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

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:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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.

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

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:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

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 Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 13, 2013