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Addition of a Focal boost In external beam Radiotherapy for locally advanced prostate cancer by online adaptive MR-guided radiotherapy (AFFIRM trial)

Addition of a Focal boost In external beam Radiotherapy for locally advanced prostate cancer by online adaptive MR-guided radiotherapy (AFFIRM trial) - AFFIRM trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53565
Enrollment
95
Registered
2022-06-23
Start date
2022-11-28
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

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

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary endpoint is acute gastrointestinal and genitourinary toxicity, scored by the Common Terminology Criteria Adverse Events version 5.0.

Secondary

MeasureTime frame
Secondary endpoints are late gastrointestinal and genitourinary toxicity, quality of life and biochemical disease free survival defined by the Phoenix consensus definition

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)