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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 is a Early Phase 1 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03358563
The ClinicalTrials.gov registry entry for NCT03358563 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT03358563 reports 0 study locations.
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.
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