Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer
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|ClinicalTrials.gov Identifier: NCT01163448|
Recruitment Status : Withdrawn (Lack of accrual)
First Posted : July 15, 2010
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Experimental: High-Dose Single-Fraction Image-Guided Radiotherapy
This will assess the feasibility and safety of this approach in men at high-risk for extraprostatic prostate cancer undergoing RP. This initial trial has been designed in a manner intended to emphasize patient comfort and safety.
Radiation: High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy
A baseline DCE-MRI will be obtained prior to the day of radiotherapy treatment. Immediately following the delivery of radiotherapy another DCE-MRI will be performed to assess for perfusion changes in the prostate resulting from irradiation. RP will be completed within 6 weeks (+ 2 weeks) of radiation and the RP specimen will be assessed for radiation treatment effect and other pathologic parameters (including surgical margin status) by a dedicated genitourinary pathologist. Following RP, participants will follow-up with their surgeon every 3 months for one year, with visits alternating between the urologist and the radiation oncologist. After the first year follow-up will occur at 6 month intervals until the patient is 3 years out from surgery.
- To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT). [ Time Frame: 1 year ]Given prior to radical prostatectomy (RP) in men at high risk for extraprostatic cancer.
- To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT. [ Time Frame: 1 before radiation simulation, 1 after radiation treatment ]via dynamic contrast enhanced magnetic resonance imaging (DCE-MRI)
- To assess the long-term toxicity of intensity modulated radiotherapy (IG-IMRT) [ Time Frame: weeks 3, 6, 9, 12, 18, 24, 30, and 36 months after RP ]Given prior to radical prostatectomy (RP) with respect to urinary function, erectile function, and bowel function.
- To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163448
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||James Eastham, MD||Memorial Sloan Kettering Cancer Center|