Ultralow Dose PET Imaging for Prostate Cancer

Overseen By Barbara Blanchfield

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Nuclear Imaging Institute

Must not be taking: PSMA-targeted therapy

Disqualifiers: Pregnancy, Claustrophobia, Chronic pain, 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: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using PET scans to detect and monitor prostate cancer with significantly lower radiation. Researchers aim to determine if the scans remain effective while using 10-100 times less radiation than usual. This involves a special tracer, Piflufolastat F18 (a small radioactive substance), and a new type of PET scanner. Suitable participants include those who can remain in a scanner for up to 3 hours and have not had excessive radiation exposure from other studies. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in safer cancer detection methods.

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

The trial requires that you do not take PSMA-targeted therapy (a specific type of prostate cancer treatment) while participating. Other medications are not mentioned, so it's best to discuss your current medications with the study team.

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

Research has shown that Piflufolastat F18, used in PET scans, is generally safe and well-tolerated. The FDA has already approved it for detecting prostate cancer at regular doses, indicating thorough safety testing.

Common side effects include headache, changes in taste, and pain at the injection site, but these are usually mild. This trial will use a much lower dose of radiation than usual, potentially increasing safety. Participants will receive a very small amount of the radioactive tracer 18F-DCFPyL, which is the same as Piflufolastat F18.

Overall, past research indicates the treatment is safe, and using an ultralow dose may enhance its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ultralow dose PSMA imaging for prostate cancer because it dramatically reduces radiation exposure during PET scans. Traditional PET imaging techniques for prostate cancer involve higher doses of radiation, but this approach uses a tiny amount of the radiotracer Piflufolastat F18, minimizing potential risks. The goal is to maintain high-quality imaging while optimizing the timing and reconstruction of images, which could make scans safer and more comfortable for patients without compromising diagnostic accuracy.

What evidence suggests that this ultralow dose PET imaging technique is effective for prostate cancer detection?

Studies have shown that Piflufolastat F18 can effectively change treatment plans for prostate cancer. In newly diagnosed cases, 45% of patients had their treatment plans adjusted after scans, and this number increases to 74% for cases where the cancer has returned. This imaging agent, also known as PYLARIFY, targets a marker called PSMA, often found in prostate cancer. The scans help doctors find cancer even when PSA levels, a protein made by the prostate, are low. Real-world data supports its effectiveness in managing prostate cancer, making it a promising tool for improving patient outcomes. Participants in this trial will join the ultralow dose PSMA imaging group, undergoing PET scans with significantly reduced radiation doses to evaluate image quality and optimize imaging techniques. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with prostate cancer. It's designed to test a new low-radiation PET scan technique using an injected tracer. The goal is to see if they can get clear images with much less radiation than usual.

Inclusion Criteria

Ability to provide informed consent and comply with study procedures

For female participants: Must not be pregnant or breastfeeding, Negative pregnancy test required for women of childbearing potential

Exclusion Criteria

Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total)

Pregnant or breastfeeding individuals (negative pregnancy test required)

Inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants will be injected with a radioactive tracer and imaged on a PET scanner for up to 3 hours to evaluate ultralow dose PET imaging for PSMA expression

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

12 months

Annual evaluation based on pooled images

What Are the Treatments Tested in This Trial?

Interventions

• Piflufolastat F18

Trial Overview The study tests the use of Piflufolastat F18, a radioactive tracer, in ultralow dose PET scans for detecting and monitoring prostate cancer. Researchers want to find out if lower doses can still provide high-quality images by optimizing scan timing and image processing.

How Is the Trial Designed?

Group I: ultralow dose PSMA imaging group Experimental Treatment 1 Intervention

Healthy subjects and cancer patients will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours

Who Is Running the Clinical Trial?

Nuclear Imaging Institute

Lead Sponsor

Trials

1

Recruited

200+

Akiva Mintz

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

Three novel derivatives of hydroxyflutamide were developed that show similar or improved androgen receptor (AR) binding compared to existing treatments, which could enhance the effectiveness of prostate cancer therapies.

These compounds were successfully labeled for use in positron emission tomography (PET) imaging, potentially allowing for better detection and treatment planning for AR-positive prostate cancer in vivo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chiral dimethylamine flutamide derivatives--modeling, synthesis, androgen receptor affinities and carbon-11 labeling. Jacobson, O., Laky, D., Carlson, KE., et al.[2015]

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]

The PET tracer 18F-PSMA 1007 was found to be safe and well tolerated in both healthy volunteers and prostate cancer patients, with no serious adverse events reported during the study.

In terms of diagnostic effectiveness, 18F-PSMA 1007 demonstrated high accuracy in detecting prostate cancer, achieving a sensitivity of 80% and a positive predictive value of 100% in patients with untreated preoperative prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients. Tateishi, U., Kimura, K., Tsuchiya, J., 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]

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 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]

The PET imaging agent N-3-[18F]fluoropropylputrescine shows promising results for targeting prostate tumors, with a radiochemical yield of 7-10% and a specific activity exceeding 1.1 Ci/mumol after a synthesis time of 1.5 hours.

In vivo studies in male rats demonstrated high uptake in the prostate, especially when pretreated with specific compounds, suggesting that this agent could effectively differentiate prostate tissue from surrounding muscle and blood, enhancing its potential as a diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

N-3-[18F]fluoropropylputrescine as potential PET imaging agent for prostate and prostate derived tumors. Hwang, DR., Lang, LX., Mathias, CJ., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06904313

Ultralow Dose PET Imaging for PSMA Expression The goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for prostate cancer detection and monitoring.

2. urologytimes.com urologytimes.com/view/real-world-data-show-impact-of-piflufolastat-f18-on-prostate-cancer-management

Real-world data show impact of piflufolastat F18 on ... Piflufolastat F18 scans led to treatment changes in 45% of newly diagnosed and 74% of recurrent prostate cancer cases. Clinicians reported ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37934376/

Cost-Effectiveness Modeling of Prostate-Specific ... Results: Over a lifetime horizon, piflufolastat F 18 had the greatest effectiveness in terms of LYs (6.80) and QALYs (5.33); for the comparators ...

4. pylarify.com pylarify.com/efficacy-safety/diagnostic-performance

Learn About Diagnostic Performance for PYLARIFY® PYLARIFY is a PSMA-targeted PET imaging agent for prostate cancer. Explore the clinical study results to learn more about the diagnostic performance.

5. lantheusholdings.gcs-web.com lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-presentations-featuring-pylarify

Lantheus Announces Presentations Featuring PYLARIFY ... Data highlights PYLARIFY's ability to detect recurrent prostate cancer in patients with low PSA. Real-world evidence of PYLARIFY's effectiveness in prostate ...

6. pylarify.com pylarify.com/efficacy-safety/safety

Explore PYLARIFY® Safety Data & Side Effects PYLARIFY is a PSMA-targeted PET imaging agent for prostate cancer. Learn more about PYLARIFY safety data and adverse reactions.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/214793s000lbl.pdf

PYLARIFY® (piflufolastat F 18) injection, for intravenous use A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/piflufolastat-f-18-intravenous-route/description/drg-20516701

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

9. pylarify.com pylarify.com/

Prostate Cancer Diagnostic Imaging Agent | PYLARIFY® PYLARIFY (piflufolastat F 18) is a PSMA-targeted PET imaging agent for prostate cancer. See indications and learn how PYLARIFY performs at low PSA levels.