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NCT01341652 · ClinicalTrials.gov registry record · Phase 2

Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer

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

Completed
Registry status
Phase 2
Development phase
99
Enrollment target

NCT01341652: Completed Phase 2 study, sponsored by University of Wisconsin, Madison.

NCT01341652 is a Phase 2 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 99 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01341652, a Phase 2 study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Phase 2
Development phase
99 participants
Enrollment target

Study Summary

The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. In this study the investigators will be testing the effectiveness of a vaccine that may be able to help the body fight prostate cancer.

Primary Outcome

2-year Metastasis-Free Survival (MFS) Rate with the development of metastases by conventional imaging used to define progression (as defined by RECIST 1.1 criteria). The 2-year MFS rate estimates which were obtained using the Kaplan-Meier analysis (taking into account censoring) using the intention-to-treat population.

Interventions

  • BIOLOGICAL pTVG-HP
  • BIOLOGICAL rhGM-CSF

Trial Details

FieldValue
Enrollment Target 99 participants
Start Date 2011-05-23
Est. Completion 2020-06-30
Phase Phase 2
University of Wisconsin, Madison

1,039 total trials

What the finished NCT01341652 record still lists

NCT01341652 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).

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

NCT01341652 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01341652 about?

NCT01341652 is a clinical study titled "Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer". The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. In this study the investigators will be testing the effectiveness of a vaccine that may be able to help the body...

What is the current status of trial NCT01341652?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2011-05-23. Estimated completion is 2020-06-30.

What interventions are being tested in trial NCT01341652?

The interventions under investigation include: pTVG-HP (BIOLOGICAL), rhGM-CSF (BIOLOGICAL).

Who is sponsoring clinical trial NCT01341652?

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 NCT01341652's enrollment target sits among peer trials

99 738th of 2000 higher than 1,258 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 NCT01341652, the US trial registry maintained by the National Library of Medicine. NCT01341652 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.