Clinical Trials /

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

NCT02830165

Description:

This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
  • Official Title: Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy

Clinical Trial IDs

  • ORG STUDY ID: 15-001580
  • SECONDARY ID: NCI-2016-00188
  • SECONDARY ID: JCCCID608
  • SECONDARY ID: 15-001580
  • SECONDARY ID: P30CA016042
  • NCT ID: NCT02830165

Conditions

  • Stage I Prostate Adenocarcinoma
  • Stage II Prostate Adenocarcinoma
  • Stage III Prostate Adenocarcinoma

Purpose

This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate
      cancer patients at high risk for recurrence after prostatectomy.

      SECONDARY OBJECTIVES:

      I. To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based
      on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported
      quality of life (Expanded Prostate Cancer Index Composite [EPIC] and International Prostate
      Symptom Score [IPSS] questionnaires).

      II. Correlative biomarker and molecular analyses using the primary tumor specimen and serial
      blood draws before and after treatment.

      OUTLINE:

      Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical
      prostatectomy.

      After completion of the study treatment, patients are followed up every 3 months for 1 year.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (SBRT)ExperimentalPatients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
    
              -  Patient desires and is medically fit to undergo prostatectomy
    
              -  Karnofsky performance status (KPS) >= 70
    
              -  Patients on androgen deprivation therapy (ADT) are allowed
    
              -  For confirmation of high risk local failure status, patients will have any one of the
                 following:
    
                   -  Computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating
                      seminal vesicle invasion (SVI) or extraprostatic extension (EPE) within 1 year
                      of enrollment into the study
    
                   -  Pre-biopsy prostate-specific antigen (PSA) >= 20
    
                   -  Gleason score 7-10 (Gleason 7 must be 4+3), presence of any Gleason 5 (even if a
                      tertiary score) as determined at diagnostic biopsy
    
                   -  Gleason score 7 and > 50% of biopsy cores positive for prostate cancer
    
                   -  Clinical stage >= T3 (staging by imaging acceptable)
    
              -  An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is
                 encouraged but not required if not performed as standard of care biopsy
    
            Exclusion Criteria:
    
              -  Distant metastases, based upon:
    
                   -  CT scan or MRI of the abdomen/pelvis within 120 days prior to registration and
    
                   -  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 prior to
                      registration
    
              -  Patient is unable or unwilling to sign consent
    
              -  Patient is considered low-risk and would not have received adjuvant radiation therapy
                 (RT) outside of this study
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Treatment Completion Rate of Pre-Operative stereotactic body radiotherapy (SBRT).
    Time Frame:At 4 weeks
    Safety Issue:
    Description:A two-sided 90% exact binomial confidence interval will be used to measure the treatment completion rate.

    Secondary Outcome Measures

    Measure:Changes in quality of life, based on the International Prostate Symptom Score (I-PSS) questionnaire
    Time Frame:Baseline to up to 1 year
    Safety Issue:
    Description:
    Measure:Correlative biomarker analyses using tissue and serial blood samples
    Time Frame:Baseline and to up to 1 year
    Safety Issue:
    Description:Tissue specimens of the primary tumor as well as blood draws before and after treatment will be used to conduct biomarker and molecular analyses relevant to understanding the biology of prostate stereotactic body radiation therapy (SBRT)
    Measure:Incidence of toxicities, based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4
    Time Frame:Up to 1 year
    Safety Issue:
    Description:
    Measure:Changes in quality of life, based on the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
    Time Frame:Baseline to up to 1 year
    Safety Issue:
    Description:

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Jonsson Comprehensive Cancer Center

    Last Updated

    September 22, 2016