An interventional study of STEREOTACTIC BODY RADIOTHERAPY to the prostate gland in Metastatic Prostate Cancer, sponsored by Sharp HealthCare. Withdrawn at 1 site in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-20.
Sponsored by Sharp HealthCare · Not applicable, Interventional, and Treatment
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
Browse Prostatic Neoplasms studies →Sharp HealthCare is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
STEREOTACTIC BODY RADIOTHERAPY to the prostate gland
Radiation: STEREOTACTIC BODY RADIOTHERAPY to the prostate gland
Radiation related toxicity
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
Time frame: 5 years
Feasibility
Feasibility in terms of accrual and practical treatment delivery
Time frame: 3-4 years
This study is withdrawn, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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