The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife — SPARC  

Prostate Cancer Clinical Trial

Official title: Stereotactic Prostate Augmented Radiotherapy With Cyberknife

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer

• NCT number: NCT02145494
• Study type: Interventional
• Source: Royal Marsden NHS Foundation Trust
• Contact: Nicholas J van As, FRCR
• Phone: 02078118336
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2013
• Completion date: December 2018