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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
John Fiveash, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01856855
First received: April 10, 2013
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Prostate Cancer
Prostate Adenocarcinoma
Radiation Toxicity
Sexual Dysfunction
Radiation: Stereotactic Body Radiation Therapy with Integrated Boost

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Early toxicity of SBRT with Integrated Boost for localized prostate cancer [ Time Frame: Within 3 months of the completion of radiation therapy ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Within 6 months of completion of radiation therapy ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Late quality of life will be assessed with regular clinical exams and patient quality of life questionnaires.


Estimated Enrollment: 25
Study Start Date: February 2013
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856855

Locations
United States, Alabama
Hazelrig-Salter Radiation Oncology Center Recruiting
Birmingham, Alabama, United States, 35249
Contact: Anna Messer, RN, OCN, MSN    205-975-2880    amesser@uabmc.edu   
Contact: Kristin Webb, BA    205-975-9316    kkwebb@uabmc.edu   
Principal Investigator: John Fiveash, MD         
Sub-Investigator: Grant Clark, MD         
Sub-Investigator: Michael C Dobelbower, MD, PhD         
Sub-Investigator: Rojymon Jacob, MD         
Sub-Investigator: Robert Kim, MD         
Sub-Investigator: Eddy Yang, MD, PhD         
Sub-Investigator: Omer Lee Burnett, MD         
Sub-Investigator: Peter Kolettis, MD         
Sub-Investigator: Richard Popple, PhD         
Sub-Investigator: Rex Cardan, PhD         
Sponsors and Collaborators
John Fiveash, MD
Investigators
Principal Investigator: John B Fiveash, MD University of Alabama at Birmingham Radiation Oncology
  More Information

No publications provided

Responsible Party: John Fiveash, MD, Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01856855     History of Changes
Other Study ID Numbers: F121218006
Study First Received: April 10, 2013
Last Updated: December 31, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
Prostate Cancer
Prostate Adenocarcinoma
Radiation
SBRT
Stereotactic Body Radiation Therapy

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014