Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer
Condition: Prostate Cancer Adenocarcinoma
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypo-FLAME study is a multicenter phase II study (n=100) to investigate whether a focal
      SBRT boost to the MRI-defined macroscopic tumor volume is feasible and associated with
      acceptable toxicity in addition to whole gland prostate SBRT.
    

Detailed description: 
      Rationale: Hypofractionation with a stereotactic body radiotherapy (SBRT) technique for
      prostate cancer produces excellent treatment outcome in terms of survival and toxicity and is
      much more convenient than the current fractionation scheme. Local recurrence occurs most
      frequently at the site of the primary or dominant tumor location prior to treatment.
      Therefore dose escalation at the site of the primary tumor may improve disease control.

      Objective: The main goal of this phase II study is to investigate whether a focal ablative
      SBRT boost to the macroscopic tumor is feasible and associated with acceptable toxicity in
      addition to whole gland prostate SBRT. The secondary objectives of this study are: late
      toxicity, quality of life (QoL) and biochemical disease free survival (bDFS). Furthermore,
      two side-studies are incorporated in this phase II study: 1) a weekly MRI will be performed
      to prepare for future MRI-guided (MR-linac) treatment without gold fiducial markers and 2)
      blood sampling for translational research (radiogenomics) and Biobank purposes.

      Study design: Prospective multicenter interventional study on whole gland prostate SBRT using
      MRI for focal boost in 100 consecutive intermediate or high risk prostate cancer patients.

      Study population: One hundred patients with histologically proven prostate adenocarcinoma
      with intermediate risk or high risk disease. Patients referred for external beam radiotherapy
      (EBRT) who fulfill the inclusion criteria and without any of the exclusion criteria will be
      included in the present trial after written informed consent.

      Intervention: Patients will be treated by external beam radiotherapy with a SBRT technique
      with 35 Gy in 5 weekly fractions and an additional simultaneously integrated focal boost to
      the tumor nodule(s) visible on MRI up to 50 Gy. In addition, patients will be asked to
      undergo 5 additional MRI scans (~15 min/scan) without contrast enhancement prior to each
      radiation session as well as blood sampling for translational research (radiogenomics) and
      Biobank purposes.

      Main study parameters/endpoints: The primary endpoints of this study are acute
      gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria
      for Adverse Events (CTCAE) version 4.0. Secondary endpoints are late GI and GU toxicity, QoL,
      and bDFS. Simultaneously, two side-studies will be performed, i.e. to prepare for MRI-guided
      radiotherapy and blood sampling for translational research (radiogenomics) and Biobank
      purposes.
    

Intervention name(s): Hypo-FLAME study
Intervention type(s): Radiation
Intervention description(s): SBRT technique with 35 Gy in 5 weekly fractions and an additional simultaneously integrated focal boost to the tumor nodule(s) visible on MRI up to 50 Gy. In addition, patients will be asked to undergo 5 additional MRI scans (~15 min/scan) without contrast enhancement prior to each radiation session as well as blood sampling for translational research (radiogenomics) and Biobank purposes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MRI, stereotactic body radiotherapy, hypofractionation