Addition of a Focal boost In external beam Radiotherapy for locally advanced prostate cancer by online adaptive MR-guided radiotherapy (AFFIRM trial)
Phase 2
Recruiting
- Conditions
- prostate cancerprostate carcinoma1003859710036958
- Registration Number
- NL-OMON53565
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 95
Inclusion Criteria
Men aged 18 years or older with histogically proven prostate carcinoma
Imaging stage T3b (as defined on mpMRI) N0M0
Intraprostatic lesion visible on MRI
Capable of giving informed consent
Participation in the MOMENTUM dataregistry
Exclusion Criteria
History of radiotherapy to the pelvis or transurethral resection of the
prostate (TURP)
Contraindications for MRI according to the guidelines of the Department of
Radiology, inability to lay on a treatment table for 45-60 minutes or severe
claustrophobia
Absence of pretreatment PSMA PET CT
WHO performance score > 2
International Prostate Symptom Score >= 15
PSA > 30
Prostate volume >100cc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is acute gastrointestinal and genitourinary toxicity,<br /><br>scored by the Common Terminology Criteria Adverse Events version 5.0. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are late gastrointestinal and genitourinary toxicity,<br /><br>quality of life and biochemical disease free survival defined by the Phoenix<br /><br>consensus definition </p><br>