Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects

One-arm, Multi-center, International 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 radiation therapy (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.

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 the BioProtect balloon and/or implantation procedure were defined by the Clinical Trials.gov definition of a serious adverse event. 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 were documented in Adverse Event Form.
3. Subjective discomfort related to the balloon and implantation procedure were assessed by a pain analogue scale.

Secondary Endpoint Parameters A 10% decrease or greater of the average rectal doses at V50 in at least 75% of the subjects after balloon implantation as compared to the doses at V50 before the balloon implantation. This was measured by routine Dose Volume Histogram (DVH) per local hospital practice and according to the instructions regarding anatomical landmarks delineated in this protocol.

Inclusion Criteria:

• 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 Criteria:

• 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.