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

Status: Active

Description

This 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 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. 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.

Eligibility Criteria

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

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Christopher R. King
Phone: 424-259-8777
Email: crking@mednet.ucla.edu
West Covina
Advanced Oncology Center Inc
Status: Approved
Contact: Kevin Lin
Phone: 626-956-8089
Email: kevinlin@aoctr.com

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Observational

Lead Organization

Lead Organization
UCLA / Jonsson Comprehensive Cancer Center

Principal Investigator
Christopher R. King

Trial IDs

Primary ID 13-001427
Secondary IDs NCI-2014-02183, JCCCID410
Clinicaltrials.gov ID NCT02296229