ArticleTrials2020
The ProBio trial: molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer.
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03903835 (ProBio), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- A Systematic Review of Adaptive Seamless Clinical Trials for Late-Phase Oncology Development.Therapeutic innovation & regulatory science · 2024Pooled it
- Methodology and design of platform trials: a meta-epidemiological study.Journal of clinical epidemiology · 2023Pooled it
- Androgen receptor pathway inhibitors and taxanes in metastatic prostate cancer: an outcome-adaptive randomized platform trial.Nature medicine · 2024Trial
- Platinum-based chemotherapy in metastatic castration-resistant prostate cancer: a narrative review and dual stratification framework based on HRR genotype and aggressive-variant/neuroendocrine phenotype.International urology and nephrology · 2026Review
- Deep targeted sequencing of circulating tumor DNA to inform treatment in patients with metastatic castration-resistant prostate cancer.Journal of experimental & clinical cancer research : CR · 2025Article
- TAM Plasticity under androgen deprivation therapy and PARP inhibition in prostate cancer: a multi-omics perspective.Frontiers in immunology · 2025Review
- Emerging frontiers in androgen receptor research for prostate Cancer: insights from the 2nd international androgen receptor Symposium.Journal of experimental & clinical cancer research : CR · 2024Article
- Prediction of plasma ctDNA fraction and prognostic implications of liquid biopsy in advanced prostate cancer.Nature communications · 2024Article
- Flexible evaluation of surrogacy in platform studies.Biostatistics (Oxford, England) · 2023Article
- Treatment landscape and burden of disease in metastatic castration-resistant prostate cancer: systematic and structured literature reviews.Frontiers in oncology · 2023Review
- Article
- Detection of von Hippel-Lindau gene mutation in circulating cell-free DNA for clear cell renal cell carcinoma.Cancer science · 2021Article
- Clinical implications of genomic alterations in metastatic prostate cancer.Prostate cancer and prostatic diseases · 2021Review
- Resistance to second-generation androgen receptor antagonists in prostate cancer.Nature reviews. Urology · 2021Review
- Increased Pathway Complexity Is a Prognostic Biomarker in Metastatic Castration-Resistant Prostate Cancer.Cancers · 2021Article
- AZGP1 Protein Expression in Hormone-Naïve Advanced Prostate Cancer Treated with Primary Androgen Deprivation Therapy.Diagnostics (Basel, Switzerland) · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 8 institutions in 4 countries.
Funding
Abstract
backgroundMultiple 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.
methodsThe 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.
conclusionsThe ProBio design allows promising treatment-biomarker combinations to quickly graduate from the platform and be confirmed for rapid implementation in clinical care.
trial registrationClinicalTrials.gov Identifier NCT03903835. Date of registration: April 4, 2019. Status: Recruiting.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.