Spots Global Cancer Trial Database for Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects

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Trial Identification

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

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

Study ID: NCT00918229

Conditions

Prostate Cancer

Interventions

balloon implant

Balloon implantation

Study Description

Brief Summary: 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.

Detailed Description: 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.