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Radiotherapy for Oligometastatic Prostate Cancer

Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Oligometastatic Prostate Cancer

Intervention: SBRT/SHRT (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Florida

Official(s) and/or principal investigator(s):
Roi Dagan, MD, MS, Principal Investigator, Affiliation: University of Florida

Overall contact:
Intake Coordinator, Phone: 877-686-6009


The purpose of this phase II study is to evaluate the outcomes of patients treated with an investigational radiation regimen using stereotactic radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a desired result or effect) and safety in this setting.

Clinical Details

Official title: Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone receptive and castration resistant subgroups.

Secondary outcome:

Improvement in overall survival of patients with metastatic prostate cancer.

Treatment failure rates in patients treated with stereotactic radiation for metastatic prostate cancer.

Quality of life in patients treated with stereotactic radiation for metastatic prostate cancer.

Detailed description: This study will serve as a component of a larger program investigating the benefits of stereotactic radiotherapy in patients with metastatic disease. This particular study will serve as a benchmark analysis. All patients will receive stereotactic radiotherapy directed at metastatic tumors. If primary prostate cancer is active and has not previously been treated with radiation therapy, conventional radiation therapy (6-8 weeks of daily treatment) may be recommended. The metastatic tumor will be treated at the same time. Hormone therapy will be recommended for all patients. Patients will be asked to complete questionnaires at regular intervals.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.


Inclusion Criteria:

- Patients with metastatic cancer of the prostate,

- Patients may have received prior surgery,

- Prior radiation therapy, androgen deprivation therapy (ADT), immunotherapy, bone

metastasis directed therapy, or chemotherapy for prostate cancer. Exclusion Criteria:

- End-stage heart disease,

- End-stage liver disease,

- End-stage renal disease,

- End stage pulmonary disease

- Current brain or central nervous system metastasis.

Locations and Contacts

Intake Coordinator, Phone: 877-686-6009

University of Florida Proton Therapy Institute, Jacksonville, Florida 32206, United States; Recruiting
Intake Coordinator, Phone: 877-686-6009
Roi Dagan, MD, MS, Principal Investigator
Additional Information

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Starting date: May 2013
Last updated: April 14, 2015

Page last updated: August 23, 2015

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