BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
NCT ID: NCT03400150
Last Updated: 2025-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
222 participants
INTERVENTIONAL
2018-01-03
2021-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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balloon group
Marking + balloon implantation + IMRT
balloon
balloon implantation
Control group
Marking + IMRT
Control
Control - Marking \& IMRT are standard of care for prostate cancer - there is no study-specific intervention
Interventions
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balloon
balloon implantation
Control
Control - Marking \& IMRT are standard of care for prostate cancer - there is no study-specific intervention
Eligibility Criteria
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Inclusion Criteria
* Have been histologically diagnosed with invasive adenocarcinoma of the prostate, at clinical stage T1-T3 (as determined by a biopsy taken within 9 months of the screening visit)
* Be scheduled for radiation therapy (XRT) by means of IMRT
Exclusion Criteria
* Prior radical prostatectomy
* Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer
* Prior radiotherapy to the pelvis, including brachytherapy
* History of prior surgery involving the rectum or anus
* Prior surgical procedure involving the peri-rectal and/or peri-prostatic area
18 Years
MALE
No
Sponsors
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BioProtect
INDUSTRY
Responsible Party
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Locations
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Western Radiation Oncology
Apple Valley, California, United States
KSK Medical Center
Irvine, California, United States
Advanced Urology Institute
Daytona Beach, Florida, United States
Rush University Cancer Center
Chicago, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Chesapeake Urology Research Associates
Owings Mills, Maryland, United States
Urology Nevada
Reno, Nevada, United States
Advanced Radiation Center of New York
Lake Success, New York, United States
New York University Langone Health
New York, New York, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Assuta Ashdod
Ashdod, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Maastro
Maastricht, , Netherlands
Institute of Maria Skłodowska-Oncology Centre
Warsaw, , Poland
CUF Porto Instituto
Porto, , Portugal
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Company website
Other Identifiers
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BP-007
Identifier Type: -
Identifier Source: org_study_id
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