NCT Number: NCT05373316
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.
Trial opening soon.
Get Notified18 year–100 year
Male
Interventional
Phase 2
Radboudumc, Nijmegen, Gelderland, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
External 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.
Time frame: 90 days after start of treatment
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).
Time frame: from 90 days after start of treatment up to 5 years
assessed between 90 days and up to 5 years after the first radiation treatment
Time frame: from baseline up to 5 years after completion of treatment
using the EORTC QLQ-C30 questionnaires
Time frame: from baseline up to 5 years after completion of treatment
using the EORTC QLQ-PR25 questionnaires
Time frame: up to 5 years after completion of treatment
measuring the PSA concentration using the Phoenix definition for biochemical recurrence
Time frame: up to 5 years after completion of treatment
Time frame: up to 5 years after completion of treatment
Time frame: up to 5 years after completion of treatment
Contact information is provided by the study sponsor or research team.
Casper Reijnen, MD, PhD
CONTACT
Linda Kerkmeijer, MD, PhD
CONTACT
Radboud University Medical Center
Other
Acronym: AFFIRM
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