Status:
COMPLETED
Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
Lead Sponsor:
BioProtect
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 80 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 XRT treatment. ...
Detailed Description
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 ba...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00462124
Start Date
June 1 2007
End Date
May 1 2009
Last Update
August 8 2019
Active Locations (1)
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1
Ichilov Medical Center
Tel Aviv, Israel