The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife
NCT ID: NCT02145494
Last Updated: 2014-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2013-06-30
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Radiotherapy
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PSA 20-40
* Gleason grade 4+3 or higher
* Stage T3a
Exclusion Criteria
* PSA\>40
* Stage T3b or higher
MALE
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Royal Marsden NHS Foundation trust
London, , United Kingdom
Countries
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Central Contacts
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Nicholas J van As, FRCR
Role: CONTACT
Daniel R Henderson, FRCR
Role: CONTACT
Facility Contacts
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Other Identifiers
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CCR 3923
Identifier Type: OTHER
Identifier Source: secondary_id
13/LO/0109
Identifier Type: -
Identifier Source: org_study_id
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