Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

Primary Endpoint Parameters The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure: 1. 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. 2. Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events will be documented in Adverse Event Form. 3. Subjective discomfort related to the balloon and implantation procedure will be assessed by pain analogue scale. Secondary Endpoint Parameters To assess the efficacy of BioProtect biodegradable balloon implant. Efficacy will be measured in terms of: 1. Increased distance between anterior rectal wall and prostate post implantation as showed by CT until last radiation treatment. 2. Noticeable reduction of isodose level to the rectum post implantation as compared to pre-implantation isodose to the rectum by XRT treatment planning software. Other Measured Observations 1. Balloon non-displacement during treatment phase as shown by CT. 2. Balloon remaining inflated during treatment phase as shown by CT. 3. Operator satisfaction from BioProtect balloon implantation procedure.