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

Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer

This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage III Prostate Cancer; Adenocarcinoma of the Prostate
• Intervention / Treatment: Other: laboratory biomarker analysis; Other: quality-of-life assessment; Radiation: stereotactic body radiation therapy; Drug: androgen deprivation therapy

Detailed Description

PRIMARY OBJECTIVES:

I. To establish the efficacy of stereotactic body radiation therapy (SBRT) in patients with high-risk localized prostate cancer compared to historical data from clinical trials.

II. To establish the safety with physician-reported outcomes after SBRT in patients with high risk localized prostate cancer.

III. To establish the quality of life with patient-reported validated questionnaires after SBRT in patients with high risk localized prostate cancer.

OUTLINE:

Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.

After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 5 years, and then every 12 months thereafter.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed primary non-metastatic adenocarcinoma of the prostate

• Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group, as defined by the presence of any one of the following high-risk factors:

  • Pre-biopsy prostate-specific antigen (PSA) >= 20
  • Biopsy Gleason score 8-10
  • Clinical stage T3
• No pelvic nodal metastases (based on computed tomography [CT] or magnetic resonance imaging [MRI] findings)

• No distant metastases, based upon:

  • CT scan or MRI of the pelvis within 120 days prior to registration
  • Bone scan 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
• Karnofsky performance status (KPS) >= 70
• Ability to understand, and willingness to sign, the written informed consent
• Patient will have opted for SBRT among definitive treatment choices

Exclusion Criteria:

• Patients with any evidence of distant metastases
• Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registration
• Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
• Prior pelvic radiotherapy
• History of Crohn’s disease or Ulcerative colitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (SBRT); Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.

Other: laboratory biomarker analysis; Correlative studies; Other: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Radiation: stereotactic body radiation therapy; Undergo SBRT; Other Names: SBRT; stereotactic radiation therapy; stereotactic radiotherapy; Drug: androgen deprivation therapy; up to 9 months at the discretion of the treating physician; Other Names: androgen suppression therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical progression free survival	Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.	At 3 years
Biochemical progression free survival	Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.	At 5 years
Incidence of patient-reported genitourinary (GU) and gastrointestinal (GI) toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4		At 4 months
Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4		Up to 5 years
Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire		Baseline to up to 5 years

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Investigators: Principal Investigator: Amar Kishan, Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2014
• Primary Completion (Actual): January 27, 2026
• Study Completion (Estimated): January 27, 2027

Study Registration Dates

• First Submitted: November 13, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimated): November 20, 2014

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Pharmacologic Actions; Chemical Actions and Uses; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Androgen Antagonists; Radiosurgery
• Other Study ID Numbers: 13-001427 (Other Identifier: University of California at Los Angeles Institutional Review Board); NCI-2014-02183 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); JCCCID410 (Other Identifier: Jonsson Comprehensive Cancer Center)