Prostate Cancer, Prostate Neoplasm
Conditions
Brief 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.
Interventions
RADIATIONUltrahypofractionated MR-guided radiotherapy boost
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.
Sponsors
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute gastrointestinal and genitourinary toxicity | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | from baseline up to 5 years after completion of treatment | using the EORTC QLQ-C30 questionnaires |
| Biochemical disease free survival | up to 5 years after completion of treatment | measuring the PSA concentration using the Phoenix definition for biochemical recurrence |
| Late GI and GU toxicity (CTCAE v5.0) | 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 |
| Prostate cancer specific survival | up to 5 years after completion of treatment | — |
| Distant metastasis free survival | up to 5 years after completion of treatment | — |
| Overall survival | up to 5 years after completion of treatment | — |
Countries
Netherlands
Contacts
Primary ContactCasper Reijnen, MD, PhD
Backup ContactLinda Kerkmeijer, MD, PhD
Outcome results
None listed