N/A
N=25
Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02989623 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET — 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Copper Cu 64 TP3805 (Radiation); Positron Emission Tomography and Computed Tomography Scan (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Male
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET |
25 | — |
| SECONDARY Total Incidence of Multiple Lesions in an Individual Patient |
339 | — |
Summary
This pilot phase I trial studies how well copper Cu 64 TP3805 positron emission tomography (PET) works in detecting prostate cancer in patients with persistently elevated prostate specific antigen (PSA). The copper Cu 64 TP3805 PET scan uses copper Cu 64 TP3805, a compound made of a radioactive agent attached to a molecule that looks like a hormone that binds to cancer cells to detect prostate cancer during PET scans. Copper Cu 64 TP3805 PET may be able to see tumors at an earlier stage than the standard of care.
Eligibility Criteria
Inclusion Criteria
- Ability to provide signed informed consent and willingness to comply with protocol requirements
- Persistently elevated PSA
- Scheduled for magnetic resonance imaging (MRI) fusion/transrectal ultrasound (TRUS) biopsy, followed by histology
- Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection
Exclusion Criteria
- Participating would significantly delay the scheduled standard of care therapy
- Administered a radioisotope within 10 physical half-lives prior to study drug injection
- Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study
Data sourced from ClinicalTrials.gov (NCT02989623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.