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Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

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Trial Profile

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 May 2025

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At a glance

  • Drugs Bicalutamide (Primary) ; Buserelin (Primary) ; Darolutamide (Primary) ; Degarelix (Primary) ; Flutamide (Primary) ; Goserelin (Primary) ; Histrelin (Primary) ; Leuprorelin (Primary) ; Relugolix (Primary) ; Triptorelin (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Therapeutic Use
  • Acronyms GUIDANCE

Most Recent Events

  • 17 Mar 2025 Timeframe for primary endpoints has been changed. For Distant metastasis (DM) it is changed from ' From randomization to the detection of distant metastasis by conventional imaging, assessed up to 11 years' to 'From randomization to the detection of distant metastasis by conventional imaging, assessed up to 5 years'. For Metastasis-free survival (MFS) it is changed from 'upto 8 years' to 'upto 5 years'.
  • 17 Mar 2025 Planned End Date changed from 30 Apr 2037 to 11 Nov 2026.
  • 17 Mar 2025 Planned primary completion date changed from 30 Apr 2032 to 11 Nov 2026.

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