PYLARIFY Imaging for Prostate Cancer

(MIRROR Trial)

Recruiting at13 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Lantheus Medical Imaging

Must not be taking: Hormonal therapies

Disqualifiers: Previous prostate cancer treatment, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug PYLARIFY for prostate cancer?

PYLARIFY, also known as piflufolastat F 18, is effective for imaging prostate cancer because it targets a protein called PSMA, which is found in most prostate cancers. Studies like OSPREY and CONDOR have shown that it helps doctors better stage and manage prostate cancer by providing clearer images of the cancer's spread. ^{1 2 3 4 5}

Is PYLARIFY (piflufolastat F 18) safe for use in humans?

PYLARIFY (piflufolastat F 18) is a diagnostic imaging agent approved by the FDA for use in prostate cancer imaging, and it has been tested in multiple major trials, such as OSPREY and CONDOR, which provided evidence of its clinical utility. While the articles do not specifically mention safety concerns, the approval and widespread use suggest it is generally considered safe for its intended diagnostic purpose. ^{1 2 3 5 6}

How does the drug PYLARIFY differ from other treatments for prostate cancer?

PYLARIFY is unique because it is a diagnostic imaging agent used in PET scans to specifically target prostate-specific membrane antigen (PSMA) in prostate cancer, allowing for more accurate detection of cancer spread compared to conventional imaging methods. This can lead to better staging and management decisions for patients with suspected metastasis or recurrence. ^{1 2 3 4 6}

Research Team

Eligibility Criteria

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

I am 18 years old or older.

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.

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

Trial Timeline

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

Treatment Details

Interventions

• PYLARIFY (Cancer Imaging Agent)

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Piflufolastat F 18: Diagnostic First Approval. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer . [2022]

4. Germany 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. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. [2023]

6. United States 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. [2020]