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NCT03358563 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer
A Early Phase 1 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
NCT03358563: Completed Early Phase 1 study, sponsored by University of Wisconsin, Madison.
NCT03358563 is a Early Phase 1 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03358563, a Early Phase 1 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a pilot multimodality treatment approach trial with androgen deprivation therapy in combination with docetaxel chemotherapy followed by radical prostatectomy in patients with newly diagnosed high-risk and oligometastatic prostate cancer. This study aims to evaluate the rates of complete pathologic response (pCR) at the time of prostatectomy as well as PSA response, time to PSA recurrence and safety and toxicity of the combination. This study will be heavily embedded with biomarker analyses of the tumor and tumor cells in circulation as well in the bone marrow before and after treatment and will also include imaging analyses using a novel positron emission tomography (PET) imaging technology.
Primary Outcome
Evaluate the pathologic complete response (pCR) rates in the primary tumor from patients with newly diagnosed locally advanced or oligometastatic prostate cancer treated with combination androgen deprivation therapy (ADT) and 3 cycles of docetaxel chemotherapy followed by prostatectomy.
Interventions
- DRUG Docetaxel
- DRUG Bicalutamide
- DRUG Degarelix
- RADIATION Ferumoxytol-enhanced MRI imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-01-17 |
| Est. Completion | 2022-09-02 |
| Phase | Early Phase 1 |
What the finished NCT03358563 record still lists
NCT03358563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT03358563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03358563 about?
NCT03358563 is a clinical study titled "Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer". This is a pilot multimodality treatment approach trial with androgen deprivation therapy in combination with docetaxel chemotherapy followed by radical prostatectomy in patients with newly diagnosed high-risk and oligometastatic prostate cancer. This study aims to evaluate the rates of complete path...
What is the current status of trial NCT03358563?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2018-01-17. Estimated completion is 2022-09-02.
What interventions are being tested in trial NCT03358563?
The interventions under investigation include: Docetaxel (DRUG), Bicalutamide (DRUG), Degarelix (DRUG), Ferumoxytol-enhanced MRI imaging (RADIATION).
Who is sponsoring clinical trial NCT03358563?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03358563's enrollment target sits among peer trials
30 807th of 2000 higher than 1,075 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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
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