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

Stage III Prostate Adenocarcinoma AJCC v7 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830165
• Other study ID #: 15-001580
• Secondary ID: NCI-2016-00188JC
• Status: Completed
• Phase: N/A
• Start date: June 15, 2016
• Est. completion date: May 27, 2022

Study information

• Verified date: May 2022
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 27, 2022
• Est. primary completion date: May 9, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostatic Neoplasms
• Stage II Prostate Adenocarcinoma AJCC v7
• Stage III Prostate Adenocarcinoma AJCC v7

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies

Radiation:
• Stereotactic Body Radiation Therapy
Undergo SBRT

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications		At 4 weeks post surgery
Secondary	Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities	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).	Up to 1 year
Secondary	Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.	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.	score from baseline to twelve months
Secondary	Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.	The International Prostate Symptom Score is composed of seven questions and scored from 0 - 35, with higher scores indicating more severe symptoms.	Mean change in I-PSS score from baseline to 12 months.
Secondary	Correlative Biomarker Analyses Using Tissue and Serial Blood Samples	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	Baseline and to up to 1 year