Status:
COMPLETED
FLAME: Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer
Lead Sponsor:
UMC Utrecht
Conditions:
Prostate Cancer
Radiotherapy
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
Rationale: Dose escalation in external-beam irradiation has proven to benefit outcome in local prostate cancer. Randomized trials were performed up to doses of 78 Gy in 2 Gy fractions. Nevertheless, t...
Detailed Description
Objective: * Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard...
Eligibility Criteria
Inclusion
- Prostate cancer patients scheduled for external beam radiotherapy using IMRT and fiducial marker-based position verification
- Intermediate and high risk prostate cancer, defined by Ash et al. 2000, namely:
- One or more factors: T2, or Gleasonscore \>7, or iPSA \> 10 ng/mL
- WHO score 0-2
Exclusion
- Low risk prostate cancer, defined by Ash et al. 2000
- World Heath Organisation (WHO) score \>2
- International Prostate Symptom Score (IPSS) \>20
- If for any patient related reason an MRI cannot be performed
- If anticoagulation cannot be stopped temporarily regarding the implant of fiducial markers
- Previous prostatectomy (except from Trans Urethral Prostatectomy (TURP))
- TURP within 3 months from start treatment
- Previous pelvic irradiation
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
571 Patients enrolled
Trial Details
Trial ID
NCT01168479
Start Date
September 1 2009
End Date
January 1 2016
Last Update
June 2 2020
Active Locations (4)
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1
University Hospitals Leuven
Leuven, Vlaans-Brabant, Belgium, 3000
2
Radboud UMC
Nijmegen, Gelderland, Netherlands, 6500HB
3
NKI-AvL
Amsterdam, North Holland, Netherlands, 1066CX
4
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX