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NCT01706458 · ClinicalTrials.gov registry record · Phase 2

Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer

A Phase 2 study, sponsored by University of Wisconsin, Madison.

Completed
Registry status
Phase 2
Development phase
18
Enrollment target

NCT01706458: Completed Phase 2 study, sponsored by University of Wisconsin, Madison.

NCT01706458 is a Phase 2 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01706458, a Phase 2 study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Phase 2
Development phase
18 participants
Enrollment target

Study Summary

This randomized pilot clinical trial studies sipuleucel-T with or without deoxyribonucleic acid (DNA) vaccine therapy in treating patients with prostate cancer that has not responded to previous treatment with hormones and has spread to other places in the body. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving sipuleucel-T vaccine works better with or without DNA vaccine therapy in treating prostate cancer.

Primary Outcome

The primary immunological goal of this study was to determine whether booster immunizations with a DNA vaccine encoding PAP could augment the number of PAP-specific effector and memory T cells following treatment with sipuleucel-T, or prolong the duration of detectable T-cell response. All subjects received a tetanus booster immunization prior to beginning the immunization series, providing a separate test of an individual's immune responsiveness. Responses to PSA, a non-target prostate specific

Interventions

  • BIOLOGICAL DNA Vaccine
  • BIOLOGICAL sipuleucel-T

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2013-05-20
Est. Completion 2020-08-13
Phase Phase 2
University of Wisconsin, Madison

1,039 total trials

What the finished NCT01706458 record still lists

NCT01706458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 2 interventions - of which DNA Vaccine is the first listed.

NCT01706458 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01706458 about?

NCT01706458 is a clinical study titled "Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer". This randomized pilot clinical trial studies sipuleucel-T with or without deoxyribonucleic acid (DNA) vaccine therapy in treating patients with prostate cancer that has not responded to previous treatment with hormones and has spread to other places in the body. Vaccines may help the body build an e...

What is the current status of trial NCT01706458?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2013-05-20. Estimated completion is 2020-08-13.

What interventions are being tested in trial NCT01706458?

The interventions under investigation include: DNA Vaccine (BIOLOGICAL), sipuleucel-T (BIOLOGICAL).

Who is sponsoring clinical trial NCT01706458?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01706458's enrollment target sits among peer trials

18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01706458, the US trial registry maintained by the National Library of Medicine. NCT01706458 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.