One-arm, Multi-center, International Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

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.