RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer
19 Years
N/A
Male
Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity, Sexual Dysfunction
Trial Information
RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Early toxicity of SBRT with Integrated Boost for localized prostate cancer
Outcome 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.
Outcome Time Frame:
Within 3 months of the completion of radiation therapy
Safety Issue:
Yes
Principal Investigator
John B Fiveash, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Alabama at Birmingham Radiation Oncology
Authority:
United States: Institutional Review Board
Study ID:
F121218006
NCT ID:
NCT01856855
Start Date:
February 2013
Completion Date:
Related Keywords:
- Prostate Cancer
- Prostate Adenocarcinoma
- Radiation Toxicity
- Sexual Dysfunction
- Prostate Cancer
- Prostate Adenocarcinoma
- Radiation
- SBRT
- Stereotactic Body Radiation Therapy
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms
- Sexual Dysfunctions, Psychological
- Radiation Injuries
Name | Location |
|---|---|
| Hazelrig-Salter Radiation Oncology Center | Birmingham, Alabama 35249 |
