Metastatic Castration-resistant Prostate Cancer (mCRPC)Phase 3ProBioNCT03903835
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
A Phase 3 study testing Enzalutamide Oral Capsule, Abiraterone Oral Tablet and Carboplatin in people with Metastatic Castration-resistant Prostate Cancer (mCRPC) and Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by Karolinska Institutet at 32 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- What is being tested?
- Enzalutamide Oral Capsule, Abiraterone Oral Tablet and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 32 sitesin 4 countries
- Study dates
- 1 Feb 2019to Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man with histologically confirmed prostate adenocarcinoma, initiating systemic therapy for metastatic disease, encompassing newly diagnosed (i.e. de novo) hormone sensitive prostate cancer (mHSPC) or first-line castration resistant prostate cancer (mCRPC)
- Distant metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI
- Adequate health as assessed by the investigator to receive all available treatments in the trial
- ECOG/WHO (Eastern Cooperative Oncology Group/ World Health Organization) performance score 0-2
- Adequate organ and bone marrow function
- Albumin greater than or equal to 28 g/L
- Able to understand the patient information and sign written informed consent
Who cannot join
- Other malignancies within 5 years except non-melanoma skin cancer
- Within 6 months of randomization: myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke, TIA (transient ischemic attack), or congestive heart failure NYHA (New York Heart Association) class III or IV
- Uncontrolled hypertension
- Uncontrolled hypotension
- Received systemic therapy (with the exception of standard ADT) prior to study inclusion, for the CRPC indication
- Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results
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- Unable to comply with study procedures
- Current participation in another clinical trial that will be in conflict with the present study, administration of an investigational therapeutic or invasive surgical procedure within 28 days prior to study enrolment
- Patients who are unlikely to comply with the protocol
- Any condition or situation which, in the opinion of the investigator, would put the subject at risk, may confound study results, or interfere with the subjects participation in this study.
- Any medical condition that would make use of the study treatments contraindicated, according to the SmPC, e.g. significant heart or liver disease.
Trial locations and contacts
32 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 4 countries
Sweden13 sites, 13 recruiting
- Recruiting
Södra Alvsborgs sjukhus
Borås
Susanne Johansson, B.Sc., susanne.johansson@ki.se
Christine Jaredsson, MD, PhD
- Recruiting
Falu lasarett
Falun, Region Dalarna, 79182
Berit Larsson, MSc
berit.larsson@ki.se
- Recruiting
Länssjukhuset Ryhov - Onkologiska kliniken
Jönköping, 551 11
Berit Larsson, MSc, berit.larsson@ki.se
Linn Pettersson, MD, PhD
- Recruiting
Länssjukhuset
Kalmar, 392 44
Berit Larsson, MSc, berit.larsson@ki.se
Mats Andén, MD, PhD
- Recruiting
Centralsjukhuset Region Värmland
Karlstad, 651 85
Berit Larsson, MSc, berit.larsson@ki.se
Johan Sandzen, MD, PhD
- Recruiting
Universitetssjukhuset Örebro
Örebro
Susanne Johansson, B.Sc., susanne.johansson@ki.se
Jenny Kahlmeter Brandell, MD, PhD
- Recruiting
Karolinska University Hospital
Stockholm, 17176
Berit Larsson, MSc, berit.larsson@ki.se
Anders Ullén, MD, PhD
- Recruiting
Capio St.Görans Hospital
Stockholm
Henrik Grönberg, Professor, henrik.gronberg@capiostgoran.se
Berit Larsson, MSc, berit.larsson@ki.se
- Recruiting
Länssjukhuset Sundsvall Härnösand
Sundsvall, 851 86
Berit Larsson, MSc, berit.larsson@ki.se
Elin Jänes, MD PhD
- Recruiting
Norrlands Universitetssjukhus
Umeå, 90185
Berit Larsson, MSc, berit.larsson@ki.se
Camilla Thellenberg Karlsson, MD PhD
- Recruiting
Akademiska sjukhuset
Uppsala, 75185
Berit Larsson, MSc, berit.larsson@ki.se
Gunilla Enblad, Professor
- Recruiting
Hallands sjukhus Varberg
Varberg
Susanne Johansson, B.Sc., susanne.johansson@ki.se
Ingela Franck Lissbrant, MD, PhD
- Recruiting
Centrallasarettet Onkologkliniken
Vaxjo, 351 85
Berit Larsson, MSc, berit.larsson@ki.se
Martha Olsson, MD, PhD
Belgium12 sites, 12 recruiting
- Recruiting
OLV Ziekenhuis Aalst
Aalst
Bram De Laere, PhD, bramdlae.DeLaere@ugent.be
Peter Schatterman, MD
- Recruiting
GZA Sint-Augustinus
Antwerp
Bram De Laere, PhD, bramdlae.DeLaere@ugent.be
Michiel Strijbos, MD, PhD
- Recruiting
AZ Sint-Jan AV
Bruges, B-8000
Bram De Laere, PhD, bramdlae.DeLaere@ugent.be
Christophe Ghysel, MD
- Recruiting
AZ Sint-Lucas
Bruges
Bram De Laere, PhD, bramdlae.DeLaere@ugent.be
Daan De Maeseneer
- Recruiting
Ziekenhuis Oost-Limburg
Genk
Bram De Laere, PhD, bramdlae.DeLaere@ugent.be
Wendy De Roock, MD
- Recruiting
University Hospital Ghent
Ghent, B-9000
Bram De Laere, PhD, bramdlae.DeLaere@ugent.be
Piet Ost, Prof. dr.
