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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Men with a history of prostate cancer may be in this study. Subjects recommended for a prostatectomy or oligometastectomy will undergo PET/CT imaging using a novel radiotracer \[18F\]FTT to evaluate PARP-1 activity in known or suspected sites of primary or metastatic disease. Imaging will be compared with pathology results, including additional research assays when possible.

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 data supports the effectiveness of the drug 18F-FluorThanatrace for prostate cancer?

Research shows that 18F-FluorThanatrace is a promising tool for imaging PARP-1, a protein involved in DNA repair, which is important in prostate cancer. It has been used to measure PARP-1 expression in other cancers like breast and ovarian, suggesting it could help identify patients who might respond well to PARP inhibitor treatments. ^{1 2 3 4 5}

Is 18F-FluorThanatrace safe for use in humans?

18F-FluorThanatrace has been used in early human imaging studies for breast and ovarian cancer, suggesting it has been tested for safety in humans, but specific safety data is not detailed in the available research. ^{1 2 3 4 6}

How does 18F-FluorThanatrace PET/CT imaging differ from other treatments for prostate cancer?

18F-FluorThanatrace PET/CT imaging is unique because it uses a radiotracer to non-invasively measure the expression of PARP-1, a protein involved in DNA repair, which can help predict a patient's response to PARP inhibitor therapy. This imaging technique is different from standard treatments as it provides a way to visualize and quantify the drug-target engagement in real-time, potentially guiding personalized treatment decisions. ^{1 2 3 7 8}

Research Team

Dan Pryma, MD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Preliminary evaluation of a novel 18F-labeled PARP-1 ligand for PET imaging of PARP-1 expression in prostate cancer. [2019]

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

PARP-1 Expression Quantified by [18F]FluorThanatrace: A Biomarker of Response to PARP Inhibition Adjuvant to Radiation Therapy. [2019]

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

The Development of 18F Fluorthanatrace: A PET Radiotracer for Imaging Poly (ADP-Ribose) Polymerase-1. [2023]

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

The evolving landscape of predictive biomarkers of response to PARP inhibitors. [2021]

5. England pubmed.ncbi.nlm.nih.gov

[18F]-Labeled PARP-1 PET imaging of PSMA targeted alpha particle radiotherapy response. [2023]

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

[18F]-SuPAR: A Radiofluorinated Probe for Noninvasive Imaging of DNA Damage-Dependent Poly(ADP-ribose) Polymerase Activity. [2020]

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

In vivo visualization of PARP inhibitor pharmacodynamics. [2022]

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

BAY 1075553 PET-CT for Staging and Restaging Prostate Cancer Patients: Comparison with [18F] Fluorocholine PET-CT (Phase I Study). [2021]