Status:
COMPLETED
BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
Lead Sponsor:
BioProtect
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The BioProtect Balloon Implant™ System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the ...
Detailed Description
This study will be a prospective, multi-center, randomized, double-arm, single blind, concurrently controlled study to assess the safety and efficacy of the balloon in prostate cancer subjects undergo...
Eligibility Criteria
Inclusion
- Be at least 18 years of age
- 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
- Any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years
- 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
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2021
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT03400150
Start Date
January 3 2018
End Date
December 10 2021
Last Update
February 18 2025
Active Locations (16)
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1
Western Radiation Oncology
Apple Valley, California, United States, 95008
2
KSK Medical Center
Irvine, California, United States, 92618
3
Advanced Urology Institute
Daytona Beach, Florida, United States, 32114
4
Rush University Cancer Center
Chicago, Illinois, United States, 60612