Clinical Trial

Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy

Study acronym: AFFIRM
Not Yet Recruiting Phase 2
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Record status
This record was last updated November 7, 2022 (before its estimated July 1, 2024 completion). Its status may not reflect the trial's current state.
Summary
The AFFIRM trial tests the safety and clinical feasibility of MR-guided hypofractionated focal boost radiotherapy for patients with locally advanced prostate cancer. External beam radiotherapy combined with androgen deprivation therapy is considered as the treatment of choice for patients with locally advanced non-metastatic prostate cancer with seminal vesicle invasion.The long-term results of the multicentre phase III study (FLAME trial) showed that addition of an isotoxic focal boost to the intraprostatic lesion improves biochemical disease free survival in intermediate to high-risk patients without impacting toxicity and quality of life. This focal boost strategy is now proven for a conventional fractionation scheme (35 fractions). The current trend in radiotherapy for prostate cancer is (extreme) hypofractionation, reducing the number of fractions. For locally advanced prostate cancer, however, the data on extreme hypofractionation are scarce.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-05-12; most recent amendment 2022-11-03.
Trial Details
NCT Number NCT05373316
Lead Sponsor Radboud University Medical Center
Conditions Prostate Cancer, Prostate Neoplasm
Enrollment 95 participants
Start Date 2022-12-01
Primary Completion 2024-07-01 (estimated)
Study Completion 2029-07-01 (estimated)
Updated on ClinicalTrials.gov 2022-11-07