The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife

Prostate Cancer Clinical Trial

— SPARC  

Official title:

Stereotactic Prostate Augmented Radiotherapy With Cyberknife

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02145494
• Other study ID #: 13/LO/0109
• Secondary ID: CCR 3923
• Status: Recruiting
• Phase: Phase 2
• First received: June 4, 2013
• Last updated: May 20, 2014
• Start date: June 2013
• Est. completion date: December 2018

Study information

• Verified date: May 2014
• Source: Royal Marsden NHS Foundation Trust
• Contact: Nicholas J van As, FRCR
• Phone: 02078118336
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Acute gastrointestinal (GI) toxicity	RTOG scale	Within 12 weeks of treatment completion	Yes
Secondary	Late GI and GU toxicity	RTOG scale	From 12 weeks until study completion	Yes
Secondary	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	Yes
Secondary	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	No