This study is in progress, not accepting new patients

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

a study on Prostate Cancer

Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around

Description

Summary

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.

Official Title

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

Details

PRIMARY OBJECTIVES:

  1. 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.

Keywords

Adenocarcinoma of the Prostate, Stage III Prostate Cancer, Prostatic Neoplasms, Androgens, stereotactic body radiation therapy, quality-of-life assessment, laboratory biomarker analysis, androgen deprivation therapy

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • Jonsson Comprehensive Cancer Center
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT02296229
Study Type
Interventional
Participants
Expecting 220 study participants
Last Updated