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NCT00403221 · ClinicalTrials.gov registry record · Phase 1

Phase I - Pre-Radical Prostatectomy RTVP-1 Gene Therapy for Prostate Cancer

A Phase 1 study, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT00403221: Completed Phase 1 study, sponsored by Baylor College of Medicine.

NCT00403221 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00403221, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

The purpose of this study is to conduct a Phase I clinical trial involving in situ RTVP-1 gene therapy for prostate cancer. We will conduct necessary safety evaluations on a new adenovirus that contains the human genes for RTVP-1. This virus will then be evaluated for safety in men with prostate cancer prior to radical prostatectomy. Based on the preclinical data, we hope that this treatment will induce not only a local cytotoxic and antiangiogenic effect but also, a systemic antitumor immune response capable of eradicating micrometastatic disease (the reason for recurrence in many of these patients).

Interventions

  • GENETIC RTVP-1 Gene

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2006-08
Est. Completion 2011-04
Phase Phase 1
Baylor College of Medicine

616 total trials

What the finished NCT00403221 record still lists

NCT00403221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 1 intervention - of which RTVP-1 Gene is the first listed.

NCT00403221 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00403221 about?

NCT00403221 is a clinical study titled "Phase I - Pre-Radical Prostatectomy RTVP-1 Gene Therapy for Prostate Cancer". The purpose of this study is to conduct a Phase I clinical trial involving in situ RTVP-1 gene therapy for prostate cancer. We will conduct necessary safety evaluations on a new adenovirus that contains the human genes for RTVP-1. This virus will then be evaluated for safety in men with prostate can...

What is the current status of trial NCT00403221?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2006-08. Estimated completion is 2011-04.

What interventions are being tested in trial NCT00403221?

The interventions under investigation include: RTVP-1 Gene (GENETIC).

Who is sponsoring clinical trial NCT00403221?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00403221's enrollment target sits among peer trials

19 1716th of 2000 higher than 281 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

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Source: ClinicalTrials.gov NCT00403221, the US trial registry maintained by the National Library of Medicine. NCT00403221 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.