Prostate Cancer Adenocarcinoma Clinical Trial
Official title:
Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer (Hypo-FLAME)
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.
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.
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