18F-labeled PET Imaging for Prostate Cancer

Overseen By Majlinda Tafa, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: NYU Langone Health

Disqualifiers: Mri contraindication, Allergic to rhpsma-7.3, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the detection of early prostate cancer recurrence using a special PET scan. It targets men whose PSA levels, a marker for prostate cancer, have risen after prostate removal. Participants will undergo a PET scan with an 18F-labeled Positron Emission Tomography diagnostic agent that highlights cancer areas. A follow-up scan may occur a year later or if PSA levels rise further. The goal is to detect cancer returning earlier, allowing treatment to start sooner. Men who have had prostate surgery and noticed rising PSA levels might be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking diagnostic advancement.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this PET imaging technique is safe for prostate cancer patients?

Research has shown that the 18F-labeled PET imaging treatment, specifically using 18F-rhPSMA-7.3, is generally well-tolerated. In a large study with 747 prostate cancer patients, this treatment helped identify cancer spread. Most patients handled it well, with only a few experiencing side effects, which were rare and occurred in less than 0.4% of participants.

Another study examined the safety of 18F-rhPSMA-7.3 for detecting cancer spread before surgery. It found the treatment to be safe and effective. Overall, evidence suggests that this imaging method is safe for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 18F-labeled PET imaging for prostate cancer because it offers a more precise way to detect cancer recurrence early on. Unlike traditional imaging methods like CT or bone scans, which might miss small or hidden tumors, this advanced PET scan uses a radioactive tracer that specifically targets prostate-specific membrane antigen (PSMA), making it easier to spot cancerous cells. This precision helps doctors tailor treatment plans more effectively, potentially improving outcomes for patients who have undergone a radical prostatectomy and have rising PSA levels.

What evidence suggests that this PET imaging is effective for detecting prostate cancer recurrence?

Research has shown that a special type of scan, called 18F-rhPSMA-7.3 PET imaging, excels at detecting prostate cancer that has returned after surgery. In this trial, all participants will undergo this scan to identify cancer recurrence. One study demonstrated that this scan detected cancer spots missed by other scans. Early detection aids doctors in providing effective treatment. By identifying cancer sooner, patients can receive timely care, potentially leading to better health outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Herbert Lepor, MD

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

This trial is for men aged 18-100 who've had prostate removal surgery and now have a PSA level over 0.2 ng/ml, indicating potential cancer recurrence. It's not for those with MRI contraindications, previous allergic reactions to rhPSMA-7.3 (18F), or refusal of PET/MRI scans.

Inclusion Criteria

I am a man aged 18-100 and my PSA level rose above 0.2 ng/ml after prostate surgery.

Exclusion Criteria

Prior allergic reaction to rhPSMA-7.3 (18F)

I do not want to undergo a rhPSMA-7.3 (18F) PET/MRI scan.

Any contraindication for MRI imaging

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Imaging

Participants receive a baseline rhPSMA-7.3 (18F) MRI scan to identify disease recurrence

1 month

1 visit (in-person)

Follow-up Imaging

Participants undergo a second rhPSMA-7.3 (18F) scan if initial scan is negative, when PSA > 0.5 ng/ml or one year after the initial scan

Up to 12 months

1 visit (in-person)

Salvage Intervention

Participants with identifiable disease during the initial scan are offered salvage intervention per standard of care

Follow-up

Participants are monitored for safety and effectiveness after intervention

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent
• PET MRI Imaging

Trial Overview The study tests the timing of a diagnostic agent called rhPSMA-7.3 (18F) in combination with PET MRI imaging to detect recurrent prostate cancer after surgery. It compares the effectiveness at two different PSA levels: >0.2 ng/ml and >0.5 ng/ml or one year later.

How Is the Trial Designed?

Group I: Patients with PSA > 0.2 ng/ml following Radical Prostatectomy Experimental Treatment 2 Interventions

Men will be eligible for the study when their post-prostatectomy PSA level is initially observed to be PSA \>0.2ng/ml. All participants will receive a baseline rhPSMA-7.3 (18F) MRI scan within a month of enrollment, and the second rhPSMA-7.3 (18F) scan will be performed within a year of the initial scan. Only those participants with rhPSMA-7.3 (18F) identifiable disease during the initial scan will be offered salvage intervention per standard of care. All participants with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA\> 0.5 ng/ml or one year after the initial PET scan. The salvage intervention will be at the discretion of the investigator.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Published Research Related to This Trial

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]

Piflufolastat F 18 is a highly effective PET radiotracer for prostate cancer diagnosis, providing the highest life-years (6.80) and quality-adjusted life-years (5.33) compared to other imaging options like fluciclovine F 18 and PSMA 11.

In terms of cost-effectiveness, piflufolastat F 18 demonstrated lower incremental cost-effectiveness ratios (ICERs) than its competitors, making it a financially favorable choice for prostate cancer diagnosis in the US healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Modeling of Prostate-Specific Membrane Antigen Positron Emission Tomography with Piflufolastat F 18 for the Initial Diagnosis of Patients with Prostate Cancer in the United States. Yee, CW., Harvey, MJ., Xin, Y., et al.[2023]

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]

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]

Citations

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Detection Efficacy of 18F‐rhPSMA‐7.3 PET/CT and Impact ... Conclusion: 18F-rhPSMA-7.3 PET offered high detection efficacy in patients with biochemical recurrence after radical prostatectomy and before potential salvage ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07220720

POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 ... The goal of this study to determine if using the (18)F-rhPSMA-7.3 PET-CT scan can improve the ability to spot serious prostate cancer in ...

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Impact of 18F-flotufolastat PET on management of patients ... Results: Of 389 patients who had 18F-flotufolastat PET, 97 had sufficient MP data for evaluation. These 97 patients were comparable to the ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/early/2024/05/23/jnumed.123.267271

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

5. nature.com nature.com/articles/s41598-024-83074-3

Biochemical failure-free survival of 18F-rhPSMA-7 ... - Nature F-Flotufolastat and 18F-rhPSMA-7 PET-guided SRT result in favorable disease outcomes in patients with biochemical recurrence of prostate cancer ...

6. 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8844263/

Safety, Biodistribution, and Radiation Dosimetry of 18F- ... This first-in-humans study investigated the safety, biodistribution, and radiation dosimetry of a novel 18 F-labeled radiohybrid prostate-specific membrane ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0302283823029494

Diagnostic Performance and Safety of Positron Emission ... Overall, 18F-rhPSMA-7.3-PET/CT was well tolerated, and identified N1 and M1 disease prior to surgery in newly diagnosed PCa patients. Patient summary. In order ...

9. posluma.com posluma.com/POSLUMA_Clinical_Summary.pdf

POSLUMA® (flotufolastat F 18) injection POSLUMA SAFETY PROFILE. The safety of POSLUMA was evaluated in 747 patients with prostate cancer. The adverse reactions reported in ≥0.4% of ...