BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007

February 4, 2025 updated by: BioProtect

CLINICAL PROTOCOL for the INVESTIGATION Of the BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ashdod, Israel
        • Assuta Ashdod
      • Petah Tikva, Israel
        • Rabin Medical Center
  • Netherlands
      • Maastricht, Netherlands
        • MAASTRO
  • Poland
      • Warsaw, Poland
        • Institute of Maria Skłodowska-Oncology Centre
  • Portugal
      • Porto, Portugal
        • CUF Porto Instituto
  • United Kingdom
      • Glasgow, United Kingdom
        • Beatson West Of Scotland Cancer Centre
  • United States
    • California
      • Apple Valley, California, United States, 95008
        • Western Radiation Oncology
      • Irvine, California, United States, 92618
        • KSK Medical Center
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Advanced Urology Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
      • Owings Mills, Maryland, United States, 21117
        • Chesapeake Urology Research Associates
    • Nevada
      • Reno, Nevada, United States, 89521
        • Urology Nevada
    • New York
      • Lake Success, New York, United States, 11042
        • Advanced Radiation Center of New York
      • New York, New York, United States, 10016
        • New York University Langone Health
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
Within 6 months from balloon implantation
Efficacy Endpoint: Number of Subjects in the Balloon Group With Reduction of >25% in Rectal Volume Receiving 70 Gy (rV70)
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioProtect

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2018

Primary Completion (Actual)

December 10, 2021

Study Completion (Actual)

December 10, 2021

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 12, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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