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

April 16, 2007
June 9, 2009
June 2007
December 2009   (final data collection date for primary outcome measure)
The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure
Complete list of historical versions of study NCT00462124 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Efficacy will be measured in terms of:
  • Increased distance between anterior rectal wall
  • Noticeable reduction of isodose level to the rectum
Not Provided
Not Provided
 
Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
One-Arm, Multi-Center, Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

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.

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Prostate Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
February 2010
December 2009   (final data collection date for primary outcome measure)

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.
Male
up to 80 Years
No
Contact: Yossi Muncher, Dr. 972-50-858-0308 yossi@bioprotect.co.il
Contact: Shaul Shohat 972-54-542-3774 shaul@bioprotect.co.il
Israel
 
NCT00462124
BP-01
No
Dr. Yossi Muncher VP Clinical Affairs, BioProtect
BioProtect
Not Provided
Study Director: Yossi Muncher, Dr. BioProtect
BioProtect
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP