Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioProtect
ClinicalTrials.gov Identifier:
NCT00918229
First received: June 9, 2009
Last updated: September 4, 2011
Last verified: September 2011
  Purpose

Primary Goal

The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine radiation therapy (XRT) treatment. Safety of the BioProtect device will be assessed by reporting adverse events.

Secondary Goal

The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum.


Condition Intervention
Prostate Cancer
Device: BioProtect biodegradable balloon implant
Procedure: Balloon implantation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: One-arm, Multi-center, International Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

Resource links provided by NLM:


Further study details as provided by BioProtect:

Primary Outcome Measures:
  • The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy will be measured in terms of reduction in isodose to anterior wall [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: BioProtect biodegradable balloon implant
    biodegradable balloon implant to extend the distance between prostate and anterior rectal wall
    Procedure: Balloon implantation
    Implantation of the balloon between the prostate and the anterior rectal wall
Detailed Description:

Primary Endpoint Parameters

The incidence of unexpected serious adverse events related to BioProtect's SpaceGuard balloon implant and/or implantation procedure:

  1. Serious Adverse Events related to the BioProtect balloon and/or implantation procedure. Serious adverse event are defined as adverse requiring operation and/or associated with prolongation of hospital stay. Serious Adverse Events will be documented in Serious Adverse Event Form.
  2. Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events will be documented in Adverse Event Form.
  3. Subjective discomfort related to the balloon and implantation procedure will be assessed by pain analogue scale.

Secondary Endpoint Parameters A 10% decrease or greater of the average rectal doses at V50 in at least 75% of the subjects after balloon implantation as compared to the doses at V50 before the balloon implantation. This will be measured by routine Dose Volume Histogram (DVH) per local hospital practice and according to the instruction regarding anatomical landmarks delineated in this protocol.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male above 45 years old and less than 85.
  • Diagnosed locally confined prostate cancer per hospital practice and definitions for local confined prostate cancer.
  • Subject is scheduled for only localized prostate XRT treatments
  • Zubrod performance status 0-1; or Karnofsy >80
  • Blood CBC and biochemistry up to two weeks before screening demonstrating:

    • Platelets ≥ 100,000 cells/mm3
    • Hemoglobin ≥ 10.0 g/dl
    • Normal values of electrolytes (sodium, potassium, calcium)
    • Normal values of the PT, PTT and INR tests.
  • Peak Uroflow rate ≥ 13ml/sec
  • Residual Urine volume Test result < 150 ml
  • Urinalysis (RBC, WBC) and urine culture
  • Subject able to comprehend and give informed consent for participation in this study and are considered by the investigator to have good compliance for the study.

Exclusion Criteria:

  • Any prior prostate resection with a compliant prostate urethra as assessed by transrectal ultrasound (TRUS)
  • Prior radical prostatectomy
  • Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer
  • Suspected extension of the prostate tumour toward the rectum as evidenced by acceptable imaging modalities used in the study site
  • Prior surgical procedure involving peri-rectal and peri-prostatic area
  • Prior radiotherapy to the pelvis, including brachytherapy at the same body organ
  • Unstable angina
  • Congestive heart failure (CHF) phase III or IV or CHF requiring hospitalization within the last 6 months prior to screening
  • Transmural myocardial (MI) infarction within the last 6 months prior to screening
  • Moderate to severe respiratory failure, hepatic failure or renal failure
  • Acute infection requiring intravenous antibiotics at the time of screening
  • Uncontrolled bleeding disorders
  • Uncontrolled diabetes mellitus
  • Known to be HIV positive or have any other immunosuppressive disorder
  • Inflammatory diseases of the perineal skin
  • Urinary tract infection or acute or chronic prostatitis
  • Uncontrolled moderate to severe urinary disorders
  • Active inflammatory bowel disease or moderate to severe gastrointestinal (GI) disorders
  • Known or suspected rectal carcinoma
  • Subjects after anterior resection of rectum or after rectal amputation
  • Concurrent participation in any other clinical study

Intra-operative exclusion criteria:

  • Irregular findings by the implanting physician before or during implantation that to the best of the implanting physician may lead to prostate compliance leading to urinary retention or other such symptoms.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918229

Locations
United States, Virginia
Virginia Commonwealth University School of Medicine, Massey Cancer Center
Richmond, Virginia, United States, 23298-0058
Sponsors and Collaborators
BioProtect
Investigators
Study Director: Yossi Muncher, Dr. BioProtect
  More Information

No publications provided

Responsible Party: BioProtect
ClinicalTrials.gov Identifier: NCT00918229     History of Changes
Other Study ID Numbers: BPI-01 (USA)
Study First Received: June 9, 2009
Last Updated: September 4, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Israel: Ministry of Health

Keywords provided by BioProtect:
Prostate
cancer
radiation
biodegradable implantable balloon
intrarectal balloon

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014