Stereotactic Body Radiotherapy for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352598
• Other study ID #: 11-022
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: April 2019

Study information

• Verified date: September 2020
• Source: Mercy Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
United States	Mercy Hospital St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical Control Rate	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.	one year
Secondary	Late Toxicity Rate	Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment.	one year