The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife

Study Overview
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Brief Summary
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Giving a higher dose of radiation to the dominant tumour nodule within the prostate is hypothesized to improve tumour control. This trial will assess whether this technique, delivered in 5 treatments, can be delivered without increasing side effects.

Detailed Description
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Aim To assess if a focal boost can be delivered to the dominant tumour nodule alongside 36.25 Gy in 5 fractions to the whole prostate gland. Primary end-point: Acute toxicity (Radiation Therapy Oncology Group (RTOG), International prostate symptom score (IPSS)) Secondary end-points: Prostate specific antigen (PSA) nadir and 2-year biochemical control Late toxicity (IPSS, RTOG, International index of erectile function (IIEF-5)) Quality of life (EQ5D scale) Inclusion criteria Prostate cancer patients with any of the following: PSA>20 Gleason grade 4+3 or higher Stage T3a Exclusion criteria Nodal or metastatic disease PSA>40 Stage T3b or higher Study interventions This is a phase II study which will recruit 20 patients. A dose of 36.25 Gy in 5 fractions will be delivered to the whole prostate with a simultaneous integrated boost up to 47.5 Gy in 5 fractions or to the highest dose possible within dose constraints. The boost volume will be defined on the multiparametric magnetic resonance scan by the specialist radiologist.

Official Title
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Stereotactic Prostate Augmented Radiotherapy With Cyberknife

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostate cancer patients with any of the following: PSA 20-40 Gleason grade 4+3 or higher Stage T3a Exclusion Criteria: Nodal or metastatic disease PSA>40 Stage T3b or higher
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: Treatment<br>Radiotherapy | Radiation: Radiotherapy<br>* Stereotactic body radiotherapy (SBRT) to the whole prostate (36.25 Gy in 5 fractions) with a focal boost (47.5 Gy in 5 fractions) to the MRI-defined dominant tumour nodule.<br>* Other names: Cyberknife;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute genitourinary(GU) toxicity | RTOG scale acute GU toxicity will be measured at baseline, end of treatment, then 2,4 and 12 weeks post treatment. The maximal toxicity during follow up is the primary outcome measure. | Maximal recorded toxicity within the acute toxicity period (up to 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute gastrointestinal (GI) toxicity | RTOG scale | Within 12 weeks of treatment completion | 
| Late GI and GU toxicity | RTOG scale | From 12 weeks until study completion | 
| Patient reported outcomes i.e. IPSS, IIEF-5 and EQ5-D | IPSS, IIEF-5 and EQ5-D | Baseline, 12 weeks, 12 months and 6 monthly to 5 years | 
| Biochemical relapse-free survival | PSA will be measured 3-6 monthly during study | Measured at 12 weeks after completion of treatment and 3-6 monthly to 5 years thereafter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SBRT (stereotactic body radiotherapy), Focal boost, Prostate