Clinical Trial

Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0

Active, Not Recruiting Phase 2
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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).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2019-08-02; most recent amendment 2023-11-30.
Status change: Recruiting → Active, Not Recruiting 2022-06-07
Status change: Active, Not Recruiting → Recruiting 2021-01-04
Status change: Not Yet Recruiting → Active, Not Recruiting 2020-04-30
Trial Details
NCT Number NCT04045717
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Collaborators: The Netherlands Cancer Institute, Radboud University Medical Center, Kom Op Tegen Kanker
Conditions Prostate Adenocarcinoma, Prostate Cancer, Prostate Neoplasm
Enrollment 124 participants
Start Date 2020-04-10
Primary Completion 2022-06-01 (estimated)
Study Completion 2032-02-16 (estimated)
Updated on ClinicalTrials.gov 2023-12-01