Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Stereotactic Body Radiation Therapy

Nicholas Nickols, MD, PhD

This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.

PRIMARY OBJECTIVES:

I. To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate cancer patients at high risk for recurrence after prostatectomy.

SECONDARY OBJECTIVES:

I. To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported quality of life (Expanded Prostate Cancer Index Composite \[EPIC\] and International Prostate Symptom Score \[IPSS\] questionnaires).

II. Investigation of the radiobiology of SBRT in prostate cancer using resected prostate tumor tissue.

III. Evaluation of the nature of the immune response to prostate cancer generated by SBRT.

OUTLINE:

Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

After completion of the study treatment, patients are followed up at 0 to 4 weeks, and every 3 months for 1 year.

Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery

Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy

Based on the Common Terminology Criteria for Adverse Events (CTCAE) v4. Grade refers to the severity of the adverse event. Indications are Grade 1 is Mild, Grade 2 is Moderate, Grade 3 is Severe or medically significant but not immediately life threatening. Grade 0 refers to absence of an adverse event (ae).

The Expanded Prostate Cancer Index Composite Short Form (EPIC-26) is composed of 26 items and measures health-related quality of life across 5 prostate cancer domains. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing a better quality of life.

The International Prostate Symptom Score is composed of seven questions and scored from 0 - 35, with higher scores indicating more severe symptoms.

Tissue specimens of the primary tumor as well as blood draws before and after treatment will be used to conduct biomarker and molecular analyses relevant to understanding the biology of prostate SBRT

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Stereotactic Body Radiation Therapy (SBRT)

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Gleason grade assigned based on predominant pattern in biopsy + a second Gleason grade to the second most predominate pattern. The two grades are added together to determine the Gleason score. Assigned Gleason scores range from 6 - 10, with 6 being low grade or better and 10 is high grade or worse.

Gleason Grade

Primary tumor, regional nodes, metastasis (TNM) staging system: A system to describe the amount and spread of cancer in a patient's body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). Larger numbers indicate worse indication.

CStage

Nicholas Nickols, MD

Treatment Stereotactic Body Radiotherapy (SBRT)

Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications

Genitourinary Toxicities

Gastrointestinal toxicities

Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities

Urinary Incontinence

urinary irritative/obstructive

Bowel

Sexual Function

Hormonal

Change in score from baseline at 12 months. Quality-of-Life Assessment: Ancillary studies

Mean change in EPIC-26 score from baseline to 12 months. Three patients dd not complete the QOL assessment and therefore were not included in the analysis.

Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.

Three patients dd not complete the QOL assessment and therefore were not included in the analysis.

Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.

CD11b

CD68

CD163

Post SBRT and Radical Prostatectomy (RP)

Pre-treatment biopsies and surgical specimens from this trial were used to determine radiation-induced changes in macrophage subsets. Six participants had available paired biopsy cores and Radical Prostatectomy (RP) specimens for analysis.

Correlative Biomarker Analyses Using Tissue and Serial Blood Samples

CD3+CD8

CD3+CD4

CD4+FOXp3

Pre-treatment biopsies and surgical specimens from this trial were used to determine radiation-induced changes in T cell. Six participants had available paired biopsy cores and RP specimens for analysis.

Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

Spots Global Cancer Trial Database for stage i prostate adenocarcinoma american joint committee on cancer (ajcc) v7