OncoMatch/Clinical Trials/NCT06282588
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers
Is NCT06282588 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments for prostate cancer.
Treatment: Darolutamide · Zoladex 3.6Mg Implant · Zoladex LA · Decapeptyl sustained release 22.5 mg · Decapeptyl sustained release 11.25 mg · Depo-Eligard 45 mg · Depo-Eligard 22.5 mg · Depo-Eligard 7.5 mg · Firmagon 120 MG · Firmagon 80 MG · Docetaxel — This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead of standard imaging which is limited by lower sensitivity and specificity. The hypothesis for the study is that treatment intensification based on a positive PSMA PET/ CT scan or Decipher high score (\> 0.85) improves time to new metastases detected on PSMA PET/ CT in high-risk PCa. In patients who are PSMA PET/ CT negative with a low/ intermediate Decipher score (≤ 0.85), it is hypothesized that treatment de-intensification will improve patient quality of life while maintaining a good oncological outcome. The study will be conducted at multiple centers across Europe. Participation in the study will comprise a screening period, where the screening assessments must be completed before subjects are enrolled and randomized (only for Phase 3 subjects). Eligible, consenting subjects will then undergo treatment according to their assigned study phase and treatment group, to occur over up to 96 weeks (24 months) with a post-treatment follow-up period to monitor safety and efficacy. The study will be closed when 96 events have been registered for the primary endpoint, which is expected to be at 7-8 years from the time of randomization of the first subject.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Allowed: FOLH1 PSMA PET/CT imaging positive (E-PMSA score 4 or 5)
Subjects who are PSMA PET/ CT positive for at least one regional or distant (extra-pelvic) lesion at screening (PSMA PET scans will be assessed as described in the study imaging manual), will be eligible to be randomized to either arm of the Phase 3 study. A lesion is considered positive if it has a E-PMSA score of 4 or 5.
Allowed: FOLH1 PSMA PET/CT imaging negative for regional or distant lesions
subjects who are PSMA PET/ CT negative for regional or distant lesions at screening (PSMA PET scans will be assessed as described in the study imaging manual), will be eligible for inclusion in either the Phase 3 study (if a high [> 0.85] Decipher score is confirmed) or the non-randomized Phase 2 study (if a low/ intermediate [≤ 0.85] Decipher score is confirmed).
Disease stage
Required: Stage CN1
Grade: Gleason score 8-10 (Gleason)
High-risk locally advanced disease is defined as any of the following factors: PSA > 20 ng/mL OR T-stage 3 or 4 OR Gleason score 8-10 OR cN1. Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: pelvic radiotherapy
Prior pelvic radiotherapy
Cannot have received: local therapy for PCa (radical prostatectomy, high-intensity focused ultrasound (HIFU), cryotherapy)
Exception: Subjects with previous transurethral resection of the prostate (TURP) or Millin prostatectomy are eligible for participation
Prior local therapy for PCa (e.g., radical prostatectomy, high-intensity focused ultrasound [HIFU], cryotherapy). Subjects with previous transurethral resection of the prostate (TURP) or Millin prostatectomy are eligible for participation
Cannot have received: systemic therapy for PCa
Exception: except for patients with a positive PSMA PET/ CT staging with ADT started no more than 4 weeks prior to randomization
Prior systemic therapy for PCa, except for patients with a positive PSMA PET/ CT staging with ADT started no more than 4 weeks prior to randomization.
Lab requirements
Blood counts
Hemoglobin ≥ 100 g/L, white cell count (WCC) ≥ 4.0 x 10^9/L, absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L and platelets > 100 x 10^9/L
Kidney function
calculated creatinine clearance > 30 mL/min (Cockroft-Gault)
Liver function
ALT < 2 x upper limit of normal (ULN) and total bilirubin < 1.5 x ULN, (or if total bilirubin is between 1.5 to 2 x ULN, they must have a normal conjugated bilirubin)
Adequate organ function determined by the following local laboratory values: Adequate bone marrow function: Hemoglobin ≥ 100 g/L, white cell count (WCC) ≥ 4.0 x 10^9/L, absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L and platelets > 100 x 10^9/L; Adequate renal function: calculated creatinine clearance > 30 mL/min (Cockroft-Gault); Adequate liver function: ALT < 2 x upper limit of normal (ULN) and total bilirubin < 1.5 x ULN, (or if total bilirubin is between 1.5 to 2 x ULN, they must have a normal conjugated bilirubin); Testosterone levels > 50 ng/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify