ProSpace™ Balloon System Pivotal Study BP-007

Study Overview
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Brief Summary
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The ProSpace™ 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 material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Detailed Description
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This study will be a prospective, multi-center, 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 intensity modulation radiation therapy (IMRT).

Official Title
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CLINICAL PROTOCOL for the INVESTIGATION Of the ProSpace™ Balloon System Pivotal Study BP-007

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: ProSpace
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age Have been histologically diagnosed with invasive adenocarcinoma of the prostate, at clinical stage T1-T3 (as determined by a biopsy taken within 9 months of the screening visit) Be scheduled for radiation therapy (XRT) by means of IMRT Exclusion Criteria: Any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years Prior radical prostatectomy Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer Prior radiotherapy to the pelvis, including brachytherapy History of prior surgery involving the rectum or anus Prior surgical procedure involving the peri-rectal and/or peri-prostatic area

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized in a 2:1 ratio (ProSpace implantation:control)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProSpace group<br>Marking + ProSpace implantation + IMRT | Device: ProSpace<br>* ProSpace balloon implantation<br>|
| Sham Comparator: Control group<br>Marking + IMRT | Other: Control<br>* Control - Marking & IMRT are standard of care for prostate cancer - there is no study-specific intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Rate of Occurrence | Rate of occurrence of Grade 1 or greater rectal adverse events and implantation procedure related adverse events through 6 months. | Duration of at least 2 days through 6 months | 
| Reduction in Rectal Radiation Exposure | Reduction of at least 25% of the volume of the rectum receiving greater or equal to 70 Gy (VRectum70) when compared to pre-implantation values. | 6 months |