Who is sponsoring NCT05373316?

NCT05373316 is sponsored by Radboud University Medical Center.

What drugs are being tested in NCT05373316?

Interventions in NCT05373316: Ultrahypofractionated MR-guided radiotherapy boost.

What condition does NCT05373316 study?

NCT05373316 studies Prostate Cancer, Prostate Neoplasm.

Is NCT05373316 still recruiting?

NCT05373316 is currently not yet recruiting. Last updated 7 November 2022.

Last reviewed 2022-11-07 · How we verify

NCT05373316: AFFIRM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Not yet recruiting Phase 2 Last updated 7 November 2022

What this trial tests

Phase 2 trial testing Ultrahypofractionated MR-guided radiotherapy boost in Prostate Cancer in 95 participants. Not yet recruiting.

Timeline

1 December 2022

Primary endpoint
1 July 2024

1 July 2029

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	95
Start date	1 December 2022
Primary completion	1 July 2024
Estimated completion	1 July 2029
Sites	2 locations across Netherlands

Drugs / interventions tested

Ultrahypofractionated MR-guided radiotherapy boost

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →
Prostate Neoplasm — all drugs for Prostate Neoplasm →

Sponsor

Radboud University Medical Center

Who can join

Adults 18 to 100, male only, with Prostate Cancer or Prostate Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy of Treatments for T3bN0M0 Prostate Cancer Patients: A Systematic Review and Meta-Analysis.
Reijnen C, Heemsbergen WD, Wever KE, Panneflek A, et al · · 2025 · PMID 40719409 · DOI 10.1002/pros.70024
Adaptive magnetic resonance image guided radiation for intact localized prostate cancer how to optimally test a rapidly emerging technology.
Hall WA, Kishan AU, Hall E, Nagar H, et al · · 2022 · PMID 36132128 · DOI 10.3389/fonc.2022.962897

Verify or expand the search:

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other Radboud University Medical Center trials

Trials by the same sponsor.

NCT07485569 — Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial · Phase 1 · not yet recruiting
NCT07514325 — MR-guided Adaptive Stereotactic Radiotherapy for Endometrial Cancer · NA · not yet recruiting
NCT07530263 — Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA) · Phase 1 · not yet recruiting
NCT07532577 — Intranasal Insulin to Prevent Intensive Care Unit Delirium · Phase 2, PHASE3 · not yet recruiting
NCT07504172 — Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05373316 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Radboud University Medical Center
Last refreshed: 7 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05373316.

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