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Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0
Sponsor: Universitaire Ziekenhuizen KU Leuven
Summary
The hypo-FLAME 2.0 study is a multicenter phase II study (n=124) investigating the feasibility and safety of a reduction in the overall treatment time of radiotherapy for prostate cancer patients, making use of hypofractionated stereotactic body radiotherapy with focal boosting. We are looking for the optimal overall treatment time for this treatment strategy in the Hypo-FLAME 2.0 trial. In this study the total treatment time will be halved (15 days) in comparison with the total treatment time in the former hypo-FLAME trial (29 days) (NCT02853110).
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2020-04-10
Completion Date
2032-02-16
Last Updated
2023-12-01
Healthy Volunteers
No
Interventions
Hypo-FLAME 2.0 study
SBRT technique with 35 Gy in 5 fractions to the whole prostate gland and an additional simultaneously integrated focal boost to the tumor nodule(s) visible on MRI up to 50 Gy (overall treatment time (OTT) = 15 days).
Locations (3)
University Hospitals Leuven
Leuven, Belgium
The Netherlands Cancer Institute
Amsterdam, Netherlands
Radboudumc
Nijmegen, Netherlands