Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects

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.