- Not yet recruiting
AZ Jan Palfijn Ziekenhuis
Ghent
Bram De Laere, PhD, bramdlae.DeLaere@ugent.be
Caroline Verbaeys, MD, PhD
- Recruiting
Jessa ziekenhuis
Hasselt
Bram De Laere, PhD, bramdlae.DeLaere@ugent.be
Daisy Luyten, MD
- Recruiting
AZ Groeninge
Kortrijk
Bram De Laere, PhD, bramdlae.DeLaere@ugent.be
Siska Van Bruwaene
- Recruiting
University Hospital Luik
Liège
Bram De Laere, PhD, bramdlae.DeLaere@ugent.be
Brieuc Sautois, MD
- Recruiting
AZ Damiaan
Ostend
Bram De Laere, PhD, bramdlae.DeLaere@ugent.be
Jochen Darras, MD
- Recruiting
VITAZ
Sint-Niklaas
Bram De Laere, PhD, bramdlae.DeLaere@ugent.be
Els Everaert, MD, PhD
Norway5 sites, 5 recruiting
- Not yet recruiting
Ålesund Sjukehus
Ålesund
Berit Larsson, MSc, berit.larsson@ki.se
Bjorg Y Aksnessaether, MD PhD
- Recruiting
Kreftsenter Kristiansand
Kristiansand
Maria Persson, RN, maria.persson.3@ki.se
Christoph Müller, MD, PhD
- Recruiting
Akershus Universitetssykehus
Lørenskog
Berit Larsson, MSc
Jan Oldenburg, Prof. dr
- Recruiting
Stavanger Universitetssjukehus
Stavanger
Berit Larsson, MSc
Maria N Vigmostad, MD, PhD
- Not yet recruiting
Universitetssykehuset Nord-Norge Tromsö
Tromsø
Berit Larsson, MSc, berit.larsson@ki.se
Hege S Haugnes, Prof, dr
Switzerland2 sites, 2 recruiting
- Recruiting
St. Claraspital
Basel
Maria Persson, RN, maria.persson.3@ki.se
Arnoud Templeton, MD
- Recruiting
Universitätsspital Basel
Basel
Maria Persson, RN, maria.persson.3@ki.se
Ashkan Mortezavi, MD PhD
About this study
Official title: ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer
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.
Read the detailed description
ProBio is an outcome-adaptive, multi-arm, open-label, multiple assignment randomised biomarker driven platform trial in patients with metastatic hormone-sensitive and castration-resistant prostate cancer.
Patients will be randomised to control or experimental treatment class arms. Patients in the control arm will receive standard of care following national guidelines and will remain within the control arm throughout the course of the trial. Patients in the experimental arm will be randomised to a treatment class (consisting of one or multiple drugs) based on a biomarker signature. The biomarker signatures are defined as tumour properties or mutations in certain genes/pathways identified in the scientific literature as important in prostate cancer treatment response. The biomarker signatures are identified using a gene panel specifically designed for advanced prostate cancer.
