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 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

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.

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT.	via dynamic contrast enhanced magnetic resonance imaging (DCE-MRI)	1 before radiation simulation, 1 after radiation treatment
To assess the long-term toxicity of intensity modulated radiotherapy (IG-IMRT)	Given prior to radical prostatectomy (RP) with respect to urinary function, erectile function, and bowel function.	weeks 3, 6, 9, 12, 18, 24, 30, and 36 months after RP
To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP.		1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: July 14, 2010
• First Submitted That Met QC Criteria: July 14, 2010
• First Posted (Estimate): July 15, 2010

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Radical prostatectomy; Prostate; Radiation; 09-013
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 09-013