Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER): A Two-part Phase 2/3 Trial

Phase 1

Recruiting

• Conditions: Prostate cancer; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-501551-90-00
• Lead Sponsor: Gasthuiszusters Antwerpen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-04
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 493

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified