Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

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.