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NCT01807065 · ClinicalTrials.gov registry record · Phase 2

Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer

A Phase 2 study, sponsored by City of Hope Medical Center.

Completed
Registry status
Phase 2
Development phase
51
Enrollment target

NCT01807065: Completed Phase 2 study, sponsored by City of Hope Medical Center.

NCT01807065 is a Phase 2 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01807065, a Phase 2 study, has completed, sponsored by City of Hope Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
51 participants
Enrollment target

Study Summary

This randomized phase II trial studies how well giving sipuleucel-T with or without radiation therapy works in treating patients with hormone-resistant metastatic prostate cancer. Vaccines may help the body build an effective immune response to kill tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving sipuleucel-T vaccine is more effective with or without radiation therapy in treating prostate cancer

Primary Outcome

Estimated using the product-limit method of Kaplan and Meier. Progression is defined as one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesions; PSA increase of 25% from baseline or nadir and by 2ng/uL or gre

Interventions

  • OTHER laboratory biomarker analysis
  • RADIATION external beam radiation therapy
  • BIOLOGICAL sipuleucel-T

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2013-06-07
Est. Completion 2019-12-31
Phase Phase 2
City of Hope Medical Center

582 total trials

What the finished NCT01807065 record still lists

NCT01807065 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

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

NCT01807065 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01807065 about?

NCT01807065 is a clinical study titled "Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer". This randomized phase II trial studies how well giving sipuleucel-T with or without radiation therapy works in treating patients with hormone-resistant metastatic prostate cancer. Vaccines may help the body build an effective immune response to kill tumor cells. Radiation therapy uses high energy x ...

What is the current status of trial NCT01807065?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2013-06-07. Estimated completion is 2019-12-31.

What interventions are being tested in trial NCT01807065?

The interventions under investigation include: laboratory biomarker analysis (OTHER), external beam radiation therapy (RADIATION), sipuleucel-T (BIOLOGICAL).

Who is sponsoring clinical trial NCT01807065?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01807065's enrollment target sits among peer trials

51 1190th of 2000 higher than 806 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 NCT01807065, the US trial registry maintained by the National Library of Medicine. NCT01807065 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.