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ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

Study acronym: ProBio
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv9
  2. Primary endpoints: 1 to 2v8 Show 7 more changesShow less
    • Study sites: 26 to 32
    • Interventions: Abiraterone Oral Tablet [Zytiga] (Drug), Cabazitaxel 60 mg Solution for Injection (Drug), Carboplatin (Drug), Docetaxel Injectable Solution… to Abiraterone Oral Tablet (Drug), Apalutamide (Drug), Cabazitaxel 60 mg Solution for Injection (Drug), Capivasertib plus Docetaxel (Drug)…
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 5 to 6
    • Study description expanded, about 44 words
    • Collaborators: 3 to 5
    • Study arms: 7 to 8
  3. Study description expanded, about 31 words
    • Study title shortened, about 2 words
    v7
  4. Study sites: 23 to 26v6
  5. Interventions: Abiraterone Oral Tablet [Zytiga] (Drug), Cabazitaxel 60 mg Solution for Injection (Drug), Carboplatin (Drug), Docetaxel Injectable Solution… to Abiraterone Oral Tablet [Zytiga] (Drug), Cabazitaxel 60 mg Solution for Injection (Drug), Carboplatin (Drug), Docetaxel Injectable Solution…v5 Show 6 more changesShow less
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description expanded, about 6 words
    • Site details revised at 9 of 23 sites
    • Collaborators: 2 to 3
    • Study arms: 6 to 7
    • Eligibility criteria shortened, about 4 words
Show 3 earlier versionsHide 3 earlier versions
  1. Lead sponsor: Henrik Grönberg to Karolinska Institutet
    • Study sites: 5 to 23
    • Collaborators: 1 to 2
    v4
  2. Site details revised at 1 of 5 sitesv3
  3. Study sites: 2 to 5v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
ProBio is an international, outcome-adaptive, multi-arm, open-label, multiple assignment randomized biomarker driven platform trial in patients with metastatic prostate cancer. Patients will be randomized to control or experimental treatment arms. Patients in the control arm will receive standard of care following national guidelines. Patients in the experimental arm will be randomized to treatments based on a biomarker signature inferred from diagnostic tissue or liquid biopsy profiling. The predefined biomarker signatures are tumor properties or mutations in genes/pathways with previously demonstrated clinical validity (e.g. prognostic value or association with treatment response). The biomarker signatures are identified using a hybridisation capture gene panel specifically designed for prostate cancer.
Trial Details
NCT Number NCT03903835
Lead Sponsor Karolinska Institutet
Collaborators: The Swedish Research Council, Kom Op Tegen Kanker, Janssen Pharmaceutica N.V., Belgium, AstraZeneca, Cancerfonden
Conditions
(from sponsor)		 Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Enrollment 750 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov