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Search / Trial NCT01168479

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 06, 2025

Completed

Keywords

Prostate Cancer External Beam Radiotherapy Dose Escalation Dose Painting 95 Gy In 35 Fractions Mri Flame

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.

Locations

Utrecht, , Netherlands

Leuven, Vlaans Brabant, Belgium

Nijmegen, Gelderland, Netherlands

Amsterdam, Noord Holland, Netherlands

Patients applied

0 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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