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The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife (SPARC)

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring SBRT (stereotactic body radiotherapy), Focal boost, Prostate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Marsden NHS Foundation trustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Radiotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acute gastrointestinal (GI) toxicity
RTOG scale
Late GI and GU toxicity
RTOG scale
Patient reported outcomes i.e. IPSS, IIEF-5 and EQ5-D
IPSS, IIEF-5 and EQ5-D
Biochemical relapse-free survival
PSA will be measured 3-6 monthly during study

Full Information

First Posted
June 4, 2013
Last Updated
May 20, 2014
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02145494
Brief Title
The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife
Acronym
SPARC
Official Title
Stereotactic Prostate Augmented Radiotherapy With Cyberknife
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
SBRT (stereotactic body radiotherapy), Focal boost, Prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
Cyberknife
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute genitourinary(GU) toxicity
Description
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.
Time Frame
Maximal recorded toxicity within the acute toxicity period (up to 12 weeks)
Secondary Outcome Measure Information:
Title
Acute gastrointestinal (GI) toxicity
Description
RTOG scale
Time Frame
Within 12 weeks of treatment completion
Title
Late GI and GU toxicity
Description
RTOG scale
Time Frame
From 12 weeks until study completion
Title
Patient reported outcomes i.e. IPSS, IIEF-5 and EQ5-D
Description
IPSS, IIEF-5 and EQ5-D
Time Frame
Baseline, 12 weeks, 12 months and 6 monthly to 5 years
Title
Biochemical relapse-free survival
Description
PSA will be measured 3-6 monthly during study
Time Frame
Measured at 12 weeks after completion of treatment and 3-6 monthly to 5 years thereafter

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas J van As, FRCR
Phone
02078118336
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel R Henderson, FRCR
Phone
02078118469
Facility Information:
Facility Name
Royal Marsden NHS Foundation trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel R Henderson, FRCR
Email
daniel.henderson@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Nicholas J van As, FRCR
First Name & Middle Initial & Last Name & Degree
Alison C Tree, FRCR

12. IPD Sharing Statement

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The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife

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