Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BioProtect
This study will be a prospective, multi-center, randomized, double-arm, single blind, concurrently controlled study to assess the safety and efficacy of the balloon in prostate cancer subjects undergoing radiotherapy by means of intensity modulation radiation therapy (IMRT).
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
