Status:
NOT_YET_RECRUITING
Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
Lead Sponsor:
Radboud University Medical Center
Conditions:
Prostate Cancer
Prostate Neoplasm
Eligibility:
MALE
18-100 years
Phase:
PHASE2
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 combine...
Eligibility Criteria
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
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT05373316
Start Date
December 1 2022
End Date
July 1 2029
Last Update
November 7 2022
Active Locations (2)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525GA
2
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands, 1066CX