Clinical trial NCT01859221: Radiotherapy for Oligometastatic Prostate Cancer
Official title: Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oligometastatic Prostate Cancer
Keywords: Prostate cancer
Oligometastatic prostate cancer
Proton radiation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone receptive and castration resistant subgroups.
timeFrame: 78 months after radiation treatment
Secondary outcomes:
measure: Improvement in overall survival of patients with metastatic prostate cancer.
timeFrame: 78 months after radiation treatment
measure: Treatment failure rates in patients treated with stereotactic radiation for metastatic prostate cancer.
timeFrame: 78 months after radiation treatment
measure: Quality of life in patients treated with stereotactic radiation for metastatic prostate cancer.
timeFrame: 78 months after radiation treatment
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Roi Dagan, MD, MS
role: PRINCIPAL_INVESTIGATOR
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