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NCT01818986 · ClinicalTrials.gov registry record · Phase 2
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01818986: Completed Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT01818986 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01818986, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically to the concurrently administered immunotherapy Sipuleucel-T and thereby significantly improve the treatment outcome for metastatic castrate resistant prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR are FDA approved therapeutic cancer treatment
Primary Outcome
To evaluate the improvement in the time to progression (TTP) of metastatic prostate cancer after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Progression will be evaluated in this study using the modified new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Committee \[JNCI 92(3):205-216, 2000\] with modifications suggested by PCWG2 \[4
Interventions
- DRUG Sipuleucel-T
- RADIATION Stereotactic Ablative Body Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-07-10 |
| Est. Completion | 2021-05-25 |
| Phase | Phase 2 |
What the finished NCT01818986 record still lists
NCT01818986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Sipuleucel-T is the first listed.
NCT01818986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01818986 about?
NCT01818986 is a clinical study titled "Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)". In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergi...
What is the current status of trial NCT01818986?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2013-07-10. Estimated completion is 2021-05-25.
What interventions are being tested in trial NCT01818986?
The interventions under investigation include: Sipuleucel-T (DRUG), Stereotactic Ablative Body Radiation (RADIATION).
Who is sponsoring clinical trial NCT01818986?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01818986's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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