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

Not Applicable

Completed

Conditions: Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7
Stage II Prostate Adenocarcinoma AJCC v7
Stage III Prostate Adenocarcinoma AJCC v7

Interventions: Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Radiation: Stereotactic Body Radiation Therapy

Registration Number: NCT02830165

Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 11

Inclusion Criteria

Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
Patient desires and is medically fit to undergo prostatectomy
Karnofsky performance status (KPS) >= 70
Patients on androgen deprivation therapy (ADT) are allowed
For confirmation of high risk local failure status, patients will have any one of the following:
- Computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating seminal vesicle invasion (SVI) or extraprostatic extension (EPE) within 1 year of enrollment into the study
- Pre-biopsy prostate-specific antigen (PSA) >= 20
- Gleason score 7-10 (Gleason 7 must be 4+3), presence of any Gleason 5 (even if a tertiary score) as determined at diagnostic biopsy
- Gleason score 7 and > 50% of biopsy cores positive for prostate cancer
- Clinical stage >= T3 (staging by imaging acceptable)
An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is encouraged but not required if not performed as standard of care biopsy

Exclusion Criteria

Distant metastases, based upon:
- CT scan or MRI of the abdomen/pelvis or prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) within 120 days prior to registration and
- Bone scan or PSMA PET/CT within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis prior to registration
Patient is unable or unwilling to sign consent
Patient is considered low-risk and would not have received adjuvant radiation therapy (RT) outside of this study

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (SBRT)	Quality-of-Life Assessment	Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
Treatment (SBRT)	Stereotactic Body Radiation Therapy	Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
Treatment (SBRT)	Laboratory Biomarker Analysis	Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications	At 4 weeks post surgery

Secondary Outcome Measures

Name	Time	Method
Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.	score from baseline to twelve months	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.
Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.	Mean change in I-PSS score from baseline to 12 months.	The International Prostate Symptom Score is composed of seven questions and scored from 0 - 35, with higher scores indicating more severe symptoms.
Correlative Biomarker Analyses Using Tissue and Serial Blood Samples	Baseline and to up to 1 year	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
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities	Up to 1 year	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).