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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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Aug 2026

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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 Aug 2026 Planned End Date changed from 11 Nov 2026 to 11 Nov 2031.
  • 08 Apr 2026 Status changed from recruiting to active, no longer recruiting.
  • 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'.

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