Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer

Phase 1

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Radiation: High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy

• Registration Number: NCT01163448
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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/or bad, the radiation will have on men undergoing prostatectomy. The investigators are especially interested in men who are at risk for having cancer cells that have spread outside the prostate.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High-Dose Single-Fraction Image-Guided Radiotherapy	High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy	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.

Primary Outcome Measures

Name	Time	Method
To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT).	1 year	Given prior to radical prostatectomy (RP) in men at high risk for extraprostatic cancer.

Secondary Outcome Measures

Name	Time	Method
To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP.	1 year
To assess the long-term toxicity of intensity modulated radiotherapy (IG-IMRT)	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 analyze the changes in prostate perfusion induced by single-fraction IG-IMRT.	1 before radiation simulation, 1 after radiation treatment	via dynamic contrast enhanced magnetic resonance imaging (DCE-MRI)

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States