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NCT00109811 · ClinicalTrials.gov registry record · Phase 2

Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
32
Enrollment target

NCT00109811: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00109811 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00109811, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
32 participants
Enrollment target

Study Summary

This phase II trial is studying how well vaccine therapy works in treating patients with recurrent prostate cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells

Primary Outcome

A response is defined as at least a 5 fold higher frequency of INF-gamma secreting CD8 T cells after vaccination than before. A patient also will be considered a responder if no specific PSA: 154-163(155L) response was found before vaccination and a specific PSA: 154-163(155L) response is identified after vaccination.

Interventions

  • OTHER laboratory biomarker analysis
  • BIOLOGICAL incomplete Freund's adjuvant
  • BIOLOGICAL PSA:154-163(155L) peptide vaccine

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2005-03
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00109811 record still lists

NCT00109811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).

The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.

NCT00109811 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00109811 about?

NCT00109811 is a clinical study titled "Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer". This phase II trial is studying how well vaccine therapy works in treating patients with recurrent prostate cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells

What is the current status of trial NCT00109811?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2005-03.

What interventions are being tested in trial NCT00109811?

The interventions under investigation include: laboratory biomarker analysis (OTHER), incomplete Freund's adjuvant (BIOLOGICAL), PSA:154-163(155L) peptide vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00109811?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00109811's enrollment target sits among peer trials

32 1563rd of 2000 higher than 423 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 NCT00109811, the US trial registry maintained by the National Library of Medicine. NCT00109811 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.