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CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer
NCT01985828 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,061 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01985828 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01985828?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,061 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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