The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife

Phase 2

• Conditions: Prostate Cancer
• Interventions: Radiation: Radiotherapy

• Registration Number: NCT02145494
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief 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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-04
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-20
• Last Update Submitted: 2014-05-20
• Study First Posted: 2014-05-23
• Last Update Posted: 2014-05-23
• Primary Completion: 2015-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Radiotherapy	Radiotherapy

Primary Outcome Measures

Name	Time	Method
Acute genitourinary(GU) toxicity	Maximal recorded toxicity within the acute toxicity period (up to 12 weeks)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal Marsden NHS Foundation trust; 🇬🇧 London, United Kingdom