NCT05373316Not yet recruitingPhase 2
Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
Source: ClinicalTrials.gov · Last updated 7 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 95 (estimated)
- First submitted
- 5 May 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT05373316
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 95
- From 1 Dec 2022 to the primary completion date, 1 Jul 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of radiotherapy to the pelvis or transurethral resection of the prostate (TURP)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.