The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife
SPARC
Stereotactic Prostate Augmented Radiotherapy With Cyberknife
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 prostate-cancer
Started Jun 2013
Typical duration for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 4, 2013
CompletedFirst Posted
Study publicly available on registry
May 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 23, 2014
May 1, 2014
2.5 years
June 4, 2013
May 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (4)
Acute gastrointestinal (GI) toxicity
Within 12 weeks of treatment completion
Late GI and GU toxicity
From 12 weeks until study completion
Patient reported outcomes i.e. IPSS, IIEF-5 and EQ5-D
Baseline, 12 weeks, 12 months and 6 monthly to 5 years
Biochemical relapse-free survival
Measured at 12 weeks after completion of treatment and 3-6 monthly to 5 years thereafter
Study Arms (1)
Treatment
EXPERIMENTALRadiotherapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- Prostate cancer patients with any of the following:
- PSA 20-40
- Gleason grade 4+3 or higher
- Stage T3a
You may not qualify if:
- Nodal or metastatic disease
- PSA\>40
- Stage T3b or higher
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Marsden NHS Foundation trust
London, SW3 6JJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2013
First Posted
May 23, 2014
Study Start
June 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2018
Last Updated
May 23, 2014
Record last verified: 2014-05