Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer

NCT01618838 | Terminated Results DMC

• 1 other identifier: IRB 2009-474
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Stage II Prostate Carcinoma

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Endoscopically Detectable-telangiectasia (VRS Grade 1 or Higher).

  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.

  Planned for 7 years, collected up to 23 months

Secondary Outcomes (2)

• Proportion of Patients With Rectal Bleeding.

  Planned for 7 years, collected up to 23 months

• Progression-free Survival

  Planned for 7 years, collected up to 23 months

Study Arms (1)

CyberKnife Radiosurgery, Colonoscopy

OTHER

CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).

Radiation: CyberKnife radiosurgery

Interventions

CyberKnife radiosurgery RADIATION

Treatment Planning: Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the Planning Treatment Volume (PTV) and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.

CyberKnife Radiosurgery, Colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

MedStar Georgetown University Hospital

Washington, Virginia, 22209, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Sean Collins
• Organization: Georgetown University Hospital

spc9@gunet.georgetown.edu

202-444-3062

Study Officials

• Sean P Collins, MD,PhD

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 13, 2012
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 22, 2018
• Results First Posted: April 24, 2014

Record last verified: 2018-08

Locations

US (1)