Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT).

Outcome Description:

Given prior to radical prostatectomy (RP) in men at high risk for extraprostatic cancer.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

James Eastham, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

09-013

NCT ID:

NCT01163448

Start Date:

July 2010

Completion Date:

July 2012

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Radiation
  • Radical prostatectomy
  • 09-013
  • Prostatic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021