NCT01985828

CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer

Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to document the effectiveness of Cyberknife stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years. During the prostate-specific antigen era, an ever-increasing percentage of men with prostate cancer have presented with clinically localized, potentially curable disease. Although conventional treatment options are potentially curative in selected patients, these treatments also have drawbacks, including the risk of negative long-term quality of life consequences and serious complications. The CyberKnife® system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL questionnaires before treatment. Questionnaires will also be completed during follow-up visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.

Detailed description

The purpose of this project is to evaluate the efficacy and Health-Related Quality of Life (HRQOL) in intermediate and high-risk prostate cancer patients treated with SBRT as monotherapy or as a boost in combination with IMRT.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	CyberKnife
OTHER	Androgen Deprivation Therapy (ADT)
RADIATION	Intensity Modulated radiation therapy (IMRT)	Per current standard of care

Timeline

• Start date: 2013-11-19
• Primary completion: 2018-09-01
• Completion: 2019-08-01
• First posted: 2013-11-15
• Last updated: 2024-10-03
• Results posted: 2024-10-01

Locations

1 site across 1 country: United States