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.
Men aged 18 years or older with histologically proven prostate carcinoma
Imaging stage T3b (as defined on mpMRI) N0M0
Intraprostatic lesion visible on MRI
Capable of giving informed consent
History of radiotherapy to the pelvis or transurethral resection of the prostate (TURP)
Contraindications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrophobia
Absence of pre-treatment PSMA PET CT
WHO performance score > 2
Single group
Ultrahypofractionated MR-guided radiotherapy boost
RadiationExternal beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MRI.
Acute gastrointestinal and genitourinary toxicity
Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Acute toxicity is defined as toxicity occurring within 90 days after the first radiation treatment (e.g. 60 days after completion of the radiation treatment).
Late GI and GU toxicity (CTCAE v5.0)
assessed between 90 days and up to 5 years after the first radiation treatment
Quality of life
using the EORTC QLQ-C30 questionnaires
Quality of life
using the EORTC QLQ-PR25 questionnaires
Biochemical disease free survival
measuring the PSA concentration using the Phoenix definition for biochemical recurrence
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