5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:

Study Overview
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Brief Summary
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Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. 5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.

Official Title
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5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Histologically confirmed prostate adenocarcinoma (centrally reviewed) High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml, High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL Willing to give informed consent to participate in this clinical trial Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires Exclusion Criteria Prior pelvic radiotherapy Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease Anticoagulation medication (if unsafe to discontinue for fiducial insertion) Diagnosis of bleeding diathesis Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20 Evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression. Definitive extrapelvic nodal or distant metastatic disease on staging investigations. Hip prosthesis

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 Body Radiotherapy (SABR) 35-50 Gy/5<br>Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT. | Radiation: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5<br>* Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Toxicity | To document the acute urinary toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria | Baseline to 3 months post completion of treatment | 
| Acute Toxicity | To document the acute bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria | Baseline to 3 months post completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life outcome | Measuring quality of life using Expanded Prostate Index Composite (EPIC) | Baseline to end of 5 year follow up | 
| Biochemical disease-free survival | Biochemical disease-free survival | Baseline to end of 5 year follow up | 
| Quality of life outcome | Health utilities using the EQ-5D Quality of Life Questionnaire tool | Baseline to end of 5 year follow up | 
| Quality of life outcome | Health utilities using PORPUS-U Quality of Life Questionnaire tool | Baseline to end of 5 year follow up | 
| Economic analysis | Cost effectiveness of treatment.Quality of life and cost estimates will be captured for each patient from time of the initiation of treatment until death. The effectiveness endpoints will be biochemical disease free survival and quality-adjusted life years (QALYs). QALY will be calculated by survival (in years) multiplied by a utility weight associated with a certain condition. | Baseline to end of 5 year follow up |