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Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer


Phase 4
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer


This is a single site, non-randomized, prospective, phase IV trial of patients with
organ-confined prostate cancer. Data collected will include patient demographics, pathology
data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal
tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be
collected during the patient's standard office visits. The anticipated duration of this
study is 5 years.


Inclusion Criteria:



- Patient age >= 18 years

- Zubrod performance status of 0-3

- T1-3 N0 M0 adenocarcinoma of the prostate

- Prostate volume ≤ 100 cc

- Signed study-specific consent form

Exclusion Criteria

- Extension of local tumor to involve adjacent organs other than seminal vesicles (T4)

- Prostate volume > 100 cc

- Nodal involvement

- Metastatic disease

- Prior pelvic radiotherapy except as part of combination therapy for prostate cancer

- History of scleroderma

- Patients with psychiatric or addictive disorder that would preclude obtaining
informed consent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Biochemical control rate

Outcome Description:

Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals.The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used.

Outcome Time Frame:

one year

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

11-022

NCT ID:

NCT01352598

Start Date:

June 2011

Completion Date:

June 2018

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • stereotactic radiotherapy
  • Prostatic Neoplasms

Name

Location

Mercy Hospital St. Louis St. Louis, Missouri  63141