SABR Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)

Study Overview
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Brief Summary
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Current treatment options for high risk localized prostate cancer include radical prostatectomy +/- postoperative radiotherapy, radical radiotherapy with androgen deprivation therapy. Evidence has emerged that prostate cancer has a low α/β ratio in the range of 1-3 Gy. Even with high risk tumors, prostate cancer is hypothesized to have a greater sensitivity to large fraction sizes and high dose per fraction radiotherapy theoretically allows for biological dose escalation with fewer visits and no additional toxicity. Therefore, we hope to determine the toxicity, quality of life, biochemical and pathological control of SBRT for high risk prostate cancer incorporating ENI.

Official Title
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Phase II Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Stereotactic ablative radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent obtained men > 18 years of age histologically confirmed prostate adenocarcinoma (centrally reviewed) high risk prostate cancer, defined as at least one of clinical stage T3 or Gleason 8-10, or PSA > 20ng/mL Exclusion Criteria: prior pelvic radiotherapy anticoagulation medication (if unsafe to discontinue for gold seed insertion) diagnosis of bleeding diathesis large prostate (>90cm3) on imaging at time of gold seed insertion no evidence of castrate resistance (defined as PSA < 3ng/mL while testosterone is < 0.7nmol/L definitive regional or distant metastatic disease on staging investigations

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic ablative radiotherapy<br>40 Gy in 5 fractions over 4 weeks to prostate; 25 Gy in 5 fractions over 4 weeks to pelvic lymph nodes given simulataneously. | Radiation: Stereotactic ablative radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute GU and GI toxicities | Acute GU and GI toxicities as assessed using the Common Terminology for Adverse Events (CTCAE) v3.0 | Baseline to 3 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late GU and GI toxicities | Late GU and GI toxicities as assessed using RTOG grading schema | > 6 months post treatment | 
| Quality of Life (QoL) | Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire | 5 years | 
| Biochemical control | Biochemical disease free survival | 5 years | 
| Disease free survival | Prostate biopsy 2 years post ADT cessation | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stereotactic ablative radiotherapy, androgen deprivation therapy