NCT01163448

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

July 14, 2010

Last Update Submit

March 4, 2015

Conditions

Prostate Cancer

Keywords

ProstateRadiationRadical prostatectomy09-013

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT.

    1 before radiation simulation, 1 after radiation treatment

  • To assess the long-term toxicity of intensity modulated radiotherapy (IG-IMRT)

    weeks 3, 6, 9, 12, 18, 24, 30, and 36 months after RP

  • To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP.

    1 year

Study Arms (1)

High-Dose Single-Fraction Image-Guided Radiotherapy

EXPERIMENTAL

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

Interventions

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

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.

High-Dose Single-Fraction Image-Guided Radiotherapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • James Eastham, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 15, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

US(1)