Status:
COMPLETED
Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects
Lead Sponsor:
BioProtect
Conditions:
Prostate Cancer
Eligibility:
MALE
45-85 years
Phase:
NA
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 radiation ther...
Detailed Description
Primary Endpoint Parameters The incidence of unexpected serious adverse events related to BioProtect's SpaceGuard balloon implant and/or implantation procedure: 1. Serious Adverse Events related to ...
Eligibility Criteria
Inclusion
- Adult male above 45 years old and less than 85.
- Diagnosed locally confined prostate cancer per hospital practice and definitions for local confined prostate cancer.
- Subject is scheduled for only localized prostate XRT treatments
- Zubrod performance status 0-1; or Karnofsy \>80
- Blood CBC and biochemistry up to two weeks before screening demonstrating:
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin ≥ 10.0 g/dl
- Normal values of electrolytes (sodium, potassium, calcium)
- Normal values of the PT, PTT and INR tests.
- Peak Uroflow rate ≥ 13ml/sec
- Residual Urine volume Test result \< 150 ml
- Urinalysis (RBC, WBC) and urine culture
- Subject able to comprehend and give informed consent for participation in this study and are considered by the investigator to have good compliance for the study.
Exclusion
- Any prior prostate resection with a compliant prostate urethra as assessed by transrectal ultrasound (TRUS)
- Prior radical prostatectomy
- Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer
- Suspected extension of the prostate tumour toward the rectum as evidenced by acceptable imaging modalities used in the study site
- Prior surgical procedure involving peri-rectal and peri-prostatic area
- Prior radiotherapy to the pelvis, including brachytherapy at the same body organ
- Unstable angina
- Congestive heart failure (CHF) phase III or IV or CHF requiring hospitalization within the last 6 months prior to screening
- Transmural myocardial (MI) infarction within the last 6 months prior to screening
- Moderate to severe respiratory failure, hepatic failure or renal failure
- Acute infection requiring intravenous antibiotics at the time of screening
- Uncontrolled bleeding disorders
- Uncontrolled diabetes mellitus
- Known to be HIV positive or have any other immunosuppressive disorder
- Inflammatory diseases of the perineal skin
- Urinary tract infection or acute or chronic prostatitis
- Uncontrolled moderate to severe urinary disorders
- Active inflammatory bowel disease or moderate to severe gastrointestinal (GI) disorders
- Known or suspected rectal carcinoma
- Subjects after anterior resection of rectum or after rectal amputation
- Concurrent participation in any other clinical study
- Intra-operative exclusion criteria:
- Irregular findings by the implanting physician before or during implantation that to the best of the implanting physician may lead to prostate compliance leading to urinary retention or other such symptoms.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00918229
Start Date
June 1 2009
End Date
May 1 2011
Last Update
November 20 2018
Active Locations (1)
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1
Virginia Commonwealth University School of Medicine, Massey Cancer Center
Richmond, Virginia, United States, 23298-0058