Prostate Cancer Clinical Trial
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
Primary Goal
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.
Secondary Goal
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.
Primary Endpoint Parameters
The incidence of unexpected serious adverse events related to BioProtect's SpaceGuard balloon
implant and/or implantation procedure:
1. Serious Adverse Events related to the BioProtect balloon and/or implantation procedure
were defined by the Clinical Trials.gov definition of a serious adverse event. Serious
Adverse Events will be documented in Serious Adverse Event Form.
2. Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse
Events were documented in Adverse Event Form.
3. Subjective discomfort related to the balloon and implantation procedure were assessed by
a 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 was measured by routine Dose Volume Histogram (DVH) per
local hospital practice and according to the instructions regarding anatomical landmarks
delineated in this protocol.
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