One-Arm, Multi-Center, Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
N/A
80 Years
Male
Prostate Cancer
Trial Information
One-Arm, Multi-Center, Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
Yossi Muncher, Dr.
Investigator Role:
Study Director
Investigator Affiliation:
BioProtect
Authority:
Israel: Ministry of Health
Study ID:
BP-01
NCT ID:
NCT00462124
Start Date:
June 2007
Completion Date:
February 2010
Related Keywords:
- Prostate Cancer
- Prostate
- cancer
- radiation
- biodegradable implantable balloon
- intrarectal balloon
- Prostatic Neoplasms
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