Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to find out the effects (good and bad) of highly focused radiation on you and your prostate cancer. The purpose of this evaluation is to see if this treatment causes fewer side effects that other standard treatment approaches, and to evaluate the effect of this treatment on your prostate tumor and your quality of life over time.

Official Title
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Function-Preserving Stereotactic Body Radiotherapy for Clinical State I-III Prostate Cancer

Conditions
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Prostate Cancer, Prostatic Cancer, Prostate Neoplasms, Prostatic Neoplasms, Cancer of the Prostate

Intervention / Treatment
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* Radiation: CyberKnife Stereotactic Radiosurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven prostate adenocarcinoma Clinical stage T1a-T3, N0-Nx, M0-Mx Patients belonging in one of the following risk groups: (1) LOW RISK: CS T1a-T2a, Gleason 2-6, PSA<10, Nx-0, Mx-0; (2) INTERMEDIATE RISK: CS T2b, Gleason ≤7, PSA<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 2-6, PSA≥10 & <20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 7, PSA≤20, Nx-0, Mx-0; or (3) HIGH RISK: CS T2c-T3, any Gleason, any PSA, or CS T1-3, Gleason ≥8 and/or PSA≥20 Karnofsky performance status 70-100 Hormone therapy: includes LHRH agonists (e.g. leuprolide, goserelin, triptorelin), antagonists (e.g. degarelix), peripheral blockers (e.g. flutamide, bicalutamide, nilutamide), estrogens (e.g. DES) and bilateral orchiectomy Low and Intermediate risk groups: no hormone ablation for two months prior to enrollment, or during treatment High risk group: three hormone therapy regimens are allowed 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed Exclusion Criteria: Prior prostatectomy or cryotherapy of the prostate Prior high-dose radiotherapy to the prostate or lower pelvis Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CyberKnife Stereotactic Radiosurgery<br>This treatment concentrates large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. CyberKnife Stereotactic Radiosurgery is not investigational and is considered standard of care. | Radiation: CyberKnife Stereotactic Radiosurgery<br>* Five treatments given over about one week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life outcomes (low- and intermediate-risk prostate cancer groups) | In the low- and intermediate-risk prostate cancer groups, to determine whether study treatment improves patient-reported quality of life outcomes compared to the approach used in a previous multi-center cyberknife stereotactic radiosurgery trial. | 8 years | 
| Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group) | In the high-risk group, to estimate rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities following cyberknife stereotactic radiosurgery. | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of toxicities related to treatment | After five years following cyberknife stereotactic radiosurgery, estimate rates of toxicities related to treatment. | 5 years | 
| Disease free survival | Measure disease free survival after five years following cyberknife stereotactic radiosurgery. | 5 years | 
| Overall survival | Measure overall survival after five years following cyberknife stereotactic radiosurgery. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation, Stereotactic Radiosurgery, Radiotherapy, Prostate Tumor, Prostate Surgery, CyberKnife