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

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ClinicalTrials.gov Identifier: NCT01856855
Recruitment Status : Active, not recruiting
First Posted : May 17, 2013
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
John Fiveash, MD, University of Alabama at Birmingham

April 10, 2013
May 17, 2013
March 23, 2018
February 2013
February 2020   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01856855 on ClinicalTrials.gov Archive Site
  • 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:
    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.
  • 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.
  • Treatment planning dosimetric goals met for target coverage and normal tissue constraints [ Time Frame: Within 6 months of completion of radiation therapy ]
    Dosimetric goals will be evaluated via dose volume histogram analysis and scored on ability on meet pre-set radiation dose target coverage (treating all targets with adequate dose) and normal tissue constraints (limiting radiation to normal surrounding structures)
  • Treatment delivery quality assurance [ Time Frame: Within 2 years of completion of radiation therapy ]
    All radiation plans will be validated with physicists measuring linear accellarator 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 determined based upon clinical exams and lab values (PSA) done at regular intervals
  • 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.
Not Provided
Not Provided
 
Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)
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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Radiation Toxicity
  • Sexual Dysfunction
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
Experimental: Stereotactic Body Radiation Therapy with Integrated Boost
Intervention: Radiation: Stereotactic Body Radiation Therapy with Integrated Boost
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
Same as current
February 2021
February 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
19 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01856855
F121218006
Yes
Not Provided
Not Provided
John Fiveash, MD, University of Alabama at Birmingham
John Fiveash, MD
Not Provided
Principal Investigator: John B Fiveash, MD University of Alabama at Birmingham Radiation Oncology
University of Alabama at Birmingham
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP