Stereotactic Body Radiotherapy for Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: stereotactic body radiotherapy

• Registration Number: NCT01352598
• Lead Sponsor: Mercy Research

Brief Summary

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-12
• Study Start: 2011-06
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Results First Submitted: 2020-07-29
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Results First Posted: 2020-09-23
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 84

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Body Radiotherapy	stereotactic body radiotherapy	Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.

Primary Outcome Measures

Name	Time	Method
Biochemical Control Rate	one year	Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression.

Secondary Outcome Measures

Name	Time	Method
Late Toxicity Rate	one year	Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment.

Trial Locations

Locations (1)

Mercy Hospital St. Louis; 🇺🇸 Saint Louis, Missouri, United States