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Stereotactic Body Radiotherapy for Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

stereotactic body radiotherapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, stereotactic radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Mercy Hospital St. Louis

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Stereotactic Body Radiotherapy

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Late Toxicity Rate

Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment.

Full Information

NCT ID

NCT01352598

First Posted

May 10, 2011

Last Updated

September 2, 2020

Sponsor

Mercy Research

1. Study Identification

Unique Protocol Identification Number

NCT01352598

Brief Title

Stereotactic Body Radiotherapy for Prostate Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

April 2019 (Actual)

Study Completion Date

April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mercy Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostate cancer, stereotactic radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stereotactic Body Radiotherapy

Arm Type

Other

Arm 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.

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiotherapy

Intervention 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.

Primary Outcome Measure Information:

Title

Biochemical Control Rate

Description

Time Frame

one year

Secondary Outcome Measure Information:

Title

Late Toxicity Rate

Description

Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment.

Time Frame

one year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Mercy Hospital St. Louis

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

12. IPD Sharing Statement

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