PET Scans for Recurrent Prostate Cancer

No longer recruiting at 9 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two different PET scans to assess their effectiveness in detecting prostate cancer recurrence after surgery. Specifically, it examines the radioactivity levels in urine following two types of scans: piflufolastat (18F) and flotufolastat (18F), both radiohybrid PSMA-targeted PET imaging agents. The trial targets men who had prostate cancer, underwent surgery, and now show low PSA levels, suggesting potential recurrence. Participants should not have received certain treatments or scans recently and must be scheduled for a PSMA PET scan by their doctor. As a Phase 4 trial, it involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

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 is the safety track record for flotufolastat (18F) and piflufolastat (18F)?

Research shows that both flotufolastat (18F) and piflufolastat (18F) have been studied for safety in humans, particularly in men with prostate cancer. The FDA has approved flotufolastat (18F) for use in PET scans to detect prostate cancer, and studies report it is generally well-tolerated with no major safety issues. Similarly, piflufolastat (18F) is FDA-approved for PET scans in prostate cancer and has demonstrated a good safety record with few side effects.

Since both are FDA-approved for similar purposes, thorough testing suggests they are generally safe for use in PET scans to detect prostate cancer. However, as with any medical treatment, some patients might experience mild side effects. It is important to consult a healthcare provider about potential risks before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for recurrent prostate cancer because they use innovative PET imaging agents, flotufolastat (18F) and piflufolastat (18F). Unlike traditional imaging methods that may not detect certain cancer recurrences early, these agents are designed to improve the accuracy and sensitivity of PET scans by specifically targeting prostate-specific membrane antigen (PSMA) on cancer cells. This targeted approach could lead to earlier and more precise detection of recurrent cancer, potentially enabling better treatment planning and outcomes for patients.

What evidence suggests that this trial's treatments could be effective for recurrent prostate cancer?

In this trial, each participant will receive both flotufolastat (18F) and piflufolastat (18F) for PET scans to detect recurrent prostate cancer. Research has shown that both flotufolastat (18F) and piflufolastat (18F) effectively identify recurrent prostate cancer using PET scans. Flotufolastat is promising because it can detect cancer even at low levels, and studies highlight its ability to find cancer that has returned in the same area. Piflufolastat is known for its accuracy in confirming cancer presence. In real-world use, piflufolastat scans have led to changes in treatment for many patients with returning prostate cancer. Both treatments help doctors identify where the cancer might be returning, leading to better treatment choices. ^{3 6 7 8 9}

Who Is on the Research Team?

Brian Helfand, M.D.

Principal Investigator

Endeavor Health NorthShore Hospital

Are You a Good Fit for This Trial?

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.

I have signed the consent form and can follow the study's requirements.

It has been over 6 months since my prostate surgery.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06617481

PET Scan Study to Detect Prostate Cancer in Patients with ... The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11557739/

Influence of fasting prior to 18F-rhPSMA-7.3 (Flotufolastat F ... In this retrospective analysis we investigated whether fasting prior to PET imaging with 18 F-rhPSMA-7.3 (Flotufolastat F-18) substantially impacts physiologic ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/66/2/230

Diuresis During 18F-Flotufolastat (rhPSMA-7.3) PET/CT ... A strategy with 18 F-flotufolastat PET/CT and concordant low-dose furosemide further reduces urinary bladder intensity and increases local recurrence detection.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.TPS347

Role of 18F-flotufolastat PET/CT imaging in men with high- ... The role of conventional imaging and piflufolastat F18 in newly diagnosed and recurrent prostate cancer patients: Preliminary observations from ...

5. posluma.com posluma.com/POSLUMA_Clinical_Summary.pdf

POSLUMA® (flotufolastat F 18) injection In SPOTLIGHT, POSLUMA (flotufolastat F 18) injection PET scans were evaluated in 389 men previously treated with definitive therapy who were ...

6. posluma.com posluma.com/safety/

Safety Learn about the established safety and tolerability of POSLUMA® (flotufolastat F 18) Injection in men with prostate cancer.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/216023s000lbl.pdf

Page 1 of 12 - accessdata.fda.gov Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218719/

True-Positive 18F-Flotufolastat Lesions in Patients with ... 18 F-flotufolastat frequently identified true-positive prostate cancer lesions in patients with negative conventional imaging.

9. mayoclinic.org mayoclinic.org/drugs-supplements/flotufolastat-f-18-intravenous-route/description/drg-20551214

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