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Prospective Evaluation of Stereotactic Body Radiotherapy for Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02206724
Recruitment Status : Withdrawn (Unable to enroll patients)
First Posted : August 1, 2014
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Sharp HealthCare

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Prostate Cancer Radiation: STEREOTACTIC BODY RADIOTHERAPY to the prostate gland Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PROSPECTIVE EVALUATION OF STEREOTACTIC BODY RADIOTHERAPY FOR METASTATIC PROSTATE CANCER
Actual Study Start Date : July 16, 2014
Actual Primary Completion Date : April 17, 2018
Actual Study Completion Date : April 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: STEREOTACTIC BODY RADIOTHERAPY
STEREOTACTIC BODY RADIOTHERAPY to the prostate gland
Radiation: STEREOTACTIC BODY RADIOTHERAPY to the prostate gland



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Feasibility [ Time Frame: 3-4 years ]
    Feasibility in terms of accrual and practical treatment delivery



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206724


Locations
United States, California
Sharp Healthcare
San Diego, California, United States, 92123
Sponsors and Collaborators
Sharp HealthCare

Responsible Party: Sharp HealthCare
ClinicalTrials.gov Identifier: NCT02206724     History of Changes
Other Study ID Numbers: 140794
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by Sharp HealthCare:
Metastatic prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases