Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

NCT03889119 | Active Not Recruiting FDA Device

• 1 other identifier: 115-16-CA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn the long term efficacy and side effects associated with utilizing Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. SBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. The Elekta Versa and Agility Systems are approved by the Food and Drug Association (FDA) for SBRT treatment of cancer. Traditional External beam radiation therapy (EBRT) for prostate carcinoma is typically done over the course of approximately 42-45 daily treatments SBRT is a way to condense this treatment into a course of 5 treatments, delivering more dose per day.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The primary aim of this study is to examine biochemical failure rates after SBRT for patients with low, intermediate, and high risk localized non-metastatic prostate cancer.

  The number of patients demonstrating biochemical failure will be assessed. Biochemical failure will be defined using the Phoenix definition (Roach et al. IJROBP 2006), which is defined as a rise above nadir PSA + 2 ng/ml.

  5 years

Secondary Outcomes (1)

• The secondary aim is to obtain quality of life data to examine the potential complications associated with SBRT: detailed symptom questionnaire

  5 years

Study Arms (2)

Elekta Versa HD

ACTIVE COMPARATOR

This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Elekta machines, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT.

Radiation: Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.

Agility Systems

OTHER

This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Agility Systems, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT.

Radiation: Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.

Interventions

Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. RADIATION

SBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. The Elekta Versa and Agility Systems are approved by the Food and Drug Association (FDA) for SBRT treatment of cancer.

Also known as: Cyberknife

Agility Systems; Elekta Versa HD

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is open to patients with a pathologic diagnosis of localized prostate cancer and have expressed a desire to receive SBRT over other therapies
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of adenocarcinoma of the prostate History/physical examination with digital rectal examination of the prostate
• Histological evaluation of prostate biopsy with assignment of Gleason score to the biopsy material.
• Clinical stage T1-3 (AJCC 7th edition).
• Males age ≥ 18
• Patient must be able to provide study-specific informed consent prior to study entry.
• Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

You may not qualify if:

• Evidence of distant metastases
• Regional lymph node involvement
• Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
• Previous pelvic irradiation, prostate brachytherapy
• Previous or concurrent cytotoxic chemotherapy for prostate cancer
• No life expectancy restrictions will apply
• Performance Status will not be considered

Sponsors & Collaborators

• Hoag Memorial Hospital Presbyterian: lead

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery; Radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Model Details: SBRT for the management of localized prostate cancer is a Phase II non-randomized clinical trial open to patients with biopsy proven localized prostate cancer. Patients will be deemed eligible for SBRT in any risk group categorization based upon the standard D'Amico stratification: * Low-risk: initial PSA \<10 and clinical stage T1c-T2a/b and biopsy Gleason grade 3+3 * Intermediate-risk: initial PSA \>10 but \<20 or clinical stage T2c or biopsy Gleason grade 3+4 or 4+3 * High-risk: initial PSA \>20 or clinical stage T3 or biopsy Gleason grade 4+4 or higher).

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 26, 2019
• Study Start: October 21, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)