Stereotactic Body Radiotherapy for Prostate Cancer

Mercy Research

Status: Completed

Conditions: Prostate Cancer

Treatments: Radiation: stereotactic body radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01352598

11-022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

Stereotactic Body Radiotherapy

Other group

Description:

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.

Treatment:

Radiation: stereotactic body radiotherapy