CTIS2022-501551-90-00
Recruiting
Phase 1
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER): A Two-part Phase 2/3 Trial - CTO21042GZA
Gasthuiszusters Antwerpen0 sites493 target enrollmentJuly 4, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prostate cancer
- Sponsor
- Gasthuiszusters Antwerpen
- Enrollment
- 493
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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), Prior pelvic radiotherapy, Prior local therapy for PCa, Prior systemic therapy for PCa
Outcomes
Primary Outcomes
Not specified
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