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Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer

Study acronym: GUNS
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Apr 1, 2026 → Jun 1, 2027
See other at-risk trials from University of British Columbia

Record History

See every version on ClinicalTrials.gov ↗

  1. Site contacts updated at 2 of 9 sitesv14
  2. Primary and study completion pushed from Apr 1, 2026 to Jun 1, 2027v13 Show 5 more changesShow less
    • Trial arms changed: 6 → 8
    • Interventions: Abiraterone Acetate 250mg (Drug), Apalutamide 60mg Tab (Drug), Atezolizumab (Drug), Docetaxel (Drug), Niraparib 100mg Oral Capsule (Drug)… to Abiraterone Acetate 250mg (Drug), Apalutamide 60mg Tab (Drug), Atezolizumab (Drug), Capivasertib (Drug), Docetaxel (Drug), Niraparib 100mg…
    • Eligibility criteria expanded, about 78 words
    • Study description expanded, about 83 words
    • Study sites revised (9)
  3. Site details revised at 9 of 9 sitesv12
  4. Study sites: 8 to 9v11
  5. Study sites: 7 to 8v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 5 to 7v9
  2. Study sites: 4 to 5v8
  3. Study sites: 3 to 4v7
  4. Study sites: 2 to 3v6
  5. Study sites: 1 to 2v5
  6. Interventions: Abiraterone Acetate 250mg (Drug), Apalutamide 60mg Tab (Drug), Docetaxel (Drug), Niraparib 100mg Oral Capsule (Drug), Prednisone 5mg Tab… to Abiraterone Acetate 250mg (Drug), Apalutamide 60mg Tab (Drug), Atezolizumab (Drug), Docetaxel (Drug), Niraparib 100mg Oral Capsule (Drug)…
    • Study description expanded, about 28 words
    • Study arms: 5 to 6
    v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2021 to Sep 21, 2021
    • Study sites: 0 to 1
    v3
  8. Start date: Apr 1, 2021 to Jun 1, 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of this study is to see if providing an appropriate therapy based on the genomic testing of prostate tumour tissue will result in an improved clinical response. Each participant will be treated with 8 weeks of a luteinizing hormone-releasing hormone agonist (LHRHa) plus apalutamide (APA) while genome sequence characterization is being done. Participants with biopsy specimens deemed unevaluable for genomic testing will remain on LHRHa plus APA for an additional 16 weeks. Participants with evaluable tissue will be assigned to one of the open-label sub-studies on the basis of genomic profiling results. Within each group, they will be randomized to a specific treatment arm either LHRHa plus APA alone or adding abiraterone acetate and prednisone, docetaxel or niraparib. The study will evaluate the response rate and outcomes after radical prostatectomy in each arm of the trial.
Trial Details
NCT Number NCT04812366
Lead Sponsor University of British Columbia
Collaborators: Janssen Inc., University Health Network, Toronto
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 315 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov