FTT PET/CT in Metastatic Prostate Cancer

NCT ID: NCT05242744

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-07-31

Brief Summary

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.

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.

Conditions

Prostate Cancer Metastatic

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

[18F]FluorThanatrace

Intervention Type: DRUG

Investigational radiopharmaceutical used with Positron Emission Tomography (PET/CT) imaging that may provide a non-invasive measurement of PARP-1 expression

Interventions

[18F]FluorThanatrace

Investigational radiopharmaceutical used with Positron Emission Tomography (PET/CT) imaging that may provide a non-invasive measurement of PARP-1 expression

Intervention Type: DRUG

Other Intervention Names

[18F]FTT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Taunk, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erin Schubert, BA

Role: CONTACT

erin.schubert@pennmedicine.upenn.edu

215-573-6569

Ashley Veronsky, BA

Role: CONTACT

ashley.veronsky@pennmedicine.upenn.edu

215-898-4346

Facility Contacts

Erin Schubert

Role: primary

erin.schubert@pennmedicine.upenn.edu

215-573-6569 ext. 2155736569

Other Identifiers

849671

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 08821

Identifier Type: -

Identifier Source: org_study_id