FLAME: Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer
Launched by UMC UTRECHT · Jul 22, 2010
Trial Information
Current as of June 29, 2025
Completed
Keywords
ClinConnect Summary
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 of care.
* Secondary study objectives: Establish and compare the rates of treatment-related toxicity, quality of life and disease-free survival.
Study design: Single blind prospective randomized controlled phase III trial.
Study population: Patients with intermediate or high risk adenocarcinoma of the prostate. Intermediate or high risk is defined according to the Ash et al. 2000 criteria as...
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Umc Utrecht
UMC Utrecht is a leading academic medical center in the Netherlands, renowned for its commitment to innovative research and high-quality patient care. As a prominent sponsor of clinical trials, UMC Utrecht leverages its extensive expertise in translational medicine and collaboration with various stakeholders to advance medical knowledge and improve therapeutic outcomes. The institution emphasizes ethical conduct and rigorous scientific standards, ensuring that all research activities contribute meaningfully to the global healthcare landscape. Through its robust clinical trial infrastructure, UMC Utrecht plays a vital role in facilitating the development of new treatments and enhancing patient wellbeing.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Utrecht, , Netherlands
Leuven, Vlaans Brabant, Belgium
Nijmegen, Gelderland, Netherlands
Amsterdam, Noord Holland, Netherlands
Patients applied
Trial Officials
Linda Kerkmeijer, MD, PhD
Principal Investigator
UMC Utrecht
Uulke van der Heide, PhD
Study Director
NKI
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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