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The ProBio trial :
The ProBio trial : molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer
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- Crippa, Alessio (author)
- Karolinska Institutet
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- De Laere, Bram (author)
- Karolinska Institutet
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- Discacciati, Andrea (author)
- Karolinska Institutet
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- Larsson, Berit (author)
- Karolinska Institutet
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- Connor, Jason T. (author)
- Univ Cent Florida, Coll Med, Orlando, FL 32816 USA; Confluence Stat LLC, Orlando, FL, USA
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- Gabriel, Erin E. (author)
- Karolinska Institutet
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- Thellenberg-Karlsson, Camilla, 1972- (author)
- Umeå universitet,Onkologi,Umeå Univ, Dept Radiat Sci & Oncol, Umeå, Sweden
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- Jänes, Elin (author)
- Länssjukhuset Sundsvall Härnösand, Sundsvall, Sweden
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- Enblad, Gunilla (author)
- Uppsala universitet,Experimentell och klinisk onkologi
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- Ullen, Anders (author)
- Karolinska Institutet
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- Hjälm-Eriksson, Marie (author)
- Capio St Görans Hosp, Stockholm, Sweden
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- Oldenburg, Jan (author)
- Univ Oslo, Div Med, Oslo, Norway
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- Ost, Piet (author)
- Univ Ghent, Dept Radiotherapy & Expt Canc Res, Ghent, Belgium
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- Lindberg, Johan (author)
- Karolinska Institutet
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- Eklund, Martin (author)
- Karolinska Institutet
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- Grönberg, Henrik (author)
- Karolinska Institutet
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(creator_code:org_t)
- 2020-06-26
- 2020
- English.
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In: Trials. - : BioMed Central. - 1745-6215. ; 21:1
- Related links:
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https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
Subject headings
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- Background: Multiple therapies exist for patients with metastatic castration-resistant prostate cancer (mCRPC). However, their improvement on progression-free survival (PFS) remains modest, potentially explained by tumor molecular heterogeneity. Several prognostic molecular biomarkers have been identified for mCRPC that may have predictive potential to guide treatment selection and prolong PFS. We designed a platform trial to test this hypothesis.Methods: The Prostate-Biomarker (ProBio) study is a multi-center, outcome-adaptive, multi-arm, biomarker-driven platform trial for tailoring treatment decisions for men with mCRPC. Treatment decisions in the experimental arms are based on biomarker signatures defined as mutations in certain genes/pathways suggested in the scientific literature to be important for treatment response in mCRPC. The biomarker signatures are determined by targeted sequencing of circulating tumor and germline DNA using a panel specifically designed for mCRPC.Discussion: Patients are stratified based on the sequencing results and randomized to either current clinical practice (control), where the treating physician decides treatment, or to molecularly driven treatment selection based on the biomarker profile. Outcome-adaptive randomization is implemented to early identify promising treatments for a biomarker signature. Biomarker signature-treatment combinations graduate from the platform when they demonstrate 85% probability of improving PFS compared to the control arm. Graduated combinations are further evaluated in a seamless confirmatory trial with fixed randomization. The platform design allows for new drugs and biomarkers to be introduced in the study.Conclusions: The ProBio design allows promising treatment-biomarker combinations to quickly graduate from the platform and be confirmed for rapid implementation in clinical care.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- Clinical trial platform
- Genetic biomarker
- Prostate cancer
- Precision medicine
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Crippa, Alessio
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De Laere, Bram
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Discacciati, And ...
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Larsson, Berit
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Connor, Jason T.
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Gabriel, Erin E.
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Thellenberg-Karl ...
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Jänes, Elin
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Enblad, Gunilla
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Ullen, Anders
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Hjälm-Eriksson, ...
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Oldenburg, Jan
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Ost, Piet
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Lindberg, Johan
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Eklund, Martin
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Grönberg, Henrik
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Urology and Neph ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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Trials
- By the university
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Umeå University
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Uppsala University
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Karolinska Institutet