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NCT01985828 · ClinicalTrials.gov registry record · NA
CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer
A NA study of Prostate Adenocarcinoma, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 83
- Enrollment target
- 1
- Study location
NCT01985828 is a NA study of Prostate Adenocarcinoma that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 83 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01985828, a NA study of Prostate Adenocarcinoma, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 83 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- RADIATION CyberKnife
- OTHER Androgen Deprivation Therapy (ADT)
- RADIATION Intensity Modulated radiation therapy (IMRT)
Study Locations (1)
Illinois
- Advocate Lutheran General Hospital - Park Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2013-11-19 |
| Est. Completion | 2019-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01985828
The ClinicalTrials.gov registry entry for NCT01985828 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (62% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which CyberKnife is the first listed.
NCT01985828 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT01985828 about?
NCT01985828 is a clinical study titled "CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer". 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 Rad...
What is the current status of trial NCT01985828?
This trial is currently completed. It is a NA study. The enrollment target is 83 participants. The study started on 2013-11-19. Estimated completion is 2019-08.
What conditions does trial NCT01985828 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma.
What interventions are being tested in trial NCT01985828?
The interventions under investigation include: CyberKnife (RADIATION), Androgen Deprivation Therapy (ADT) (OTHER), Intensity Modulated radiation therapy (IMRT) (RADIATION).
Who is sponsoring clinical trial NCT01985828?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01985828 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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