PET Scans for Recurrent Prostate Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Brian Helfand, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Blue Earth Diagnostics

Must not be taking: X-ray contrast, Other PET radiotracers

Disqualifiers: Cystectomy, Renal failure, Salvage therapy, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are participating in another clinical trial or have received an investigational product recently, you may not be eligible.

What data supports the idea that PET Scans for Recurrent Prostate Cancer is an effective treatment?

The available research shows that PET scans using piflufolastat F 18, a type of imaging agent, are effective for detecting prostate cancer that has come back. Studies like OSPREY and CONDOR have shown that this method helps doctors better understand the stage of the cancer and make more informed treatment decisions. This imaging technique is becoming a standard practice because it provides clearer images of cancer spread compared to older methods. This means doctors can plan more effective treatments for patients with recurrent prostate cancer.

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What safety data is available for PET scans using Flotufolastat F-18 or Piflufolastat F-18 in prostate cancer?

The safety data for PET scans using Flotufolastat F-18 and Piflufolastat F-18 in prostate cancer is supported by their approval as radioactive diagnostic agents. Piflufolastat F-18 (PYLARIFY) was approved in the USA on May 27, 2021, following trials like OSPREY and CONDOR, which demonstrated its clinical utility in staging and restaging prostate cancer. Flotufolastat F-18 (POSLUMA) received its first approval in the USA in May 2023. These approvals indicate that the agents have undergone rigorous evaluation for safety and efficacy in imaging PSMA-positive lesions in prostate cancer patients.

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Is the drug Flotufolastat (18F), Piflufolastat (18F) promising for recurrent prostate cancer?

Yes, Flotufolastat (18F) and Piflufolastat (18F) are promising drugs for recurrent prostate cancer. They are used in PET scans to help doctors see prostate cancer more clearly, especially when it might have spread or come back. These drugs have been approved in the USA and are becoming a standard tool for better imaging and treatment planning in prostate cancer.

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Eligibility Criteria

This trial is for men over 18 who've had prostate cancer treated with surgery, now have low PSA levels indicating a possible return of cancer, and are scheduled for a PET scan. They must be at least six months post-surgery and able to follow study procedures.

Inclusion Criteria

I am a man aged 18 or older.

I had prostate surgery for cancer with undetectable PSA after, but now my PSA is rising.

It has been over 6 months since my prostate surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of piflufolastat (18F) followed by a PET scan on Day 1, and a single dose of flotufolastat (18F) followed by a PET scan at least 24 hours later, within 10 days

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The trial compares urinary radioactivity in the same patient after using two different radioactive drugs (Piflufolastat (18F) and Flotufolastat (18F)) during PET scans to detect prostate cancer recurrence.

Group I: piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET) Experimental Treatment 2 Interventions

Each patient will be administered a single dose of piflufolastat (18F) on Day 1, followed by a PET scan. At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days, all patients will be administered a single dose of flotufolastat (18F) followed by a PET scan.

Flotufolastat (18F) is already approved in United States for the following indications:

🇺🇸 Approved in United States as Posluma for:

• Positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Tower Urology Los Angeles, CA

Urology San Antonio San Antonio, TX

Endeavor Health- Glenbrook Hospital Glenview, IL

Montefiore Medical Center Bronx, NY

More Trial Locations

Who Is Running the Clinical Trial?

Blue Earth Diagnostics Lead Sponsor

Aixial Group Collaborator

Aixial Group Industry Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. [2022] Prostate-specific membrane antigen (PSMA)-directed positron emission tomography (PET) has gained increasing interest for imaging of men affected by prostate cancer (PC). In recent years, 68Ga-labeled PSMA compounds have been widely utilized, although there is a trend towards increased utilization of 18F-labeled agents. Among others, [18F]DCFPyL (piflufolastat F 18, PYLARIFY) has been tested in multiple major trials, such as OSPREY and CONDOR, which provided robust evidence on the clinical utility of this compound for staging, restaging, and change in management. Recent explorative prospective trials have also utilized [18F]DCFPyL PET/CT for response assessment, e.g., in patients under abiraterone or enzalutamide, rendering this 18F-labeled PSMA radiotracer as an attractive biomarker for image-guided strategies in men with PC. After recent approval by the U.S. Food and Drug Administration, one may expect more widespread use, not only in the U.S., but also in Europe in the long term. In the present review, we will provide an overview of the current clinical utility of [18F]DCFPyL in various clinical settings for men with PC.

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

Piflufolastat F 18: Diagnostic First Approval. [2022] Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc., a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate specific antigen (PSA) level. This article summarizes the milestones in the development of piflufolastat F 18 leading to this approval as a radioactive diagnostic agent in prostate cancer.

3. Canada pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. [2023] Prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) is rapidly becoming widely accepted as the standard-of-care for imaging of men with prostate cancer. Labeled indications for regulatoryapproved agents include primary staging and recurrent disease in men at risk of metastases. The first commercial PSMA PET agent to become available was 18F-DCFPyL (piflufolastat F 18), a radiofluorinated small molecule with high-affinity for PSMA. The regulatory approval of 18F-DCFPyL hinged upon two key, multi-center, registration trials, OSPREY (patient population: highrisk primary staging) and CONDOR (patient population: biochemical recurrence). In this manuscript, we will (1) review key findings from the OSPREY and CONDOR trials, (2) discuss the clinical acquisition protocol we use for 18F-DCFPyL PET scanning, (3) present information on important pearls and pitfalls, (4) provide an overview of the PSMA reporting and data system (PSMA-RADS) interpretive framework, and (5) posit important future directions for research in PSMA PET. Our overall goal is to provide a brief introduction for practices and academic groups that are adopting 18F-DCFPyL PET scans for use in their patients with prostate cancer.

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

Flotufolastat F 18: Diagnostic First Approval. [2023] Flotufolastat F 18 (POSLUMA®) is an 18F-labelled radiohybrid (rh) prostate-specific membrane antigen (PSMA)-targeted imaging agent being developed by Blue Earth Diagnostics, a subsidiary of Bracco Imaging, for prostate cancer imaging. In May 2023, flotufolastat F 18 received its first approval in the USA as a radioactive diagnostic agent for positron emission tomography (PET) of PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. This article summarizes the milestones in the development of flotufolastat F 18 leading to this first approval.

5. England pubmed.ncbi.nlm.nih.gov

Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer . [2022] Label="INTRODUCTION">Accurate imaging is essential for staging prostate cancer and guiding management decisions. Conventional imaging modalities are hampered by a limited sensitivity for metastatic disease. Nearly all prostate cancers express prostate-specific membrane antigen (PSMA) and 18F-DCFPyL (piflufolastat F 18) is a new FDA-approved positron emission tomography (PET) agent that targets PSMA for improved staging of prostate cancer.

6. United States pubmed.ncbi.nlm.nih.gov

Impact of piflufolastat F-18 PSMA PET imaging on clinical decision-making in prostate cancer across disease states: A retrospective review. [2023] Piflufolastat F-18 (18F-DCFPyL) prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging is approved by the US food and drug administration for initial staging of high-risk prostate cancer, biochemical recurrence (BCR), and restaging of metastatic prostate cancer. Here, we sought to assess how its integration into clinical care may have impacted the management of patients.