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NCT Number: NCT02296229

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Adenocarcinoma of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Stage III Prostate Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Body Radiation Therapy

Radiation

Undergo SBRT

Other names: SBRT, stereotactic radiation therapy, stereotactic radiotherapy

Quality-of-Life Assessment

Other

Ancillary studies

Other names: quality of life assessment

laboratory biomarker analysis

Other

Correlative studies

Androgen Deprivation Therapy

Drug

up to 9 months at the discretion of the treating physician

Other names: androgen suppression therapy

Primary outcomes

  1. Biochemical progression free survival

    Time frame: At 3 years

    Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.

  2. Biochemical progression free survival

    Time frame: At 5 years

    Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.

  3. Incidence of patient-reported genitourinary (GU) and gastrointestinal (GI) toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4

    Time frame: At 4 months

  4. Incidence of patient-reported GU and GI toxicity based on the CTCAE version 4

    Time frame: Up to 5 years

  5. Changes in health related quality of life based on Expanded Prostate Cancer Index Composite questionnaire

    Time frame: Baseline to up to 5 years

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2026
Study completion
2027
First posted
Nov 20, 2014
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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