Stereotactic Body Radiotherapy for Prostate Cancer

NCT ID: NCT01352598

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2019-04-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

stereotactic body radiotherapy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mercy Research

OTHER

Sponsor Role: lead

Responsible Party

Jaymeson Stroud, MD

Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mercy Hospital St. Louis

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

11-022

Identifier Type: -

Identifier Source: org_study_id