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NCT Number: NCT03400150

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Ashdod, Ashdod, Israel

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

balloon

Device

balloon implantation

Control

Other

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

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

BioProtect

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 17, 2018
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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