Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
39 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-05-31
Study Completion Date
2022-09-13
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Oligometastatic Prostate Cancer
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Castration Resistant
There are two different prognostic categories, hormones receptive and castration resistant, that have differing historical disease progression rates. We have therefore stratified the trial so that we can independently monitor the hypothesized improvement provided by radiation therapy in these two groups. Both groups will receive the same radiation modality which is interventional stereotactic radiation with two possible schedules of SBRT and SHRT.
Group Type
EXPERIMENTAL
Stereotactic radiation
Intervention Type
RADIATION
Stereotactic radiation
Hormone Receptive
There are two different prognostic categories, hormones receptive and castration resistant, that have differing historical disease progression rates. We have therefore stratified the trial so that we can independently monitor the hypothesized improvement provided by radiation therapy in these two groups. Both groups will receive the same radiation modality which is interventional stereotactic radiation with two possible schedules of SBRT and SHRT.
Group Type
EXPERIMENTAL
Stereotactic radiation
Intervention Type
RADIATION
Stereotactic radiation
Interventions
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Stereotactic radiation
Stereotactic radiation
Intervention Type
RADIATION
Eligibility Criteria
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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.
* 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.
* End-stage liver disease,
* End-stage renal disease,
* End stage pulmonary disease
* Current brain or central nervous system metastasis.
Minimum Eligible Age
18 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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University of Florida
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Roi Dagan, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Site Status
Countries
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United States
References
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Other Identifiers
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IRB201702654
Identifier Type: OTHER
Identifier Source: secondary_id
UFPTI 1301-OL01
Identifier Type: -
Identifier Source: org_study_id
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