Clinical trial NCT06282588: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers
Official title: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER): A Two-part Phase 2/ 3 Trial
Conditions: Prostate Cancer
Summary: 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.
Interventions:
description: 2x300 mg tablets twice daily, for up to 96 weeks
name: Darolutamide
other_name: BAY1841788
Nubeqa
type: Drug
description: 2x300 mg tablets twice daily, for up to 96 weeks
name: Darolutamide matched placebo
other_name: BAY1841788 matched placebo
type: Drug
description: Preferred regimens: 60 to 62 Gy delivered in 20 fractions of 3.0 to 3.1Gy per fraction; 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction, 2-3 fractions per week
name: Radiotherapy
type: Radiation
description: 3.6 mg, subcutaneous use
name: Zoladex 3.6Mg Implant
other_name: Goserelin acetate 3.6 mg
type: Drug
description: 10.8 mg, subcutaneous use
name: Zoladex LA
other_name: Goserelin acetate 10.8 mg
type: Drug
description: 22.5 mg, intramusculair injection
name: Decapeptyl sustained release 22.5 mg
other_name: Triptorelin 11.25 mg
type: Drug
description: 11.25 mg, intramusculair injection
name: Decapeptyl sustained release 11.25 mg
other_name: Triptorelin 11.25 mg
type: Drug
description: 45 mg, subcutaneous use
name: Depo-Eligard 45 mg
other_name: Leuprorelin acetate 45 mg
type: Drug
description: 22.5 mg, subcutaneous use
name: Depo-Eligard 22.5 mg
other_name: Leuprorelin acetate 22.5 mg
type: Drug
description: 7.5 mg, subcutaneous use
name: Depo-Eligard 7.5 mg
other_name: Leuprorelin acetate 7.5 mg
type: Drug
description: 120 mg, subcutaneous use
name: Firmagon 120 MG Injection
other_name: Degarelix 40 mg
type: Drug
description: 80 mg, subcutaneous use
name: Firmagon 80 MG Injection
other_name: Degarelix 20 mg
type: Drug
description: 75 mg per square m, IV infusion
name: Docetaxel
other_name: Taxotere
type: Drug
Study arms:
design_group_description: Darolutamide for up to 96 weeks (24 months) and primary SOC RT
design_group_title: Phase 2 Open Label
design_group_type: Experimental
design_group_description: Darolutamide + LHRHA for up to 96 weeks (24 months) and primary SOC RT
design_group_title: Phase 3 Blinded Experimental
design_group_type: Experimental
design_group_description: Darolutamide matched placebo + LHRHA for up to 96 weeks (24 months) and primary SOC RT
design_group_title: Phase 3 Blinded Comparator
design_group_type: Placebo Comparator
Sponsor: Cancer Research UK
Collaborators: Veracyte, Inc.
Bayer AG
Drug name mappings:
name: 双羟萘酸曲普瑞林
lang: CN
name: Triptorelin Pamoate
lang: EN
name: 醋酸地加瑞克
lang: CN
name: Degarelix Acetate
lang: EN
name: デガレリクス酢酸塩
lang: JP
name: 达罗他胺
lang: CN
name: Darolutamide
lang: EN
name: ダロルタミド
lang: JP
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP
name: 醋酸亮丙瑞林
lang: CN
name: Leuprolide Acetate
lang: EN
name: リュープロレリン酢酸塩
lang: JP
name: 醋酸戈舍瑞林
lang: CN
name: Goserelin Acetate
lang: EN
name: ゴセレリン酢酸塩
lang: JP