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Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by BioProtect.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
BioProtect
ClinicalTrials.gov Identifier:
NCT00462124
First received: April 16, 2007
Last updated: June 9, 2009
Last verified: June 2009
  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 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 Phase
Prostate Cancer
Device: BioProtect biodegradable balloon implant
Device: Ballon implantation
Phase 1

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, 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: [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Increased distance between anterior rectal wall [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Noticeable reduction of isodose level to the rectum [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: June 2007
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: December 2009 (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
    Device: Ballon implantation
    Implantation of the balloon between the prostate and the anterior rectal wall
Detailed Description:

Primary Endpoint Parameters

The safety endpoint is incidence of complications related to BioProtect balloon implant and 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

To assess the efficacy of BioProtect biodegradable balloon implant. Efficacy will be measured in terms of:

  1. Increased distance between anterior rectal wall and prostate post implantation as showed by CT until last radiation treatment.
  2. Noticeable reduction of isodose level to the rectum post implantation as compared to pre-implantation isodose to the rectum by XRT treatment planning software.

Other Measured Observations

  1. Balloon non-displacement during treatment phase as shown by CT.
  2. Balloon remaining inflated during treatment phase as shown by CT.
  3. Operator satisfaction from BioProtect balloon implantation procedure.
  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male aged ≤80.
  • Men with child producing potential (that are not sterile) must accept using adequate contraceptive throughout the radiotherapy phase and for at least 3 months after completion of the radiotherapy phase when ever they have heterosexual intercourse.
  • Diagnosed prostate cancer not spread outside the capsule (T1 and T2).
  • Subject is scheduled for localized prostate XRT treatments.
  • Zubrod performance status 0-1; or Karnofsy >80.
  • Pre-randomization serum PSA lower than 25 (obtained prior to any LHRH or antiandrogen therapy); or Kattan nomogram less than 15 %.
  • Subject able to comprehend and give informed consent for participation in this study.
  • Probability of lymph node involvement based on Kattan nomogram less than 15 %.
  • Normal blood CBC and biochemistry up to two weeks before screening as follow:

    • Normal CBC
    • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
    • Platelets ≥ 100,000 cells/mm3
    • Hemoglobin ≥ 10.0 g/dl
    • Adequate renal function, with serum creatinine ≤ 2.0 mg/dl
    • Adequate liver function, with serum bilirubin < 2.0 mg/dl
    • Adequate liver function with SGOT/SGPT < 2.5 x the upper normal limit
    • Normal values of the PT, PTT and INR tests.
  • Signed Informed Consent Form.

Exclusion Criteria:

  • Prior radical prostatectomy, cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer.
  • Prior radiotherapy to the pelvis, including brachytherapy at the same body organ.
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.
  • Transmural myocardial infarction within the last 6 months prior to screening.
  • Acute infection requiring intravenous antibiotics at the time of screening.
  • Bleeding disorders.
  • Uncontrolled diabetes mellitus
  • HIV positive or any other immunosuppressive disorder.
  • Renal failure (Serum creatinine >2.0 mg/dl).
  • Inflammatory diseases of the perineal skin.
  • Urinary tract infection or acute or chronic prostatitis.
  • Active inflammatory bowel disease.
  • Rectal carcinoma.
  • Subjects after anterior resection of rectum or after rectal amputation.
  • Known cognitive disorder.
  • Concurrent participation in any other clinical study.
  • Physician objection.
  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: NCT00462124

Contacts
Contact: Yossi Muncher, Dr. 972-50-858-0308 yossi@bioprotect.co.il
Contact: Shaul Shohat 972-54-542-3774 shaul@bioprotect.co.il

Locations
Israel
Ichilov Medical Center Recruiting
Tel Aviv, Israel
Contact: Eli Gez, Dr.    972-3-6973914    eliahug@tasmc.health.gov.il   
Contact: Rami Ben Yosef, Prof.    972-3-6974833      
Principal Investigator: Rami Ben-Yossef, Dr.         
Sponsors and Collaborators
BioProtect
Investigators
Study Director: Yossi Muncher, Dr. BioProtect
  More Information

No publications provided

Responsible Party: Dr. Yossi Muncher VP Clinical Affairs, BioProtect
ClinicalTrials.gov Identifier: NCT00462124     History of Changes
Other Study ID Numbers: BP-01
Study First Received: April 16, 2007
Last Updated: June 9, 2009
Health Authority: 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 November 20, 2014