Prostate CancerPhase 2SPARCNCT02145494
The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife
A Phase 2 study testing Radiotherapy in people with Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prostate cancer patients with any of the following:
- PSA 20-40
- Gleason grade 4+3 or higher
- Stage T3a
Who cannot join
- Nodal or metastatic disease
- PSA>40
- Stage T3b or higher
Trial locations and contacts
1 site in 1 country.
Nicholas J van As, FRCR contact
Daniel R Henderson, FRCR contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation trust
London, SW3 6JJ
Daniel R Henderson, FRCR, daniel.henderson@rmh.nhs.uk
Nicholas J van As, FRCR
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Radiotherapy
- Keywords
- SBRT (stereotactic body radiotherapy), Focal boost, Prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called Cyberknife
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Radiotherapy Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Maximal recorded toxicity within the acute toxicity period (up to 12 weeks)
Secondary outcomes (4)
Acute gastrointestinal (GI) toxicity
RTOG scale
Measured: Within 12 weeks of treatment completion
Late GI and GU toxicity
RTOG scale
Measured: From 12 weeks until study completion
Patient reported outcomes i.e. IPSS, IIEF-5 and EQ5-D
IPSS, IIEF-5 and EQ5-D
Measured: Baseline, 12 weeks, 12 months and 6 monthly to 5 years
Biochemical relapse-free survival
PSA will be measured 3-6 monthly during study
Measured: Measured at 12 weeks after completion of treatment and 3-6 monthly to 5 years thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145494
- Sponsor's protocol ID
- 13/LO/0109
- Other IDs
- CCR 3923
- Acronym
- SPARC
- Status last verified
- May 2014
- First submitted
- 4 Jun 2013
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Prostate Augmented Radiotherapy With Cyberknife
- ClinicalTrials.gov ID
- NCT02145494
- Acronym / sponsor ID
- SPARC / 13/LO/0109
- Conditions
- Prostate Cancer
- Keywords
- SBRT (stereotactic body radiotherapy), Focal boost, Prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: RadiotherapyRadiotherapy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- PSA 20-40
- Gleason grade 4+3 or higher
- Stage T3a
Key exclusion criteria (3 listed)
- Nodal or metastatic disease
- PSA>40
- Stage T3b or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyAlso: CyberknifeStereotactic 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. | Radiation | Treatment |
Primary outcome
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.
4 secondary outcomes
Acute gastrointestinal (GI) toxicity
Time frame: Within 12 weeks of treatment completion
Late GI and GU toxicity
Time frame: 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
Biochemical relapse-free survival
Time frame: Measured at 12 weeks after completion of treatment and 3-6 monthly to 5 years thereafter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas J van As, FRCR contact
Daniel R Henderson, FRCR contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy in people with Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas J van As, FRCR (02078118336), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute genitourinary(GU) toxicity (time frame: Maximal recorded toxicity within the acute toxicity period (up to 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014; AzTrials last refreshed its copy on 30 Oct 2026.