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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: Completed NA study of Prostate Adenocarcinoma, sponsored by Wake Forest University Health Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Phoenix definition: Biochemical recurrence of prostate cancer (PCa) after curative radiotherapy defined as a prostate-specific antigen (PSA) rise of ≥2 ng/ml above the nadir. Astro definition: Biochemical failure in prostate cancer defined as three consecutive rises in prostate-specific antigen (PSA) after a nadir.
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 |
What the finished NCT01985828 record still lists
NCT01985828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (62% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01985828's enrollment target sits among peer trials
83 48th of 99 higher than 52 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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