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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01163448
• Other study ID #: 09-013
• Status: Withdrawn
• Phase: Phase 1
• First received: July 14, 2010
• Last updated: March 4, 2015
• Start date: July 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	Yes
Secondary	To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT.	via dynamic contrast enhanced magnetic resonance imaging (DCE-MRI)	1 before radiation simulation, 1 after radiation treatment	No
Secondary	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.	weeks 3, 6, 9, 12, 18, 24, 30, and 36 months after RP	Yes
Secondary	To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP.		1 year	No

External Links

•   Memorial Sloan Kettering Cancer Center