FLAME: Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer
- 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:
- One (intermediate-risk) or more (high-risk) factors: T2, or Gleasonscore=7, or iPSA
- One or more (high-risk) factors: T3, or Gleasonscore >7, or iPSA >20 ng/mL
Intervention: The standard arm receives the current gold standard, namely 77Gy to the
prostate in 35 fractions of 2.2 Gy, 5 times per week. In the experimental arm patients
receive in addition to the current gold standard of 77 Gy to the prostate an integrated
boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions
of 2.7 Gy, 5 times per week.
Main study endpoint: To decrease the five-year biochemical relapse rate with at least 10%.
Nature and extent of the burden and risks associated with participation, benefit and group
Patients will have to fill in a quality of life questionnaire before and after the
radiotherapy treatments. The risk associated with the increased dose to the macroscopic
tumour is an increase of toxicity and a reduction of quality of life.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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.
PSA relapse is defined by the Phoenix definition (2005) as nadir +2ng/ml.
Every six months for 10 years
Marco van Vulpen, MD, PhD
Netherlands: Medical Ethics Review Committee (METC)