Radiotherapy for Oligometastatic Prostate Cancer

Study Overview
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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.

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.

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

Conditions
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Oligometastatic Prostate Cancer

Intervention / Treatment
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* Radiation: Stereotactic radiation


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Castration Resistant<br>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. | Radiation: Stereotactic radiation<br>* Stereotactic radiation<br>|
| Experimental: Hormone Receptive<br>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. | Radiation: Stereotactic radiation<br>* Stereotactic radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Oligometastatic prostate cancer, Proton radiation