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

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, Radiation, Radical prostatectomy, 09-013

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High-Dose Single-Fraction Image-Guided Radiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT.
via dynamic contrast enhanced magnetic resonance imaging (DCE-MRI)
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.
To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP.

Full Information

First Posted
July 14, 2010
Last Updated
March 4, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01163448
Brief Title
Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of accrual
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, Radiation, Radical prostatectomy, 09-013

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-Dose Single-Fraction Image-Guided Radiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT).
Description
Given prior to radical prostatectomy (RP) in men at high risk for extraprostatic cancer.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT.
Description
via dynamic contrast enhanced magnetic resonance imaging (DCE-MRI)
Time Frame
1 before radiation simulation, 1 after radiation treatment
Title
To assess the long-term toxicity of intensity modulated radiotherapy (IG-IMRT)
Description
Given prior to radical prostatectomy (RP) with respect to urinary function, erectile function, and bowel function.
Time Frame
weeks 3, 6, 9, 12, 18, 24, 30, and 36 months after RP
Title
To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP.
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Eastham, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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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