Clinical trial · Interventional
Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer
Prospective Endoscopic Safety Evaluation of Late Rectal Mucosal Injury Following CyberKnife Radiosurgery for Clinically Localized Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study only accrued 4 patients in 2 years, far below target (40). It was closed with no subject reached the primary endpoint, thus no results to publish.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage II Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CyberKnife radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- CyberKnife Radiosurgery, Colonoscopy
- description
- CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).
- interventionNames
- Radiation: CyberKnife radiosurgery
Primary outcomes (1)
- measure
- Proportion of Patients With Endoscopically Detectable-telangiectasia (VRS Grade 1 or Higher).
- timeFrame
- Planned for 7 years, collected up to 23 months
- description
- Telangiectasia is the primary outcome since it is a measure of tissue fibrosis (primary source of proctitis) and is a well-defined and measurable outcome. No patients had outcome before the trial was terminated.
Secondary outcomes (2)
- measure
- Proportion of Patients With Rectal Bleeding.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available