FTT PET/CT in Metastatic Prostate Cancer

Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Patients With Metastatic Prostate Cancer

Up to 30 men with metastatic prostate cancer will undergo up to 2 FTT PET/CT scans to look at PARP activity in sites of known cancer. Subjects will undergo a baseline scan prior to starting new therapy and a second, optional, post-therapy scan 1-21 days after the start of treatment. Tissue from a clinical or research biopsy will be compared to imaging measures, if available.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer Metastatic
• Intervention / Treatment: Drug: [18F]FluorThanatrace

Detailed Description

Up to 30 evaluable patients with a histological diagnosis of prostate cancer with clinical evidence of metastatic disease who are being considered for new therapy or for a change in therapy with a PARP inhibitor, androgen deprivation therapy, and/or chemotherapy as part of their clinical care will be enrolled in this study. A pre-treatment 18F-FluorThanatrace ([18F]FTT) positron emission tomography/ computed tomography (PET/CT) scan will be done prior to the start of a new therapy regimen. PET/CT imaging will be used to evaluate PARP-1 expression in sites of prostate cancer using the investigational radiotracer [18F]FTT. This is an observational study in that [18F]FTT PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the [18F]FTT PET/CT results, treatment decisions will be made by the treating physicians based upon clinical criteria. After injection of [18F]FTT patients will undergo a skull base to mid-thigh scan, starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an injection of 12 mCi of [18F]FTT intravenously (approximate range for most studies is anticipated to be 8-12 mCi ). of [18F] FTT. Data will be collected to evaluate uptake of [18F]FTT in sites of prostate cancer, which will be compared with PARP-1 expression in tissue, when available. All evaluable patients may start new therapy following the [18F]FTT PET/CT scan. It is expected that due to patient preference and time considerations, approximately 80% will also undergo a second (optional) scan that will be performed approximately 1-21 days after new therapy has started. The second scan is obtained to evaluate whether the initiation of a PARP inhibitor and/or androgen deprivation therapy and/or chemotherapy alters [18F] FTT uptake.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Erin Schubert, BA; Phone Number: 215-573-6569; Email: erin.schubert@pennmedicine.upenn.edu
• Study Contact Backup: Name: Ashley Veronsky, BA; Phone Number: 215-898-4346; Email: ashley.veronsky@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania Hospital
      • Contact: Erin Schubert; Phone Number: 2155736569 215-573-6569; Email: erin.schubert@pennmedicine.upenn.edu
      • Principal Investigator: Neil Taunk, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with a histological diagnosis of prostate cancer with clinical evidence of metastatic disease who are being considered for new therapy or for a change in therapy with a PARP inhibitor, androgen deprivation therapy, and/or chemotherapy as part of their clinical care.

Description

Inclusion Criteria:

1. Participants will be ≥ 18 years of age
2. Histologically proven prostate carcinoma
3. Clinical evidence of metastatic disease with at least one lesion identified on standard of care imaging (CT, MRI, Bone Scan, FDG or other PET/CT, Ultrasound)
4. Considered a candidate for new therapy or change in therapy with PARP inhibitor therapy and/or androgen deprivation therapy (ADT) and/or chemotherapy with or without additional agents, either on a clinical trial or as part of clinical care.
5. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
2. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Metastatic prostate cancer; Men at least 18 years of age with metastatic prostate cancer may be eligible for this study .Volunteers that meet the eligibility criteria will be considered for study participation regardless of race or ethnic background. Only individuals who can understand and give informed consent will be eligible to participate in this study.	Drug: [18F]FluorThanatrace; Investigational radiopharmaceutical used with Positron Emission Tomography (PET/CT) imaging that may provide a non-invasive measurement of PARP-1 expression; Other Names: [18F]FTT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of effect size	To establish effect size of change in FTT uptake before and after systemic therapy in men with prostate cancer metastasis using [18F]FluorThanatrace ([18F]FTT)	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of PARP expression	Evaluation of PARP-1 expression in prostate cancer using measures of uptake of [18F]FTT before and after PARPi and/or androgen deprivation therapy and/or chemotherapy	21 days
Correlation with PARP-1 IHC	Correlation of [18F]FTT uptake measures with PARP-1 IHC expression in the tissue specimen, when available	6 months
Correlation with PARP-1 autoradiography	Correlation of [18F]FTT uptake measures with PARP-1 [125I]KX1 autoradiography expression in the tissue specimen, when available	6 months
Predication of clinical response	Determination of whether baseline and/or pre-/post-treatment changes in [18F]FTT uptake predict clinical response as measured by progression-free survival (PFS) and anatomic criteria on standard of care imaging	1 year

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Neil Taunk, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: PET/CT; PARP inhibitor
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: UPCC 08821; 849671 (Other Identifier: Abramson Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No