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

Trial Summary

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 data supports the effectiveness of the drug Piflufolastat F18 for prostate cancer?

Piflufolastat F18 is effective for prostate cancer imaging because it targets a protein called PSMA, which is found in nearly all prostate cancers, making it better than standard imaging methods for detecting cancer spread and recurrence. ^{1 2 3 4 5}

Is Piflufolastat F18 safe for use in humans?

Piflufolastat F18 is approved by the FDA for use in prostate cancer imaging, indicating it has been evaluated for safety in humans. However, specific safety data from clinical trials is not detailed in the provided research articles. ^{1 2 3 5 6}

What makes the drug Piflufolastat F18 unique for prostate cancer imaging?

Piflufolastat F18 is unique because it is a PET imaging agent specifically designed to target prostate-specific membrane antigen (PSMA), which is expressed in nearly all prostate cancers, allowing for more accurate staging and management of the disease compared to conventional imaging methods. ^{1 3 7 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for prostate cancer detection and monitoring. The main question it aims to answer is: Can the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard? Participants will be injected with a radioactive tracer called 18F-DCFPyL and be imaged on a new type of high sensitivity PET scanner for up to 3 hours

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. England 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. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

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

5. New Zealand 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. [2023]

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

Piflufolastat F 18: Diagnostic First Approval. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Diagnostic performance and safety of NMK36 (trans-1-amino-3-[18F]fluorocyclobutanecarboxylic acid)-PET/CT in primary prostate cancer: multicenter Phase IIb clinical trial. [2018]

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

N-3-[18F]fluoropropylputrescine as potential PET imaging agent for prostate and prostate derived tumors. [2016]

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

Chiral dimethylamine flutamide derivatives--modeling, synthesis, androgen receptor affinities and carbon-11 labeling. [2015]