Alterations in the following genes/pathways or combinations thereof constitute the biomarker signatures:
- Androgen receptor
- DNA-repair deficiency
- TP53
- TMPRSS2-ERG gene fusion
- PI3K pathway alterations
Patients in the experimental arm can be randomized to the following treatments classes:
for mHSPC
- AR signalling inhibitors (Abiraterone acetate, Enzalutamide, Apalutamide)
- Taxane-based chemotherapy in combination with ARSi (Docetaxel plus Abiraterone acetate, or Darolutamide)
- PolyADP Ribose Polymerase Inhibitors (Niraparib plus Abiraterone Acetate) for mCRPC
- AR signalling inhibitors (Enzalutamide, Abiraterone acetate)
- Poly ADP Ribose Polymerase Inhibitors (Niraparib plus Abiraterone acetate)
- Selective AKT Inhibitor (Capivasertib plus Docetaxel)
ProBio will use outcome-adaptive randomization, adapting the randomization based on the observed progression free survival (PFS) within biomarker signatures. Treatments will initially be assigned to patients based on the biomarker signatures for which that treatment is most likely to be effective. The trial will be analyzed within a Bayesian framework, which allows for calculations of the probability for each treatment that it is superior to standard of care within a given signature. Each experimental arm will be evaluated for efficacy relative to the control arm with the same biomarker signatures.
Participants and treating physicians will be blinded to ctDNA profile of each patient. The biomarker signatures will thus not influence treatment choice among controls (reflecting today's standard of care).
Further, ProBio will use the sequential multiple assignments trial (SMART) concept, where each patient who progresses within the trial will re-enter the trial and be re-assigned to another treatment based on the patient's current ctDNA profile. Patients will be withdrawn after in total maximal three randomized consecutive treatments after inclusion into the study.
The randomization probabilities within the experimental arm are defined in proportion to the probability that each treatment is superior to standard of care within a given biomarker signature, and therefore change as data accumulates in the trial and knowledge accumulates for what biomarker signatures and specific treatments that are more probable to be effective.
Trial results will be evaluated regularly by an independent data and safety monitoring board (DSMB). The DSMB will evaluate treatment-signature combinations with respect to:
- Graduation for superiority: A treatment-biomarker signature combination will be graduated from the trial if it has a Bayesian predictive probability of success in a future confirmatory phase III trial exceeding a pre-specified threshold (85%).
- Termination for futility: Treatment-biomarker signature combinations will be dropped from the trial for futility when success probabilities drop sufficiently low (less than 10% using a minimum of 20 patients assigned to the specific treatment-biomarker signature combination).
- Alternatively, if the maximum sample size of 300 and 150 patients (for mHSPC and mCRPC, respectively) assigned to a treatment biomarker signature is reached without graduation for superiority, assignments to that combination will end.
ProBio is a platform study. This means that new treatments and biomarker signatures can be added to the experimental arm in the future. This will be done after protocol amendments.
- Conditions
- Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Being tested
- Enzalutamide Oral Capsule, Abiraterone Oral Tablet, Carboplatin, Cabazitaxel 60 mg Solution for Injection, Docetaxel Injectable Solution
- Keywords
- mCRPC, mHSPC, cfDNA, Genomics, Liquid Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzalutamide Oral CapsuleDrug
Also called Xtandi
Detailed conditions for the use of the study treatments including dose and dosages are described in accordance with the marketing authorization in the SmPC (Summary of Product Characteristics).
Abiraterone Oral TabletDrug
Also called Zytiga
Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.
CarboplatinDrug
Carboplatin will be administered every 3rd week with an AUC (area under curve) = 5 with a dose calculated according to the Carboplatin AUC Dose calculation (Calvert formula):Dose (mg) = TargetAUC (mg/ml x min) x [GFR ml/min + 25].
Cabazitaxel 60 mg Solution for InjectionDrug
Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.
Docetaxel Injectable SolutionDrug
Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.
Radium Chloride Ra-223Drug
Also called Xofigo
Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.
Niraparib plus Abiraterone acetate plus PrednisoneDrug
Also called Akeega
Niraparib and Abiraterone acetate will be provided by Janssen and will be provided either as a fixed dose combination or as single agents. Detailed use of the study treatment including dose and dosages are described in the Investigator's brochures and SmPC.
Capivasertib plus DocetaxelDrug
Capivasertib is provided by AstraZeneca and will be given in combination with Docetaxel. All subjects will be given up to ten 21-day docetaxel cycles. All subjects will receive Capivasertib, which will be administered as tablets taken twice a day orally, on a 4 days on/3 days off continuous schedule, commencing cycle one, day 2, until disease progression.
ApalutamideDrug
Also called Erleada
Detailed conditions for the use of the study treatments including dose and dosages are described in accordance with the marketing authorization in the SmPC (Summary of Product Characteristics).
