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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Absorbable perirectal spacer
Sponsored by
BioProtect
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring Prostate, cancer, radiation, biodegradable implantable balloon, intrarectal balloon

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ichilov Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Balloon

Arm Description

Implantation of a biodegradable balloon spacer (absorbable perirectal spacer)

Outcomes

Primary Outcome Measures

Safety of Balloon Implant
Assessed by collecting number of subjects experiencing a serious device related adverse event.

Secondary Outcome Measures

Efficacy Will be Measured in Terms of: Number of Participants With a Reduction in Radiation to the Rectum
The space between the prostate and the rectum will be determined by Ct in subjects with prostate cancer who underwent radiotherapy and who received the balloon. The degree of increase in this space is directly related to a reduction of isodose level delivered to the rectum, and therefore a reduction in post radiation therapy rectal adverse event sequela.

Full Information

First Posted
April 16, 2007
Last Updated
June 24, 2019
Sponsor
BioProtect
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1. Study Identification

Unique Protocol Identification Number
NCT00462124
Brief Title
Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioProtect

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Primary Endpoint Parameters The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure: 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. Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events will be documented in Adverse Event Form. 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: Increased distance between anterior rectal wall and prostate post implantation as showed by CT until last radiation treatment. 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 Balloon non-displacement during treatment phase as shown by CT. Balloon remaining inflated during treatment phase as shown by CT. Operator satisfaction from BioProtect balloon implantation procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, cancer, radiation, biodegradable implantable balloon, intrarectal balloon

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balloon
Arm Type
Other
Arm Description
Implantation of a biodegradable balloon spacer (absorbable perirectal spacer)
Intervention Type
Device
Intervention Name(s)
Absorbable perirectal spacer
Intervention Description
biodegradable balloon implant to increase the distance between prostate and anterior rectal wall
Primary Outcome Measure Information:
Title
Safety of Balloon Implant
Description
Assessed by collecting number of subjects experiencing a serious device related adverse event.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Efficacy Will be Measured in Terms of: Number of Participants With a Reduction in Radiation to the Rectum
Description
The space between the prostate and the rectum will be determined by Ct in subjects with prostate cancer who underwent radiotherapy and who received the balloon. The degree of increase in this space is directly related to a reduction of isodose level delivered to the rectum, and therefore a reduction in post radiation therapy rectal adverse event sequela.
Time Frame
6 months

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yossi Muncher, Dr.
Organizational Affiliation
BioProtect
Official's Role
Study Director
Facility Information:
Facility Name
Ichilov Medical Center
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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