MR-guided focal boost radiotherapy tested in locally advanced prostate cancer
Tests a short course of MR-guided radiation boost in men with locally advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
Key facts
- Where
- Amsterdam and Nijmegen, NetherlandsSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT05373316, who can take part
Where in Netherlands
- Netherlands Cancer InstituteAmsterdam, NetherlandsNo longer taking part
- RadboudumcNijmegen, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Radboud University Medical Center
- Trial code
- NCT05373316
- Record updated
- 7 November 2022
- Original description
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.Read full original descriptionShow less
Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
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.
Inclusion: 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.
Exclusion: 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; International Prostate Symptom Score ≥ 15; PSA > 30; Prostate volume >100c.