DarolutamideDrug
Also called Nubeqa
Detailed conditions for the use of the study treatments including dose and dosages are described in accordance with the marketing authorization in the SmPC (Summary of Product Characteristics).
| Study group | Role | What they receive |
|---|---|---|
| Control: Standard Care | Active comparator | Randomization between assignment to the control arm or the biomarker driven arm will be stratified on biomarker signatures, previous treatment, and fraction of ctDNA and will therefore occur after the results from the ctDNA profiling is obtained. Patients in the control arm will receive standard of care following national guidelines. Receives: Drug: Enzalutamide Oral Capsule; Drug: Abiraterone Oral Tablet; Drug: Cabazitaxel 60 mg Solution for Injection; Drug: Docetaxel Injectable Solution; Drug: Radium Chloride Ra-223; Drug: Apalutamide |
| Treatment 1 in mHSPC: AR signalling inhibitors (ARSi) | Experimental | Assignments to therapy in the biomarker driven arms will be done on the basis of the biomarker signature using the current information about the efficacy of the various regimens for that signature. Information from previous studies may be incorporated in the randomization at study onset if such reliable data exists. Specifically, patients with an intact androgen receptor (AR) and without TP53 mutations will have increased chance of being randomized to treatment with ARSi. Receives: Drug: Enzalutamide Oral Capsule; Drug: Abiraterone Oral Tablet; Drug: Apalutamide |
| Treatment 2 in mHSPC: taxane-based chemotherapy in combination with ARSi | Experimental | Patients with TP53 mutations and TMPRSS2-ERG gene fusions will have an increased chance of being randomised to treatment with chemotherapy plus an ARSi. Receives: Drug: Abiraterone Oral Tablet; Drug: Docetaxel Injectable Solution; Drug: Darolutamide |
| Treatment 3 in mHSPC: Poly ADP Ribose Polymerase (PARP) inhibitor | Experimental | DNA-repair deficient patients will have an increased chance of receiving PARP inhibitors at study onset. Receives: Drug: Niraparib plus Abiraterone acetate plus Prednisone |
| Treatment 1 in mCRPC: AR signalling inhibitors (ARSi) | Experimental | Specifically, patients with an intact androgen receptor (AR) and without TP53 mutations will have increased chance of being randomized to treatment with ARSi. Receives: Drug: Enzalutamide Oral Capsule; Drug: Abiraterone Oral Tablet |
| Treatment 2 in mCRPC: Poly ADP Ribose Polymerase (PARP) inhibitor | Experimental | DNA-repair deficient patients will have an increased chance of receiving PARP inhibitors at study onset. Receives: Drug: Niraparib plus Abiraterone acetate plus Prednisone |
| Treatment 3 in mCRPC: selective AKT Inhibitor | Experimental | Patients with alterations in the PI3K pathway will have an increased chance of receiving the combination treatment with Capivasertib plus Docetaxel. Receives: Drug: Capivasertib plus Docetaxel |
| Treatment 4 in mCRPC: Carboplatin | Experimental | Only patients with DNA-repair deficiency will be treated with Carboplatin as second line treatment in the castration-resistant phase of ProBio. Receives: Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) in mCRPC
Progression will be evaluated by the established international standards of the Prostate Cancer Working Group version 3 (PCWG3) and for soft tissue metastases (e.g. lung, liver and lymph nodes) according to the Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1).
Measured: Until progressive disease or 60 months from start of treatment, whatever occurs first.
Progression free survival (PFS) in mHSPC
Time to development of castration-resistance, as defined by EAU guidelines (biochemical progression or radiologic progression)
Measured: From date of treatment start until the date of first documentation of progression, assessed up to 60 months
Secondary outcomes (6)
Treatment response rate in mCRPC
Treatment response is evaluated according to PCWG3 and RECIST 1.1
Measured: 4 months after treatment start
Overall survival (OS)
OS is defined as time to death from any cause (overall and prostate cancer specific)
Measured: From enrolment to completion of study (60 months)
Patient Reported Outcome Measures (PROM)
QoL will be assessed using the EORTC QLQ-C30 instrument
Measured: From enrolment to completion of study (60 months)
Cost-effectiveness
Cost effectiveness will be assessed by using the EQ-5D-5L instrument to estimate health utilities. Treatment costs will be based on drug costs and reimbursement data.
