SpaceOAR System Pivotal Study
Public ClinicalTrials.gov record NCT01538628. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of SpaceOAR™ System When Used to Create Space Between the Rectum and Prostate in Men Undergoing IG-IMRT for Localized Stage T1-T2 Prostate Cancer: A Randomized, Multicenter, Parallel Arm Controlled Clinical Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)
Study identification
- NCT ID
- NCT01538628
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 222 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2011
- Primary completion
- Jun 30, 2014
- Completion
- Jun 30, 2014
- Last update posted
- Mar 18, 2021
2012 – 2014
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Foundation for Cancer Research and Education | Phoenix | Arizona | 85013 | — |
| Urological Surgeons of Northern California | Campbell | California | 95008 | — |
| Radiological Associates of Sacramento | Sacramento | California | 95815 | — |
| The Urology Center of Colorado | Denver | Colorado | 80211 | — |
| Lakewood Ranch Oncology Center/21st Century Oncology | Bradenton | Florida | 34202 | — |
| 21st Century Oncology | Fort Myers | Florida | 33907 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences | Baltimore | Maryland | 21231 | — |
| Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center) | Owings Mills | Maryland | 21117 | — |
| Northern Nevada Radiation Oncology | Reno | Nevada | 89521 | — |
| CentraState Medical Center | Freehold | New Jersey | 07728 | — |
| Western New York Urology Associates, LLC and D/B/A Cancer Care of WNY | Erie, Niagara, and Chautauqua County | New York | 14267 | — |
| Advanced Radiation Centers of New York | Lake Success | New York | 11042 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Associated Medical Professionals of NY | Syracuse | New York | 13210 | — |
| Upstate Medical University | Syracuse | New York | 13210 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Oregon Urology Institute | Springfield | Oregon | 97477 | — |
| 21st Century Oncology | Myrtle Beach | South Carolina | 29577 | — |
| Peninsula Cancer Center | Poulsbo | Washington | 98370 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01538628, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 18, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01538628 live on ClinicalTrials.gov.