Prospective Evaluation of Stereotactic Body Radiotherapy for Metastatic Prostate Cancer

Overview

The investigators aim to test the safety and feasibility of prostate gland stereotactic body radiotherapy (SBRT) plus best systemic therapy in newly diagnosed metastatic prostate cancer.

Full Title of Study: “PROSPECTIVE EVALUATION OF STEREOTACTIC BODY RADIOTHERAPY FOR METASTATIC PROSTATE CANCER”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 17, 2018

Detailed Description

The investigators and other investigators have previously documented the safety and efficacy of definitive intent stereotactic body radiotherapy (SBRT) in the treatment of localized prostate cancer. In the metastatic setting for multiple malignancies, improved survival rates and disease outcomes have been shown with definitive treatment of the primary disease site. This concept of "cytoreductive" surgery or decreasing the primary tumor burden is now considered the standard of care for metastatic colon, ovarian, renal cell, and some breast carcinomas (plus post-surgery irradiation). With new guidelines and declining rates of PSA screening, the incidence of newly diagnosed metastatic prostate cancer is expected to increase. A recent population-based study has concluded significant improvements in the definitive treatment of the local prostate cancer in the stage IV setting with either radical prostatectomy or conventional prostate radiation treatments/brachytherapy. To our knowledge, one prospective phase II trial is currently accruing patients to best systemic therapy or best systemic therapy (BST) plus definitive treatment with either radical prostatectomy or conventionally fractionated radiation therapy The investigators hypothesize that the addition of primary disease SBRT to best systemic therapy for newly diagnosed metastatic prostate cancer would be associated with an acceptable safety profile, quality of life, disease progression, and overall survival. The addition of SBRT to best systemic therapy is also expected to be better-received for stage IV patients (with relatively limited prognosis), vs. fully fractionated radiation therapy, brachytherapy, or radical prostatectomy. The above endpoints would initially be tested in a prospective phase II multi-institutional trial and in comparison with historical controls.

Interventions

  • Radiation: STEREOTACTIC BODY RADIOTHERAPY to the prostate gland

Arms, Groups and Cohorts

  • Experimental: STEREOTACTIC BODY RADIOTHERAPY
    • STEREOTACTIC BODY RADIOTHERAPY to the prostate gland

Clinical Trial Outcome Measures

Primary Measures

  • Radiation related toxicity
    • Time Frame: 5 years
    • Radiation related toxicity as per history and physical, and 1 or several of Patient questionnaires: SF-12 questionnaire AUA questionnaire EPIC-26 questionnaire SHIM questionnaire Utilization of Sexual Medications/Devices questionnaire

Secondary Measures

  • Feasibility
    • Time Frame: 3-4 years
    • Feasibility in terms of accrual and practical treatment delivery

Participating in This Clinical Trial

Inclusion Criteria

  • Histologically-confirmed, adenocarcinoma of the prostate – Clinical Stage T1b – T4, NX-0-1, M1 – Any Gleason score – PSA<1000 – ECOG Performance Status 0-2 – No prior prostate radiation or other definitive therapy Exclusion Criteria:

  • Prior prostatectomy or cryotherapy of the prostate – Prior radiotherapy to the prostate or lower pelvis – Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion – Chemotherapy for a malignancy in the last 5 years – History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sharp HealthCare
  • Provider of Information About this Clinical Study
    • Sponsor

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