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NCT06116019: ART-02
Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)
trial testing Online adaptive radiation therapy in Prostate Cancer in 649 participants. Currently enrolling.
9 October 2026
Quick facts
| Lead sponsor | Charite University, Berlin, Germany |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 649 |
| Start date | 11 October 2023 |
| Primary completion | 9 October 2026 |
| Estimated completion | 9 October 2027 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Online adaptive radiation therapy
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
- Head and Neck Cancer — all drugs for Head and Neck Cancer →
- NSCLC — all drugs for NSCLC →
- SCLC — all drugs for SCLC →
Sponsor
Charite University, Berlin, Germany
Who can join
18 and older, any sex, with Prostate Cancer or Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study focuses on the scientific and clinical evaluation of online adaptive radiotherapy (ART) using the Varian/SHS ETHOS treatment system. In this study, radiation treatment plans are dynamically adjusted on a daily basis over several weeks of therapy to account for anatomical shifts in either the tumour or adjacent normal tissue - a capability that has been difficult to achieve due to technical limitations. With the ETHOS accelerator, such real-time adjustments can be made based on cone beam computed tomography (CBCT). This is a prospective observational study with the primary objective of investigating the feasibility and acceptability of performing ART with ETHOS for different tumour entities. The study will also evaluate the feasibility of integrating multi-parametric data sets into the ART workflow, such as standardised electronic feedback on treatment toxicity from both patients (ePROMS) and physicians (ePRT).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Optimizing Workflow for Cone Beam Computed Tomography-Based Online Adaptive Radiation Therapy Toward Reduced Physician Involvement.
Kalinauskaite G, Künzel LA, Kluge A, Rubarth K, et al · · 2025 · cited 4× · PMID 40927651 · DOI 10.1016/j.adro.2025.101874 -
Prospective controlled study comparing patient-reported outcomes after daily online adaptive radiotherapy or conventional IGRT in patients with prostate cancer.
Kalinauskaite G, Künzel LA, Rubarth K, Nguyen T, et al · · 2026 · PMID 41492405 · DOI 10.1016/j.ctro.2025.101092
Verify or expand the search:
- PubMed search for NCT06116019
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Online adaptive radiation therapy
Trials testing the same drug.
- NCT05911789 — Online Adaptive Radiation Therapy for Rectal Cancer · Phase 1, PHASE2 · unknown
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 Charite University, Berlin, Germany trials
Trials by the same sponsor.
- NCT07486167 — Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congeni · Phase 1, PHASE2 · not yet recruiting
- NCT07476729 — International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020) · Phase 3 · not yet recruiting
- NCT07503054 — Ovarian Cancer Screening and AI · NA · not yet recruiting
- NCT07529197 — Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious ME/CFS · recruiting
- NCT07388693 — Feasibility of Integrating Olfactory Stimuli Into Virtual Reality Cue Exposure for Patients With Alcohol Dependence · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06116019 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Charite University, Berlin, Germany
- Last refreshed: 3 November 2023
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/NCT06116019.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing