Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)

NCT ID: NCT01856855

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2022-12-31

Brief Summary

This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the entire prostate. The investigators have hypothesized that this treatment technique will effectively control the prostate cancer while minimizing the side effects.

Detailed Description

Objectives:

Primary

-Clinically assess the early toxicity of SBRT with integrated boost for clinically localized prostate cancer

Secondary

• Determine the technical feasibility of stereotactic body radiotherapy (SBRT) with integrated boost for clinically localized prostate cancer

• Determine the treatment planning and dosimetric feasibility
• Evaluate the treatment delivery quality assurance
• Clinically assess early efficacy, late toxicity, and quality of life for patients receiving SBRT with integrated boost for clinically localized prostate cancer

Patients will undergo 5 total radiation treatments over 7-17 day period.

Patients will be asked to complete American Urological Association Symptom Index (AUA SI), Sexual Health Inventory of Men (SHIM), and the Expanded Prostate Index Composite (EPIC)questionnaires. The EPIC assesses bowel, urinary, and sexual function. These questionnaires will be completed at the following time points: Baseline, AUA SI will be collected on the last day of treatment, and every 3 months for the first year following the start of radiation, then every 6 months for year 2.

After completion of study therapy, patients are followed-up every 3 months for the first year, then every 6 months for year 2.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Radiation Toxicity; Sexual Dysfunction

Study Design

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

Study Groups

Stereotactic Body Radiation Therapy with Integrated Boost

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy with Integrated Boost

Intervention Type: RADIATION

SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions

Interventions

Stereotactic Body Radiation Therapy with Integrated Boost

SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions

Intervention Type: RADIATION

Other Intervention Names

SBRT; IMRT; VMAT

Eligibility Criteria

Inclusion Criteria

• All patients must have Histologically confirmed prostate adenocarcinoma, with biopsies obtained within twelve months of patient registration
• NCCN risk category very low, low, or intermediate risk
• Combined Gleason score <7
• PSA within three months of enrollment < 20ng/ml
• Clinical stage T1a-c N0M0 or clinical stage T2aN0M0
• Life expectancy > 5 years
• Risk of malignant lymph node involvement < 15% as calculated on Partin tables
• Karnofsky performance status (KPS) > 60
• Age > 19 years
• Subjects given written informed consent

Exclusion Criteria

• History of inflammatory bowel disease
• Prior radical prostate surgery, transurethral resection of the prostate(TURP), or prostate cryotherapy
• Platelet count < 70
• Pre-SBRT prostate volume > 120 cc as estimated by trans-rectal ultrasound at time of prostate biopsy (TRUS biopsy).
• Risk of malignant lymph node involvement > 15% as calculated on Partin tables.

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

John Fiveash, MD

OTHER

Sponsor Role: lead

Responsible Party

John Fiveash, MD

Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John B Fiveash, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham Radiation Oncology

Locations

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

F121218006

Identifier Type: -

Identifier Source: org_study_id