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The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife

Sponsor
Royal Marsden NHS Foundation Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT02145494
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
66
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Radiotherapy
 Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Stereotactic Prostate Augmented Radiotherapy With Cyberknife
Study Start Date :
Jun 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Acute genitourinary(GU) toxicity [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.

    Secondary Outcome Measures

    1. Acute gastrointestinal (GI) toxicity [Within 12 weeks of treatment completion]

      RTOG scale

    2. Late GI and GU toxicity [From 12 weeks until study completion]

      RTOG scale

    3. Patient reported outcomes i.e. IPSS, IIEF-5 and EQ5-D [Baseline, 12 weeks, 12 months and 6 monthly to 5 years]

      IPSS, IIEF-5 and EQ5-D

    4. Biochemical relapse-free survival [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Marsden NHS Foundation trust London United Kingdom SW3 6JJ

    Sponsors and Collaborators

    • Royal Marsden NHS Foundation Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Royal Marsden NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT02145494
    Other Study ID Numbers:
    • 13/LO/0109
    • CCR 3923
    First Posted:
    May 23, 2014
    Last Update Posted:
    May 23, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Royal Marsden NHS Foundation Trust
    SBRT (stereotactic body radiotherapy)
    Focal boost
    Prostate
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of May 23, 2014