ProSpaceâ„¢ Balloon System Pivotal Study BP-007

Inclusion Criteria:

Be at least 18 years of age
Have been histologically diagnosed with invasive adenocarcinoma of the prostate, at clinical stage T1-T3 (as determined by a biopsy taken within 9 months of the screening visit)
Be scheduled for radiation therapy (XRT) by means of IMRT

Exclusion Criteria:

Any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years
Prior radical prostatectomy
Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer
Prior radiotherapy to the pelvis, including brachytherapy
History of prior surgery involving the rectum or anus
Prior surgical procedure involving the peri-rectal and/or peri-prostatic area