- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00462124
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tel Aviv, Israel
- Ichilov Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Balloon
Implantation of a biodegradable balloon spacer (absorbable perirectal spacer)
|
biodegradable balloon implant to increase the distance between prostate and anterior rectal wall
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of Balloon Implant
Time Frame: 6 months
|
Assessed by collecting number of subjects experiencing a serious device related adverse event.
|
6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy Will be Measured in Terms of: Number of Participants With a Reduction in Radiation to the Rectum
Time Frame: 6 months
|
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.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yossi Muncher, Dr., BioProtect
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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