2022-501551-90-00RecruitingPhase 2/3
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER): A Two-part Phase 2/3 Trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Jul 2026
Brief summary (registry, in English)
Phase 3 Intensification study: To determine improvements in PSMA PET/ CT metastasis-free survival (ppMFS), where ppMFS is defined as the time from randomization to the date of at least 1 new PSMA-PET-positive distant lesion as compared to baseline or date of death from any cause Phase 2 De-intensification study: To determine improvements in Quality of Life indices and effectiveness of up to 96 weeks (24 months) of darolutamide plus SOC RT as an alternative to standard treatment (24 months ADT [LHRHA] plus SOC RT) or standard treatment with ADT plus darolutamide.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 493 (estimated)
- First submitted
- 4 Jul 2023
- Start date
- 13 Dec 2023
- Lead sponsor
- Ziekenhuis Aan De Stroom
- Diseases
- Prostate cancer
- EU CT number
- 2022-501551-90-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 493
- 16 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiotherapy
- Prior local therapy for PCa
- Prior systemic therapy for PCa
Other illness
- Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e., bone scan, CT scan, MRI)
Other
- PCa with predominant non-adenocarcinoma features (sarcomatoid or spindle or neuroendocrine small cell or squamous cell components or other non-adenocarcinoma)
Who the study is looking for
- Histopathology-proven PCa
- High-risk disease as any of the following factors: PSA > 20 ng/mL or T-stage 3 or 4 or Gleason score 8-10
- An Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
- Willingness to undergo a PSMA PET/ CT with or without contrast.
- Willingness to have their primary tumor sequenced for determination of Decipher score
- Willingness to undergo SOC RT and long-term ADT (treatment with darolutamide and/ or LHRHA)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZORG | Aalst | Belgium | Recruiting |
| Institut Jules Bordet | Anderlecht | Belgium | Recruiting |
| Ziekenhuis Aan De Stroom | Antwerp | Belgium | Recruiting |
| Az St-Jan Brugge-Oostende A.V. | Brugge | Belgium | Recruiting |
| Universitair Ziekenhuis Gent | Gent | Belgium | Recruiting |
| Algemeen Ziekenhuis Groeninge | Kortrijk | Belgium | Recruiting |
| Chu Helora | La Louvière | Belgium | Recruiting |
| CHU de Liège | Liège | Belgium | Recruiting |
| AZ Delta | Roeselare | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Vitaz | Sint-Niklaas | Belgium | Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria | Málaga | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.