NCT02145494

The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife

Stereotactic Prostate Augmented Radiotherapy With Cyberknife

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Radiotherapy	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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-12-01
• Completion: 2018-12-01
• First posted: 2014-05-23
• Last updated: 2014-05-23

Locations

1 site across 1 country: United Kingdom