Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER): A Two-part Phase 2/3 Trial
Key facts
- Where
- Aalst, Anderlecht, Antwerp, Brugge, Gent, Kortrijk, La Louvière, Liège, Roeselare, Sint-Lambrechts-Woluwe és Sint-Niklaas, BelgiumSee the 11 sites
- Phase
- 2/3. fázis
Where in Belgium
- AZORGAalst, BelgiumTaking people
- Institut Jules BordetAnderlecht, BelgiumTaking people
- Ziekenhuis Aan De StroomAntwerp, BelgiumTaking people
- Az St-Jan Brugge-Oostende A.V.Brugge, BelgiumTaking people
- Universitair Ziekenhuis GentGent, BelgiumTaking people
- Algemeen Ziekenhuis GroeningeKortrijk, BelgiumTaking people
- Chu HeloraLa Louvière, BelgiumTaking people
- CHU de LiègeLiège, BelgiumTaking people
- AZ DeltaRoeselare, BelgiumTaking people
- Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumTaking people
- VitazSint-Niklaas, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ziekenhuis Aan De Stroom
- Trial code
- EU 2022-501551-90-00
- Record updated
- 2026. július 13.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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).
Exclusion: Prior pelvic radiotherapy; Prior local therapy for PCa; Prior systemic therapy for PCa; 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); PCa with predominant non-adenocarcinoma features (sarcomatoid or spindle or neuroendocrine small cell or squamous cell components or other non-adenocarcinoma).