PET Scans for Recurrent Prostate Cancer

Recruiting at 5 trial locations

Overseen By Phillip Davis, MD

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Blue Earth Diagnostics

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

Disqualifiers: Cystectomy, Renal failure, Salvage therapy, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

52 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 5}

Research Team

Brian Helfand, M.D.

Principal Investigator

Endeavor Health NorthShore Hospital

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 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.

My PSA level is 0.5 ng/mL or lower.

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

Treatment Details

Interventions

• Flotufolastat (18F)
• Piflufolastat (18F)

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Blue Earth Diagnostics

Lead Sponsor

Trials

43

Recruited

3,100+

Aixial Group

Collaborator

Trials

4

Recruited

90+

Aixial Group

Industry Sponsor

Trials

4

Recruited

90+

Findings from Research

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]

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]

Flotufolastat F 18 (POSLUMA®) is a newly approved imaging agent specifically designed for detecting prostate cancer lesions using PET scans, particularly in men with suspected metastasis or recurrence.

The approval in May 2023 marks a significant milestone in prostate cancer diagnostics, allowing for better identification of PSMA positive lesions in patients who are candidates for definitive therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flotufolastat F 18: Diagnostic First Approval. Heo, YA.[2023]

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 235 patients undergoing F-18 PSMA PET imaging for prostate cancer, 65.5% had PSMA-avid lesions detected, indicating its effectiveness in identifying cancer spread.

The imaging led to changes in treatment plans for 54.5% of patients in the initial staging group and 33.9% in the biochemical recurrence group, demonstrating its significant impact on clinical decision-making.

NCBI (Pubmed)

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. Arafa, AT., Jain, A., Skrobanek, P., et al.[2023]

References

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

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

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

Piflufolastat F 18: Diagnostic First Approval. [2022]

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

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

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

Flotufolastat F 18: Diagnostic First Approval. [2023]

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

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

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]