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

December 19, 2022 updated by: John Fiveash, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Hazelrig-Salter Radiation Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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
  • Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids are not considered an exclusion criteria.
  • Platelet count < 70
  • Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stereotactic Body Radiation Therapy with Integrated Boost
Radiation: Stereotactic Body Radiation Therapy with Integrated Boost
SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions
Other Names:
  • SBRT
  • IMRT
  • VMAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer
Time Frame: Within 3 months of the completion of radiation therapy
Early toxicity (defined as events occurring within 90 days of therapy) will be assessed by physician history and physical exams and patient toxicity/quality-of-life questionnaires to be administered at regular intervals.
Within 3 months of the completion of radiation therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Planning Feasibility
Time Frame: Within 6 months of completion of radiation therapy

Feasibility will be defined as the ability of the treatment planner to create a plan that meets the following criteria:

  • 100% of radiation target prescription (36.25 Gy) covers greater than or equal to 95% of the target (prostate)
  • At least 95% of the boost prostate (area within the prostate most likely harboring cancer) prescription (38.0 Gy) covers 95% of this boost target volume
  • All normal tissue dose constraints are met -i.e., nearby rectum, bladder, and femoral heads do not exceed the recommended radiation dose limits

If the physician must utilize a plan that compromises target coverage or normal tissue dose constraints to levels not meeting the criteria above, then the plan will be scored as not meeting technical feasibility requirements.
Within 6 months of completion of radiation therapy
Early Efficacy
Time Frame: Within 6 months of completion of radiation therapy

Efficacy will be defined as the absence of biochemically detected (via PSA lab testing) prostate cancer or clinically detected prostate cancer at each interval follow-up visit (every three months for year one, then every 6 months for year two after treatment). "Absence of prostate cancer" is defined as no evidence of tumor recurrence by two methods:

  1. No prostate cancer recurrence evident on the physical examination performed by the physician.
  2. No rise in the PSA more than 2 ng/ml above the lowest PSA value ever obtained pre or post treatment. A rise in the PSA more than 2 ng/ml from a patient's lowest value is the standard definition for post-radiation PSA biochemical prostate cancer failure.
Within 6 months of completion of radiation therapy
Number of Patients Who Experienced Late Toxicity
Time Frame: Within 6 months of completion of radiation therapy
Late toxicity (defined as toxicity occuring >90 days after treatment) will be assessed with regular clinical exams and patient toxicity questionnaires.
Within 6 months of completion of radiation therapy
Median Quality of Life Score
Time Frame: Within 6 months of completion of radiation therapy
Median of quality of life score will be assessed with regular clinical exams and patient quality of life questionnaires (American Urologic Association Symptom Index score ranges from 0 to 35 with the higher scores indicating more severe, Sexual Health Inventory score ranges from 1 to 25 with 1 being severe and 25 being no signs, Extended Prostate Cancer Index Composite- Bowel, Extended Prostate Cancer Index Composite- Urinary, and Extended Prostate Cancer Index Composite- Sexual scales range from 1 (worst) to 100 (best)).
Within 6 months of completion of radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Fiveash, MD

Investigators

  • Principal Investigator: John B Fiveash, MD, University of Alabama at Birmingham Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (Estimate)

May 17, 2013

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F121218006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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