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Taking people in SpainPhase 2/3

Testing Treatment Plans Guided by Imaging Scans in High-Risk Prostate Cancer

Tests drug and radiation plans for men with high-risk prostate cancer, guided by PSMA scans.

Key facts

Who runs it
Ziekenhuis Aan De Stroom
Where
Barcelona, Madrid, Málaga, and Valencia, SpainSee the 5 sitesAlso in 1 other country, 11 sites
Registry title
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER): A Two-part Phase 2/3 Trial
Status
Recruiting
Phase
Phase 2/3
People taking part
493 people, planned
Started
13 Dec 2023
Expected to end
1 Sept 2030
Type of study
Interventional
Record updated
13 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult men with high-risk prostate cancer confirmed by tissue examination. They must be willing to have radiotherapy and long-term hormone treatment.

Age
18 years or older
Sex
Men only
Disease stage
High-risk prostate cancer: PSA > 20 ng/mL, or T-stage 3 or 4, or Gleason score 8-10. No clear spread outside the pelvic nodes on standard imaging.
Earlier treatment
No earlier pelvic radiotherapy, no earlier local treatment for prostate cancer and no earlier systemic treatment for prostate cancer.
Biomarker or test result
Willing to have the primary tumor sequenced to find the Decipher score. Willing to have a PSMA PET/CT scan.

Main reasons for not taking part

  • Clear spread (M1a, M1b or M1c) outside the pelvic nodes on bone scan, CT or MRI
  • Prostate cancer mainly of a non-adenocarcinoma type (sarcomatoid, spindle, neuroendocrine small cell, squamous cell or other)
  • Earlier pelvic radiotherapy
  • Earlier local treatment for prostate cancer
  • Earlier systemic treatment for prostate cancer

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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)

Where in Spain

Also in 1 other country, 11 sites

  • Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
  • Hospital Universitario 12 de OctubreMadrid, SpainTaking people
  • Hospital Universitario Ramón y CajalMadrid, SpainTaking people
  • Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
  • Hospital Universitario Y Politecnico La FeValencia, SpainTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER): A Two-part Phase 2/3 Trial
Plain-language title
Testing Treatment Plans Guided by Imaging Scans in High-Risk Prostate CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
13 July 2026