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NCT03657108 · ClinicalTrials.gov registry record · NA
CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT03657108: Clinical Trial NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03657108 is a NA study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03657108, a NA study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
A phase I single-arm open label dose escalation study to evaluate the maximum tolerated dose (MTD) and safety of Civasheet® with radical prostatectomy (RP) and adjuvant external beam radiation therapy (EBRT) in a 3+3 dose escalation design among participants with high risk prostate cancer (PCa).
Primary Outcome
MTD is defined as the highest dose of the Civasheet® not yielding unacceptable toxicity. Specifically if \> 33 % of subjects experience dose limiting toxicity (DLT) at any dose level, the dose level below that level will be considered the MTD.
Interventions
- RADIATION Civasheet 60 Gy
- RADIATION Civasheet 75 Gy
- RADIATION Adjuvant external beam radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-03-27 |
| Est. Completion | 2023-02-01 |
| Phase | NA |
Why NCT03657108 stopped before completion
NCT03657108 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which Civasheet 60 Gy is the first listed.
NCT03657108 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03657108 about?
NCT03657108 is a clinical study titled "CivaSheet With Radical Prostatectomy & Adjuvant External Beam Radiation". A phase I single-arm open label dose escalation study to evaluate the maximum tolerated dose (MTD) and safety of Civasheet® with radical prostatectomy (RP) and adjuvant external beam radiation therapy (EBRT) in a 3+3 dose escalation design among participants with high risk prostate cancer (PCa).
What is the current status of trial NCT03657108?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2018-03-27. Estimated completion is 2023-02-01.
What interventions are being tested in trial NCT03657108?
The interventions under investigation include: Civasheet 60 Gy (RADIATION), Civasheet 75 Gy (RADIATION), Adjuvant external beam radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT03657108?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03657108's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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