Magnetic Resonance-Guided High-Dose Brachytherapy (Short-Range Radiation Therapy) for Prostate Cancer
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Radiation Therapy, Prostate, MRI, Brachytherapy, Phase II, Prostate Cancer
Eligibility Criteria
INCLUSION CRITERIA: Pathologically confirmed prostate cancer with the following features: Gleason score greater than 6, or greater than T2a, or PSA greater than or equal to 10, and no evidence of bone metastases Age greater than or equal to 18 years ECOG performance status of 0 or 1 Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include routine laboratory tests or imaging studies required to establish eligibility). EXCLUSION CRITERIA: History of prior pelvic or prostate radiotherapy TURP within the last 6 months or large TURP defect Contraindication to implant procedure: Bleeding disorder Active anticoagulation at the time of implant Artificial heart valve Contraindication to MRI: Patients weighing greater than 136 kgs (weight limit for the scanner tables) Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices. Preexisting significant urinary obstructive symptoms as reflected by a high (greater than 18) International Prostate Symptom Score (IPSS) Pubic arch interference or inadequate access to perineum as determined by preliminary MRI Cognitively impaired patients who cannot give informed consent Medically Unfit for Anesthesia as defined by an anesthesiology consultant Other active malignancy (except for non-melanoma skin cancer or malignancy which was treated with curative intent at least 3 years ago with no further evidence of recurrent disease.) Other urinary or medical conditions deemed by the PI or associates to make the patient ineligible for high dose rate brachytherapy and EBRT.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
Brachy
brachytherapy