Status:
WITHDRAWN
Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This study is being done to test the safety of a single high-dose of radiation therapy before radical prostatectomy (removal of the prostate). The investigators want to find out what effects, good and...
Eligibility Criteria
Inclusion
- Biopsy-proven prostate cancer verified at MSKCC. The biopsy will include a minimum of 10 cores
- Radical Prostatectomy (RP) chosen as the therapeutic method
- The size of the prostate will be \< 70 cc by transrectal ultrasound or endorectal MRI imaging
- No radiographic evidence of lymph node metastases, bone metastases or soft tissue disease
- Risk of extraprostatic cancer of \> 40% based on the MSKCC surgical nomogram
- Age \> or = to 18 years
- KPS \> or = to 80
- Able to tolerate immobilization cradle positioning
Exclusion
- Allergic reaction to intravenous CT contrast (if premedicated, pt will not be excluded)
- Prior radiation to the planned target region
- Patients receiving concurrent chemotherapy
- Neoadjuvant hormonal therapy Luteinizing-hormone-releasing hormone(LHRH)agonist and/or antiandrogen)
- Prior transurethral resection of the prostate
- Normal tissue directly overlying target precluding ability to limit the bowel, bladder, rectum or other tissue to less than or equal to 15-16 Gy dose constraints
- Dominant prostatic lesion within 3 mm from the anterior rectal wall by imaging studies
- Creatinine clearance \<60 ml/min/1.73m2
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01163448
Start Date
July 1 2010
End Date
August 1 2011
Last Update
March 6 2015
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065