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Not yet recruiting NCT05373316

Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy

Phase II Interventional Prostate Cancer Prostate Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrahypofractionated MR-guided radiotherapy boost.
Who it may be relevant to
Registry conditions: Prostate Cancer, Prostate Neoplasm. Basic parameters: 18 years — 100 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Radiation Ultrahypofractionated 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.

Primary outcome measures

  • Acute gastrointestinal and genitourinary toxicity [Time frame: 90 days after start of treatment]
Secondary outcome measures (7)
  • Late GI and GU toxicity (CTCAE v5.0) [Time frame: from 90 days after start of treatment up to 5 years]
  • Quality of life [Time frame: from baseline up to 5 years after completion of treatment]
  • Quality of life [Time frame: from baseline up to 5 years after completion of treatment]
  • Biochemical disease free survival [Time frame: up to 5 years after completion of treatment]
  • Overall survival [Time frame: up to 5 years after completion of treatment]
  • Prostate cancer specific survival [Time frame: up to 5 years after completion of treatment]
  • Distant metastasis free survival [Time frame: up to 5 years after completion of treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 2 centers
  • Radboudumc — Nijmegen
  • Netherlands Cancer Institute — Amsterdam

Identifiers

NCT: NCT05373316 · NL79869.091.22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