Boston Medical Center
Boston, Massachusetts, 02118, United States
NCT Number: NCT01508390
In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Male
Interventional
Not applicable
Boston, Massachusetts, 02118, United States
In this study, participants will have standard androgen deprivation therapy and undergo standard radiation therapy to the prostate and at-risk lymph nodes by intensity-modulated radiation therapy (IMRT). The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
a. T-stage determined by physical exam (Digital Rectal Exam Required)
i. MRI findings (e.g. extracapsular extension) can be used to determine T-staging
b. N-stage determined using abdominopelvic CT scan and/or MRI
c. M-stage determined by physical exam, CT and/or MRI, and bone scan (must be M0, excepting Lymph nodes)
Please note: a SPECT bone scan including a CT of the abdomen and pelvis or an F18 Fluciclovine PET/CT fulfills protocol criteria for both the abdominopelvic CT and bone scan.
OR
Exclusion criteria
21 Gy in 7 Gy per day, 3 fractions, Every other day
Other names: stereotactic radiotherapy, cyberknife, radiation
Time frame: 5 years
To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions
Time frame: 5 years
Rate of local failure
Time frame: 5 years
Rate of distant failure
Time frame: 5 years
disease-free survival
Time frame: 5 years
Rate of disease-specific survival
Time frame: 5 years
Rate of overall survival
Time frame: 5 years
rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity following combination androgen deprivation therapy, External Beam Radiation Therapy and CyberKnife radiosurgery as a boost
Boston Medical Center
Other
Phase II Study of Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate for Treatment of Localized, Non-Metastatic, High Risk Prostate Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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