BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007

NCT03400150 | Completed Results FDA Device

• 1 other identifier: BP-007
• Study Type: interventional
• Target: 222
• Locations: 6 countries
• Sites: 16

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  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

Study Arms (2)

balloon group

EXPERIMENTAL

Marking + balloon implantation + IMRT

Device: balloon

Control group

SHAM COMPARATOR

Marking + IMRT

Other: Control

Interventions

balloon DEVICE

balloon implantation

balloon group

Control OTHER

Control - Marking \& IMRT are standard of care for prostate cancer - there is no study-specific intervention

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioProtect: lead

Study Sites (16)

Western Radiation Oncology

Apple Valley, California, 95008, United States

Location

KSK Medical Center

Irvine, California, 92618, United States

Location

Advanced Urology Institute

Daytona Beach, Florida, 32114, United States

Location

Rush University Cancer Center

Chicago, Illinois, 60612, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Chesapeake Urology Research Associates

Owings Mills, Maryland, 21117, United States

Location

Urology Nevada

Reno, Nevada, 89521, United States

Location

Advanced Radiation Center of New York

Lake Success, New York, 11042, United States

Location

New York University Langone Health

New York, New York, 10016, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Assuta Ashdod

Ashdod, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Maastro

Maastricht, Netherlands

Location

Institute of Maria Skłodowska-Oncology Centre

Warsaw, Poland

Location

CUF Porto Instituto

Porto, Portugal

Location

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

Related Links

• Company website

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dafna Carmi Yinon
• Organization: BioProtect

dafna@bioprotect.com

+972 (9) 7731-929

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study subjects are blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in a 2:1 ratio (balloon implantation:control)

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 17, 2018
• Study Start: January 3, 2018
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: February 18, 2025
• Results First Posted: October 30, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); PT (1); NL (1); IL (2); US (10); GB (1)