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

Primary Purpose

Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy with Integrated Boost
Sponsored by
John Fiveash, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Prostate Adenocarcinoma, Radiation, SBRT, Stereotactic Body Radiation Therapy

Eligibility Criteria

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

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.

Sites / Locations

  • Hazelrig-Salter Radiation Oncology Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Body Radiation Therapy with Integrated Boost

Arm Description

Outcomes

Primary Outcome Measures

Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer
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.

Secondary Outcome Measures

Treatment Planning Feasibility
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.
Early Efficacy
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: No prostate cancer recurrence evident on the physical examination performed by the physician. 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.
Number of Patients Who Experienced Late Toxicity
Late toxicity (defined as toxicity occuring >90 days after treatment) will be assessed with regular clinical exams and patient toxicity questionnaires.
Median Quality of Life Score
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)).

Full Information

First Posted
April 10, 2013
Last Updated
December 19, 2022
Sponsor
John Fiveash, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01856855
Brief Title
Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)
Official Title
RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Fiveash, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity, Sexual Dysfunction
Keywords
Prostate Cancer, Prostate Adenocarcinoma, Radiation, SBRT, Stereotactic Body Radiation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Body Radiation Therapy with Integrated Boost
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy with Integrated Boost
Other Intervention Name(s)
SBRT, IMRT, VMAT
Intervention Description
SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions
Primary Outcome Measure Information:
Title
Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer
Description
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.
Time Frame
Within 3 months of the completion of radiation therapy
Secondary Outcome Measure Information:
Title
Treatment Planning Feasibility
Description
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.
Time Frame
Within 6 months of completion of radiation therapy
Title
Early Efficacy
Description
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: No prostate cancer recurrence evident on the physical examination performed by the physician. 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.
Time Frame
Within 6 months of completion of radiation therapy
Title
Number of Patients Who Experienced Late Toxicity
Description
Late toxicity (defined as toxicity occuring >90 days after treatment) will be assessed with regular clinical exams and patient toxicity questionnaires.
Time Frame
Within 6 months of completion of radiation therapy
Title
Median Quality of Life Score
Description
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)).
Time Frame
Within 6 months of completion of radiation therapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John B Fiveash, MD
Organizational Affiliation
University of Alabama at Birmingham Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hazelrig-Salter Radiation Oncology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States

12. IPD Sharing Statement

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

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