valuable tool for guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piflufolastat F 18: Diagnostic First Approval. Keam, SJ.[2022]

The new PET agent 18F-DCFPyL, which targets prostate-specific membrane antigen (PSMA), has shown superior diagnostic accuracy compared to conventional imaging methods for staging and restaging prostate cancer, as demonstrated in the OSPREY and CONDOR clinical trials.

The use of PSMA-PET imaging is expected to significantly enhance prostate cancer management and may lead to new diagnostic and therapeutic opportunities, improving overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer . Voter, AF., Werner, RA., Pienta, KJ., et al.[2022]

18F-DCFPyL (piflufolastat F 18) is the first PSMA-targeted PET agent approved for imaging prostate cancer, demonstrating high affinity for PSMA and becoming the standard-of-care for primary staging and recurrent disease.

The approval of 18F-DCFPyL was based on two significant multi-center trials, OSPREY and CONDOR, which focused on high-risk primary staging and biochemical recurrence, respectively, highlighting its efficacy in identifying prostate cancer metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. Rowe, SP., Voter, AF., Werner, RA., et al.[2023]

Citations

1. pylarify.com pylarify.com/

Prostate Cancer Diagnostic Imaging Agent | PYLARIFY® PYLARIFY (piflufolastat F 18) is a PSMA-targeted PET imaging agent for prostate cancer. See indications and learn how PYLARIFY performs at low PSA levels.

2. pylarify.com pylarify.com/efficacy-safety/diagnostic-performance

Learn About Diagnostic Performance for PYLARIFY® PYLARIFY is a PSMA-targeted PET imaging agent for prostate cancer. Explore the clinical study results to learn more about the diagnostic performance.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37934376/

Cost-Effectiveness Modeling of Prostate-Specific ... Results: Over a lifetime horizon, piflufolastat F 18 had the greatest effectiveness in terms of LYs (6.80) and QALYs (5.33); for the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06074510

Study Details | NCT06074510 | PYLARIFY® PET/CT or ... 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 ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251554

18F-Piflufolastat PET/CT in Patients with Biochemically ... Conclusions: PSMA-targeted 18F-piflufolastat PET/CT detected recurrent disease in the prostate and prostate bed with consistent and high PPVs ( ...

6. pylarify.com pylarify.com/efficacy-safety/safety

Explore PYLARIFY® Safety Data & Side Effects PYLARIFY is a PSMA-targeted PET imaging agent for prostate cancer. Learn more about PYLARIFY safety data and adverse reactions.

7. pylarify.com pylarify.com/safety-old

Explore PYLARIFY® Safety Data & Side Effects PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/214793s000lbl.pdf

PYLARIFY® (piflufolastat F 18) injection, for intravenous use PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues.

9. mayoclinic.org mayoclinic.org/drugs-supplements/piflufolastat-f-18-intravenous-route/description/drg-20516701

Piflufolastat f 18 (intravenous route) - Side effects & uses Piflufolastat F 18 injection is used with a PET scan (positron emission tomography) of prostate-specific membrane antigen (PSMA) positive lesions in men with ...