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NCT02296229Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 25 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
220 (estimated)
First submitted
13 Nov 2014
Start date
27 Jan 2014
Primary completion date
27 Jan 2026
Lead sponsor
Jonsson Comprehensive Cancer Center
NCT number
NCT02296229

What you commit to

  • Study type: Interventional
  • Planned participants: 220
  • From 27 Jan 2014 to the primary completion date, 27 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • History of Crohn’s disease or Ulcerative colitis

Other

  • Patients with any evidence of distant metastases

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jonsson Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.