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Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer 2.0

StatusActive, Not Recruiting
PhasePhase 2
Started2020-04-10
View on ClinicalTrials.gov ↗

Amendment history

2023-11-30
Study Status v6
Re-verified, no change to tracked fields
2022-06-07
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2023-07-01→confirmed 2022-06-01
Completion date2033-05-16→2032-02-16
Study sitesdetails revised at 3 of 3 sites
2021-01-04
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 3 of 3 sites
2020-04-30
Not Yet Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Active, Not Recruiting
Primary completion date2023-03-01→2023-07-01
Completion date2030-01-15→2033-05-16
Start dateestimated 2020-01-15→confirmed 2020-04-10
Study sites0→3
2019-12-04
Study Status v2
Completion date2029-12-01→2030-01-15
Start date2019-12-01→2020-01-15
2019-09-09
Study Status v1
Primary completion date2022-05-01→2023-03-01
Completion date2029-09-01→2029-12-01
Start date2019-10-01→2019-12-01
2019-08-02
Original filing
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).
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