Clinical Trials /

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

NCT02296229

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer
  • Official Title: Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 13-001427
  • SECONDARY ID: NCI-2014-02183
  • SECONDARY ID: JCCCID410
  • SECONDARY ID: 13-001427
  • SECONDARY ID: P30CA016042
  • NCT ID: NCT02296229

Conditions

  • Adenocarcinoma of the Prostate
  • Stage III Prostate Cancer

Interventions

DrugSynonymsArms
androgen deprivation therapyandrogen suppression therapyTreatment (SBRT)

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (SBRT)ExperimentalPatients 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.
  • androgen deprivation therapy

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Biochemical progression free survival
Time Frame:At 3 years
Safety Issue:
Description:Biochemical progression is defined as rising PSA profile of > 2 ng/mL above post-SBRT nadir.

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Jonsson Comprehensive Cancer Center

Last Updated

September 7, 2016