Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects
The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine radiation therapy (XRT) treatment. Safety of the BioProtect device will be assessed by reporting adverse events.
The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum.
|Prostate Cancer||Device: BioProtect biodegradable balloon implant Procedure: Balloon implantation|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||One-arm, Multi-center, International Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy|
- The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure [ Time Frame: 6 months ]
- Efficacy will be measured in terms of reduction in isodose to anterior wall [ Time Frame: 6 months ]
|Study Start Date:||June 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Device: BioProtect biodegradable balloon implant
Primary Endpoint Parameters
The incidence of unexpected serious adverse events related to BioProtect's SpaceGuard balloon implant and/or implantation procedure:
- Serious Adverse Events related to the BioProtect balloon and/or implantation procedure. Serious adverse event are defined as adverse requiring operation and/or associated with prolongation of hospital stay. Serious Adverse Events will be documented in Serious Adverse Event Form.
- Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events will be documented in Adverse Event Form.
- Subjective discomfort related to the balloon and implantation procedure will be assessed by pain analogue scale.
Secondary Endpoint Parameters A 10% decrease or greater of the average rectal doses at V50 in at least 75% of the subjects after balloon implantation as compared to the doses at V50 before the balloon implantation. This will be measured by routine Dose Volume Histogram (DVH) per local hospital practice and according to the instruction regarding anatomical landmarks delineated in this protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918229
|United States, Virginia|
|Virginia Commonwealth University School of Medicine, Massey Cancer Center|
|Richmond, Virginia, United States, 23298-0058|
|Study Director:||Yossi Muncher, Dr.||BioProtect|