Clinical trial NCT01856855: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Radiation Toxicity
Sexual Dysfunction
Keywords: Prostate Cancer
Prostate Adenocarcinoma
Radiation
SBRT
Stereotactic Body Radiation Therapy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 26
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer
timeFrame: Within 3 months of the completion of radiation therapy
Secondary outcomes:
measure: Treatment Planning Feasibility
timeFrame: Within 6 months of completion of radiation therapy
measure: Early Efficacy
timeFrame: Within 6 months of completion of radiation therapy
measure: Number of Patients Who Experienced Late Toxicity
timeFrame: Within 6 months of completion of radiation therapy
measure: Median Quality of Life Score
timeFrame: Within 6 months of completion of radiation therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Hazelrig-Salter Radiation Oncology Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham Radiation Oncology
name: John B Fiveash, MD
role: PRINCIPAL_INVESTIGATOR
References: