Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer
Stopped early · Not applicable
Conditions studied: Stage II Prostate Carcinoma
In brief
Radiation therapy is a well-established treatment modality for clinically localized prostate cancer. Men who choose to undergo radiation treatments for prostate cancer will have to live with the side effects for many years. Attempts have been made to protect surrounding tissues while delivering high dosage of radiation to cancer. With the rectum being so close to the prostate, many patients still suffer from side effects caused by radiation injury to the rectum, especially those who received conventional external beam radiotherapy. CyberKnife is an FDA approved radiosurgical devise. Its flexible robotic arm allows radiation beams to be delivered in different directions, providing a highly conformal, uniform dose with steep dose gradients. Therefore, treatment with the CyberKnife radiosurgical system should minimize the toxicity to the surrounding structures. CyberKnife System also incorporates a dynamic tracking system to allow the robot to correct the targeting of therapeutic beams during treatment. These improvements allow for dose escalation within the prostate with less normal tissue toxicity. The purpose of this study is to estimate the proportion of patients with endoscopically detectable telangiectasia as the indication of radiation injury to the rectum, after CyberKnife Treatment for prostate cancer.
Key facts
- Study ID
- NCT01618838
- Run by
- Georgetown University
- People needed
- 4
- Starts
- 2011-02-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2018-08-22
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed adenocarcinoma of the prostate (Biopsy within one year of enrollment)
- Signed Study-Specific Consent
- PSA within 60 days of registration
- Baseline American Urological Association (AUA)/ International Prognostic Scoring System (IPSS) score of < 20
- Candidate for screening colonoscopy
- Pretreatment Colonoscopy/lower endoscopy done
You may not qualify if…
- Prior pelvic radiotherapy
- Prior radical prostate surgery
- Recent (within 5 years) or concurrent cancers other than non-melanoma skin cancer
- Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery
- Inflammatory bowel disease
Where it is running
- MedStar Georgetown University Hospital — Washington, Virginia, United States
Full record on ClinicalTrials.gov
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