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AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
What is being tested?
Enzalutamide Oral Capsule, Abiraterone Oral Tablet and Carboplatin
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
Are there results?
Not yet: the study is under way

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
Show all 11Show fewer
  • 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.

Berit Larsson, MSc contact

+46 8 52482576

berit.larsson@ki.se

Henrik Grönberg, Professor contact

+46 70 3411356

Henrik.gronberg@ki.se

32 sites in 4 countries

Sweden13 sites, 13 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

    Recruiting

Other trials in Sweden

Belgium12 sites, 12 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.

    Recruiting

  • AZ Jan Palfijn Ziekenhuis

    Ghent

    Bram De Laere, PhD, bramdlae.DeLaere@ugent.be

    Caroline Verbaeys, MD, PhD

    Not yet 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

    Recruiting

Other trials in Belgium

Norway5 sites, 5 recruiting

  • Ålesund Sjukehus

    Ålesund

    Berit Larsson, MSc, berit.larsson@ki.se

    Bjorg Y Aksnessaether, MD PhD

    Not yet 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

    Recruiting

  • Universitetssykehuset Nord-Norge Tromsö

    Tromsø

    Berit Larsson, MSc, berit.larsson@ki.se

    Hege S Haugnes, Prof, dr

    Not yet recruiting

Other trials in Norway

Switzerland2 sites, 2 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

    Recruiting

Other trials in Switzerland

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.

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 groups in NCT03903835
Study groupRoleWhat they receive
Control: Standard CareActive comparatorRandomization 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)ExperimentalAssignments 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 ARSiExperimentalPatients 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) inhibitorExperimentalDNA-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)ExperimentalSpecifically, 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) inhibitorExperimentalDNA-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 InhibitorExperimentalPatients 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: CarboplatinExperimentalOnly 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.

  1. 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.

  2. 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)

  1. Treatment response rate in mCRPC

    Treatment response is evaluated according to PCWG3 and RECIST 1.1

    Measured: 4 months after treatment start

  2. 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)

  3. Patient Reported Outcome Measures (PROM)

    QoL will be assessed using the EORTC QLQ-C30 instrument

    Measured: From enrolment to completion of study (60 months)

  4. 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)

  5. 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)

  6. 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.

  1. First posted4 Apr 2019
  2. Study start1 Feb 2019
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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)
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 40263079

  • De 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 39164518

  • De 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 35317973

  • Crippa 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Sweden, Belgium, Norway, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Berit Larsson, MSc (+46 8 52482576, berit.larsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) in mCRPC (time frame: Until progressive disease or 60 months from start of treatment, whatever occurs first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03903835, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.

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