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

NCT ID: NCT01163448

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-08-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Eastham, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

09-013

Identifier Type: -

Identifier Source: org_study_id