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

May 20, 2014 updated by: Royal Marsden NHS Foundation Trust

Stereotactic Prostate Augmented Radiotherapy With Cyberknife

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Nicholas J van As, FRCR
        • Sub-Investigator:
          • Alison C Tree, FRCR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Radiotherapy
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.
Other Names:
  • Cyberknife

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute genitourinary(GU) toxicity
Time Frame: 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.
Maximal recorded toxicity within the acute toxicity period (up to 12 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Estimate)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/LO/0109
  • CCR 3923 (Other Identifier: Royal Marsden NHS Foundation Trust)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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