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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT00403221

Public ClinicalTrials.gov record NCT00403221. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 6:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I Study of In-Situ, Neoadjuvant, Pre-Radical Prostatectomy RTVP-1 Gene Therapy in Patients With Locally Advanced Adenocarcinoma of the Prostate (SPORE)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT00403221
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Baylor College of Medicine
Other
Enrollment
19 participants

Conditions and interventions

Interventions

Genetic

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2006 (Type not available)
Primary completion
Apr 2011 (Actual)
Completion
Apr 2011 (Actual)
Last update posted
Feb 10, 2012

2006 – 2011

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Baylor College of Medicine - Scott Department of Urology Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00403221, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 10, 2012 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00403221 live on ClinicalTrials.gov.

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