Using FTT PET/CT scans to evaluate PARP activity in metastatic prostate cancer
Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Patients With Metastatic Prostate Cancer
This study is testing if a new type of scan can help see how active a certain protein is in men with metastatic prostate cancer before and after they start a new treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05242744 on ClinicalTrials.gov |
What this trial studies
This observational study involves up to 30 men with metastatic prostate cancer who will undergo two FTT PET/CT scans to assess PARP activity in known cancer sites. Participants will have a baseline scan before starting a new therapy and an optional follow-up scan shortly after treatment begins. The study aims to compare imaging results with tissue samples to evaluate the effectiveness of the investigational radiotracer FTT in identifying PARP-1 expression. Treatment decisions will be made based on clinical criteria rather than the imaging results.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with histologically confirmed metastatic prostate cancer who are being considered for new therapy involving PARP inhibitors or other treatments.
Not a fit: Patients who cannot tolerate imaging procedures or have other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of PARP activity in metastatic prostate cancer, potentially leading to more effective treatment strategies.
How similar studies have performed: While this approach is novel in its specific application, similar studies using PET/CT imaging to evaluate cancer treatment responses have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Neil Taunk, MD — University of Pennsylvania
- Study coordinator: Erin Schubert, BA
- Email: erin.schubert@pennmedicine.upenn.edu
- Phone: 215-573-6569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.