Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01856855|
Recruitment Status : Active, not recruiting
First Posted : May 17, 2013
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Adenocarcinoma Radiation Toxicity Sexual Dysfunction||Radiation: Stereotactic Body Radiation Therapy with Integrated Boost||Not Applicable|
-Clinically assess the early toxicity of SBRT with integrated boost for clinically localized prostate cancer
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 (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2021|
|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
- 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.
- 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.
- Treatment delivery quality assurance [ Time Frame: Within 2 years of completion of radiation therapy ]All radiation plans will be validated with physicists measuring linear accelerator dose output utilizing a combination of a solid water phantom or a dose calibrated diode array. The phantom will be irradiated with the same plan as the patient including all couch angles and beam projections and will be assessed as to whether the plan meets a pre-specified validation value
- 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:
- 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.
- 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.
- Late Quality of Life [ Time Frame: Within 6 months of completion of radiation therapy ]Late quality of life will be assessed with regular clinical exams and patient quality of life questionnaires.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856855
|United States, Alabama|
|Hazelrig-Salter Radiation Oncology Center|
|Birmingham, Alabama, United States, 35249|
|Principal Investigator:||John B Fiveash, MD||University of Alabama at Birmingham Radiation Oncology|