SpaceOAR System Pivotal Study

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)

Key facts

Study ID

NCT01538628

Run by

Boston Scientific Corporation

People needed

222

Starts

2012-01-01

Expected to finish

2014-07-01

Last updated by the study team

2021-03-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Subjects greater than 18 years old
• Subjects must have pathologically confirmed invasive adenocarcinoma of the prostate and must be planning to undergo IMRT
• Subjects must have clinical stage T1 or T2 as determined from a biopsy taken within 6 months of the baseline/screening visit with Gleason Score less than or equal to 7
• Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria: PSA less than or equal to 20 ng/mL,hematocrit greater than 30%,serum creatinine less than 2.0 mg/dl, serum AST and ALT less than 2.5 times upper limit of institution normal, and serum bilirubin less than 2.0 mg/dl
• Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site

You may not qualify if…

• Prostate greater than 80cc documented within 3 months preceding the Screening/Baseline visit
• Subjects with extracapsular extension of the prostate cancer, with greater than 50% of the number of biopsy cores positive for cancer, metastatic disease, other ongoing cancers which will be treated during the study, or subjects for whom pelvic lymph node radiotherapy is planned
• Subjects with any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years.
• Subjects who are indicated for androgen deprivation therapy or who have been treated with androgen therapy within the prior 3 months.

Where it is running

• Foundation for Cancer Research and Education — Phoenix, Arizona, United States
• Urological Surgeons of Northern California — Campbell, California, United States
• Radiological Associates of Sacramento — Sacramento, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Lakewood Ranch Oncology Center/21st Century Oncology — Bradenton, Florida, United States
• 21st Century Oncology — Fort Myers, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences — Baltimore, Maryland, United States
• Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center) — Owings Mills, Maryland, United States
• Northern Nevada Radiation Oncology — Reno, Nevada, United States
• CentraState Medical Center — Freehold, New Jersey, United States
• Western New York Urology Associates, LLC and D/B/A Cancer Care of WNY — Erie, Niagara, and Chautauqua County, New York, United States
• Advanced Radiation Centers of New York — Lake Success, New York, United States
• University of Rochester — Rochester, New York, United States
• Associated Medical Professionals of NY — Syracuse, New York, United States
• Upstate Medical University — Syracuse, New York, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Oregon Urology Institute — Springfield, Oregon, United States
• 21st Century Oncology — Myrtle Beach, South Carolina, United States
• Peninsula Cancer Center — Poulsbo, Washington, United States

Full record on ClinicalTrials.gov

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