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A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day


Phase 2
40 Years
82 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day


This protocol requires radiation treatments to be performed with a stereotactic technique
with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or
use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.


Inclusion Criteria:



- Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days
of study enrollment

- History/physical examination with digital rectal examination of the prostate within 8
weeks prior to study enrollment

- Gleason score less than or equal to 7

- Clinical Stage T1-T2c

- PSA

- less than or = 15 ng/ml prior to start of therapy if Gleason < or = 6 or

- less than or = 10 ng/ml prior to start of therapy if Gleason = 7

- Zubrod Performance Status 0-1

- Age > 40

Exclusion Criteria:

- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or
lymphomatous/hematogenous malignancy unless continually disease free for a minimum of
5 years. (Carcinoma in situ of the bladder or oral cavity is permissible)

- Evidence of distant metastases

- Regional lymph node involvement

- Significant urinary obstruction

- Estimated prostate gland > 100 grams

- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

- Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide),
anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical
castration (bilateral orchiectomy) or planned concurrent androgen deprivation therapy

- Previous or concurrent cytotoxic chemotherapy for prostate cancer

- Prosthetic implants in the pelvic region that contain metal or conductive materials
(e.g., an artificial hip).

- Severe, active comorbidity

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

William R Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00018266

NCT ID:

NCT00941915

Start Date:

November 2009

Completion Date:

December 2015

Related Keywords:

  • Prostate Cancer
  • CaP
  • SBRT
  • Prostate
  • ExacTrac
  • Calypso
  • IMRT
  • Radiation
  • Cancer of Prostate
  • Prostatic Neoplasms
  • Prostatic Neoplasms

Name

Location

Duke University Medical CenterDurham, North Carolina  27710