Oligometastatic Prostate Cancer Clinical Trial
Official title:
Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer
Verified date | September 2022 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | September 13, 2022 |
Est. primary completion date | September 13, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida Proton Therapy Institute | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone receptive and castration resistant subgroups. | Over the 78 month period, any occurrence of toxicity and/or treatment failure will be monitored via regular patient follow-up interviews. The cumulative rate at 78 months is analytic outcome of interest for each type of secondary outcome. | 78 months after radiation treatment | |
Secondary | Improvement in overall survival of patients with metastatic prostate cancer. | Over the 78 month period, any occurrence of toxicity and/or treatment failure will be monitored via regular patient follow-up interviews. The cumulative rate at 78 months is analytic outcome of interest for each type of secondary outcome. | 78 months after radiation treatment | |
Secondary | Treatment failure rates in patients treated with stereotactic radiation for metastatic prostate cancer. | Over the 78 month period, any occurrence of toxicity and/or treatment failure will be monitored via regular patient follow-up interviews. The cumulative rate at 78 months is analytic outcome of interest for each type of secondary outcome. | 78 months after radiation treatment | |
Secondary | Quality of life in patients treated with stereotactic radiation for metastatic prostate cancer. | Over the 78 month period, any occurrence of toxicity and/or treatment failure will be monitored via regular patient follow-up interviews. The cumulative rate at 78 months is analytic outcome of interest for each type of secondary outcome. | 78 months after radiation treatment |
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