Prostate Cancer (Adenocarcinoma)Phase 2PARIS-BIONCT07617272
Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore
A Phase 2 study testing Darolutamide and Radical prostatectomy in people with Prostate Cancer (Adenocarcinoma), run by Region Stockholm at 2 sites in Sweden.
Trial summary
The PARIS-BIO study evaluates whether a novel genomic biomarker, the PCAI ImmunoScore, can predict the response to neoadjuvant treatment with Darolutamide in patients with high-risk localized or locally advanced prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- Darolutamide and Radical prostatectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSweden
- Study dates
- 9 Nov 2025to Dec 2030
- Phase
- Phase 2
- 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
- Biopsy-confirmed high-risk prostate cancer defined as: Global ISUP score > 3 with any MRI PI-RADS score OR Global ISUP score = 3 with MRI PI-RADS score = 5
- Candidate for radical prostatectomy
- Clinical prostate MRI not older than 3 months at screening
- ECOG performance status score of 0 or 1
- Able to receive Darolutamide for 90-120 days
- Signed informed consent form
- Willingness to use contraception if sexually active
Who cannot join
- Metastatic (M1) or node-positive (N2) disease
- Prior treatment with androgen receptor antagonists
- