Clinical Study of the ProSpace™ Balloon System
Research type
Research Study
Full title
Clinical Protocol for the Investigation of the ProSpace™ Balloon System Pivotal Study
IRAS ID
274899
Contact name
Joyce Dunsmore
Contact email
Sponsor organisation
BioProtect Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 25 days
Research summary
The ProSpace™ Balloon System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the ProSpace™ System to reduce the radiation dose delivered to the anterior rectum. ProSpace™ is a balloon composed of a biodegradable polymer material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient’s body over time.
This Investigational Device Exemption (IDE) study will demonstrate that the ProSpace System, when used in prostate cancer patients undergoing radiotherapy by means of IMRT (Intensity Modified Radiation Therapy), reduces the radiation dose delivered to the anterior rectum. While the device holds a CE Mark in Europe, and has been implanted in over 1000 patients, it is not yet approved in the United States (US). This pivotal study is designed to determine the safety and efficacy of the balloon implant, after which the US Food and Drug Administration (FDA) will determine if the device will become available to the general public in the United States.
The study is designed as a prospective, multi-centre, randomized, double-arm, single blind, concurrently controlled study to assess the safety and efficacy of the ProSpace™ Balloon in prostate cancer subjects undergoing radiotherapy by means of IMRT.
Subjects will be randomized in a 2:1 ratio (balloon implantation : control) to receive either IMRT + prostate marking + ProSpace implantation or IMRT + prostate marking. It is planned 222 male patients aged 18 years or over, at up to 20 centres globally will be enrolled to participate in this clinical study. All participants will have prostate cancer that is locally confined or extracapsular with no posterior extension (i.e., not involving the rectum) with a planned treatment regime of radiotherapy by IMRT.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
20/EE/0030
Date of REC Opinion
12 Feb 2020
REC opinion
Further Information Favourable Opinion