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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01163448
Recruitment Status : Withdrawn (Lack of accrual)
First Posted : July 15, 2010
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP. [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163448


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: James Eastham, MD Memorial Sloan Kettering Cancer Center
More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01163448     History of Changes
Other Study ID Numbers: 09-013
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
Prostate
Radiation
Radical prostatectomy
09-013