Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer
|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Recruitment Status : Withdrawn (Lack of accrual)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 ]
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|