Measured: From enrolment to completion of study (60 months)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Common Terminology Criteria for Adverse Events (CTCAE) developed and maintained by the US National Cancer Institute will be used to record adverse events
Measured: From enrolment to completion of study (60 months)
Treatment response rate in mHSPC
Response rates at 6 months on therapy will be evaluated by the established standards of EAU Guidelines
Measured: 6 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Feb 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- ProBio will use outcome-adaptive randomization, adapting the randomization based on the observed PFS within biomarker signatures. Treatments will initially be assigned to patients based on the biomarker signatures for which that treatment is most likely to be effective. The trial will be analysed within a Bayesian framework, which allows for calculations of the probability for each treatment that is superior to standard of care within a given signature. Each experimental arm will be evaluated for efficacy relative to the control arm with the same biomarker signatures.
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Kom Op Tegen Kanker, Janssen Pharmaceutica N.V., Belgium, AstraZeneca, Cancerfonden
- Responsible party
- Principal investigator, Henrik Grönberg, Karolinska Institutet
- Investigators
- Henrik Grönberg, Professor, Principal investigator, Karolinska InstitutetMartin Eklund, Professor, Study director, Karolinska InstitutetJohan Lindberg, PhD, Study director, Karolinska InstitutetPiet Ost, Professor, Principal investigator, University Hospital Ghent, BelgiumJan Oldenburg, Professor, Principal investigator, University Hospital, AkershusAshkan Mortezavi, MD, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903835
- Sponsor's protocol ID
- EudraCT No 2018-002350-78
- Acronym
- ProBio
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2019
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crippa A, Laere B, Discacciati A, Larsson B, Persson M, Johansson S, D'hondt S, Hjalm-Eriksson M, Pettersson L, Enblad G, Ullen A, Lumen N, Karlsson CT, Sandzen J, Janes E, Ghysel C, Olsson M, Sautois B, Schatteman P, Roock W, Bruwaene SV, Verbiene I, Darras J, Everaert E, Maeseneer D, Anden M, Strijbos M, Luyten D, Mortezavi A, Oldenburg J, Ost P, Lindberg J, Gronberg H, Eklund M; ProBio Investigators. Prognostic Value of the Circulating Tumor DNA Fraction in Metastatic Castration-resistant Prostate Cancer: Results from the ProBio Platform Trial. Eur Urol Oncol. 2025 Dec;8(6):1486-1495. doi: 10.1016/j.euo.2025.02.002. Epub 2025 Apr 21.
PubMed 40263079De Laere B, Crippa A, Discacciati A, Larsson B, Persson M, Johansson S, D'hondt S, Bergstrom R, Chellappa V, Mayrhofer M, Banijamali M, Kotsalaynen A, Schelstraete C, Vanwelkenhuyzen JP, Hjalm-Eriksson M, Pettersson L, Ullen A, Lumen N, Enblad G, Thellenberg Karlsson C, Janes E, Sandzen J, Schatteman P, Nyre Vigmostad M, Olsson M, Ghysel C, Sautois B, De Roock W, Van Bruwaene S, Anden M, Verbiene I, De Maeseneer D, Everaert E, Darras J, Aksnessether BY, Luyten D, Strijbos M, Mortezavi A, Oldenburg J, Ost P, Eklund M, Gronberg H, Lindberg J. Androgen receptor pathway inhibitors and taxanes in metastatic prostate cancer: an outcome-adaptive randomized platform trial. Nat Med. 2024 Nov;30(11):3291-3302. doi: 10.1038/s41591-024-03204-2. Epub 2024 Aug 20.
PubMed 39164518De Laere B, Crippa A, Discacciati A, Larsson B, Oldenburg J, Mortezavi A, Ost P, Eklund M, Lindberg J, Gronberg H; ProBio Investigators. Clinical Trial Protocol for ProBio: An Outcome-adaptive and Randomised Multiarm Biomarker-driven Study in Patients with Metastatic Prostate Cancer. Eur Urol Focus. 2022 Nov;8(6):1617-1621. doi: 10.1016/j.euf.2022.03.005. Epub 2022 Mar 19.
PubMed 35317973Crippa A, De Laere B, Discacciati A, Larsson B, Connor JT, Gabriel EE, Thellenberg C, Janes E, Enblad G, Ullen A, Hjalm-Eriksson M, Oldenburg J, Ost P, Lindberg J, Eklund M, Gronberg H. The ProBio trial: molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer. Trials. 2020 Jun 26;21(1):579. doi: 10.1186/s13063-020-04515-8.
PubMed 32586393