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 has been terminated.
(Lack of accrual)
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01163448
First received: July 14, 2010
Last updated: August 24, 2011
Last verified: August 2011
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 1 before radiation simulation, 1 after radiation treatment ] [ Designated as safety issue: No ]
    via dynamic contrast enhanced magnetic resonance imaging (DCE-MRI)

  • 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 ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01163448     History of Changes
Other Study ID Numbers: 09-013
Study First Received: July 14, 2010
Last Updated: August 24, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014