BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007

Not Applicable

Completed

Brief Summary: The BioProtect Balloon Implant™ 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 balloon to reduce the radiation dose delivered to the anterior rectum. The 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: This study will be a prospective, multi-center, randomized, double-arm, single blind, concurrently controlled study to assess the safety and efficacy of the balloon in prostate cancer subjects undergoing radiotherapy by means of intensity modulation radiation therapy (IMRT).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
ProSpace group	ProSpace	Marking + ProSpace implantation + IMRT
Control group	Control	Marking + IMRT

Primary Outcome Measures

Name	Time	Method
Safety Endpoint: Number of Subjects in the Balloon and Control Groups With Rectal, Device or Procedure-related Grade > 1 AEs Within 6 Months of Procedure	Within 6 months from balloon implantation	Non-inferiority in occurrence of rectal, device or procedure-related Grade \> 1 AEs within 6 months of implantation for balloon as compared to control group
Efficacy Endpoint: Number of Subjects in the Balloon Group With Reduction of >25% in Rectal Volume Receiving 70 Gy (rV70)	3 months	Observed reduction of at least \>25% in rectal volume receiving 70 Gy (rV70) in patients after spacer implantation, with efficacy of the study confirmed if \>75% of balloon recipients achieved this degree of dose reduction.

Secondary Outcome Measures

Name	Time	Method

Locations (16): Institute of Maria Skłodowska-Oncology Centre
🇵🇱
Warsaw, Poland
New York University Langone Health
🇺🇸
New York, New York, United States
Beatson West of Scotland Cancer Centre
🇬🇧
Glasgow, United Kingdom
Western Radiation Oncology
🇺🇸
Apple Valley, California, United States
Advanced Urology Institute
🇺🇸
Daytona Beach, Florida, United States
CUF Porto Instituto
🇵🇹
Porto, Portugal
Maastro
🇳🇱
Maastricht, Netherlands
Chesapeake Urology Research Associates
🇺🇸
Owings Mills, Maryland, United States
Assuta Ashdod
🇮🇱
Ashdod, Israel
Advanced Radiation Center of New York
🇺🇸
Lake Success, New York, United States
Rabin Medical Center
🇮🇱
Petah Tikva, Israel
KSK Medical Center
🇺🇸
Irvine, California, United States
Rush University Cancer Center
🇺🇸
Chicago, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
🇺🇸
Baltimore, Maryland, United States
Urology Nevada
🇺🇸
Reno, Nevada, United States
Medical University of South Carolina (MUSC)
🇺🇸
Charleston, South Carolina, United States