18F-FluorThanatrace PET/CT Imaging for Prostate Cancer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Women, Children, Prisoners, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method to better understand prostate cancer. It uses a special tracer called [18F]FluorThanatrace to assess the activity of a protein, PARP-1 (Poly(ADP Ribose) Polymerase 1), in cancer-affected areas. The researchers aim to compare these images with actual tissue samples to evaluate the imaging's accuracy. Men diagnosed with prostate cancer, particularly those planning prostate removal or treatment of small cancer spots, might be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how this new imaging method works in people, offering participants a chance to contribute to groundbreaking advancements in prostate cancer diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this imaging method is safe for humans?

Research has shown that [18F]FluorThanatrace, a new imaging agent, was tested in earlier studies to ensure its safety for humans. These initial studies used the agent in imaging tests for cancers such as breast and ovarian cancer. While the main focus was on the agent's effectiveness, researchers also assessed its safety.

The results indicated that [18F]FluorThanatrace was generally well-tolerated, with most participants experiencing no serious side effects. No major safety issues were reported, which is promising. However, as this trial remains in the early stages, further research is necessary to fully understand its safety. It is encouraging that the agent has been used in humans before without major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-FluorThanatrace PET/CT imaging for prostate cancer because it offers a fresh approach to diagnosing and understanding the disease. Unlike traditional imaging techniques, this method uses a novel tracer, [18F]FluorThanatrace, which targets Poly(ADP Ribose) Polymerase 1 (PARP1), a protein involved in DNA repair. This imaging could provide more precise insights into tumor activity and aggressiveness, potentially leading to better-tailored treatment strategies for different stages of prostate cancer. By specifically highlighting areas with high PARP1 activity, this technique might reveal cancer behavior that standard imaging misses, making it a promising tool in the fight against prostate cancer.

What evidence suggests that this imaging technique is effective for prostate cancer?

Research has shown that [18F]FluorThanatrace creates images of PARP-1 activity, which is crucial in cancer cells. In early animal studies, [18F]FluorThanatrace specifically targeted and highlighted cancer cells. Studies in ovarian and breast cancer have supported these findings, demonstrating its potential as a biomarker, a measurable sign of cancer activity. This trial will investigate [18F]FluorThanatrace PET/CT imaging in different cohorts of prostate cancer patients, including those with Gleason 6, Gleason 7-8, and Gleason 9 or oligometastatic disease. This imaging reveals PARP-1 activity in cancerous areas, allowing comparison with other test results to enhance understanding of the disease. Although this method is still under study, early results are promising for tracking prostate cancer activity. ^{1 2 6 7 8}

Who Is on the Research Team?

Dan Pryma, MD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Are You a Good Fit for This Trial?

Men over 18 with biopsy-proven prostate cancer, who have at least one tumor lesion of 1 cm or larger. They must be recommended for a prostatectomy or oligometastectomy and willing to provide tissue samples for research. Excluded are those unable to tolerate imaging, with serious health/psychological issues, or unable to give informed consent.

Inclusion Criteria

Participants must be willing to allow use or collection of pathology tissue for research purposes

Participants must be informed of the investigational nature of the study and provide written informed consent

My prostate cancer diagnosis was confirmed through a biopsy.

Exclusion Criteria

Inability to tolerate imaging procedures

Presence of serious or unstable medical or psychological conditions that would compromise safety or successful participation in the study

Individuals who are mentally disabled

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET/CT imaging using the novel radiotracer [18F]FTT to evaluate PARP-1 activity

1 week

1 visit (in-person)

Pathology Comparison

Imaging results are compared with pathology results, including additional research assays when possible

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [18F]FluorThanatrace
• Poly(ADP Ribose) Polymerase 1

Trial Overview The study tests a new PET/CT imaging method using [18F]FluorThanatrace (FTT) to measure PARP-1 activity in primary or metastatic prostate cancer sites. The results will be compared with pathology findings from surgeries like prostatectomies.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 2 Interventions

Gleason 9 or oligometastic disease (n=10)

Group II: Cohort 2 Experimental Treatment 2 Interventions

Gleason 7-8 (n=10)

Group III: Cohort 1 Experimental Treatment 2 Interventions

Gleason 6 (n=10)

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Published Research Related to This Trial

The development of the PET radiotracer 18F-FTT for imaging PARP-1 has progressed from preclinical evaluation to first-in-human studies, showing promise as a biomarker for measuring PARP-1 levels in breast and ovarian cancer patients.

The article outlines the regulatory process for submitting an investigational new drug application to the FDA and emphasizes the need for a commercialization strategy to facilitate multicenter clinical trials for future approval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of 18F Fluorthanatrace: A PET Radiotracer for Imaging Poly (ADP-Ribose) Polymerase-1. Lee, HS., Schwarz, SW., Schubert, EK., et al.[2023]

Citations

1. jnm.snmjournals.org jnm.snmjournals.org/content/63/supplement_2/2267

Evaluation of in vivo PARP-1 Expression with 18F ... We report the first clinical trial of non-invasive in vivo assessment of PARP-1 expression in men with prostate cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8830434/

A PET Radiotracer for Imaging Poly (ADP-Ribose) Polymerase-1 Fluorine 18 fluorthanatrace(18F-FTT) showed PARP-1 specific uptake in preclinical models of cancer. □ In both ovarian and breast cancer trials, ...

3. nature.com nature.com/articles/s43856-025-00791-0

[18F]FluorThanatrace PET imaging as a biomarker of ... Here, we evaluate a radiolabeled PARPi, [ 18 F]FluorThanatrace ([ 18 F]FTT), as a functional biomarker of PARPi response in breast cancer.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12012890/

[18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP- ... We first explore [18F]FTT in pre-clinical models of ovarian cancer using patient derived xenografts (PDX), followed by pilot data from a phase 2 clinical trial ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-02381

PARP-1 Expression with 18F-FluorThanatrace PET/CT in ... This trial may help test whether 18F-fluorthanatrace can image PARP-1 activity in metastatic prostate cancer and whether the imaging results can be compared ...

6. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-22-1602/711319/am/18F-FluorThanatrace-18F-FTT-PET-Imaging-of-PARP

[18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP ... [18F]FluorThanatrace ([18F]FTT) is a PARPi-analog PET radiotracer that non-invasively measures PARP-1 expression. Herein, we evaluate [18F]FTT as a biomarker to ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/66/1/34

[ 18 F]Fluorthanatrace PET in Ovarian Cancer: Comparison ... Our findings suggest that [ 18 F]FTT PET may provide unique information on ovarian cancer distinct from [ 18 F]FDG PET and commonly assessed tumor features.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0969805118301409

Preliminary evaluation of a novel 18F-labeled PARP-1 ... The first in-human studies of [18F]FluorThanatrace ([18F]FTT) at Washington University suggest that [18F]FTT uptake reflects PARP expression [20]. Recently, it ...