Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02603965 · ClinicalTrials.gov registry record · Phase 1
Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT02603965: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT02603965 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02603965, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
This pilot phase I trial studies copper Cu 64 TP3805 (Cu-64-TP3805) positron emission tomography (PET)/computed tomography (CT) in detecting cancer in patients with prostate cancer undergoing surgery to remove the entire prostate and some of the tissue around it (radical prostatectomy). Many patients with benign lesions must undergo biopsy to test the lesion. Cu-64-TP3805 is a radioactive substance that attaches to cancer cells but not normal cells. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body where the radioactive substance is lighting up. Using Cu-64-TP3805 PET/CT scans and comparing them with cancer tissue obtained from surgery may help doctors learn whether Cu-64-TP3805 PET/CT can accurately detect prostate lesions and determine whether they are cancerous or benign, which may minimize the need for prostate biopsies.
Primary Outcome
The proportion of lesions detected with Cu-64 PET will be determined and compared with tumor maps derived from the whole mount step sectioned surgical pathology analysis of the radical prostatectomy specimen after surgery. 95% confidence intervals will be calculated. As a secondary analysis, a generalized estimating equations will be utilized to account for multiple lesions in an individual patient.
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Radical Prostatectomy
- RADIATION Copper Cu 64 TP3805
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
What the finished NCT02603965 record still lists
NCT02603965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 5 interventions - of which Computed Tomography is the first listed.
NCT02603965 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02603965 about?
NCT02603965 is a clinical study titled "Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery". This pilot phase I trial studies copper Cu 64 TP3805 (Cu-64-TP3805) positron emission tomography (PET)/computed tomography (CT) in detecting cancer in patients with prostate cancer undergoing surgery to remove the entire prostate and some of the tissue around it (radical prostatectomy). Many patient...
What is the current status of trial NCT02603965?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2013-08. Estimated completion is 2014-09.
What interventions are being tested in trial NCT02603965?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Radical Prostatectomy (PROCEDURE), Copper Cu 64 TP3805 (RADIATION).
Who is sponsoring clinical trial NCT02603965?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02603965's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01166854 · 25 participants
Characterization of Familial Myopathy and Paget Disease of Bone
- NCT01913106 · 25 participants · Phase 1
HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
- NCT02138669 · 25 participants · NA
Intacs Prescription Inserts for Keratoconus Patients
- NCT02174549 · 25 participants · Phase 1
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia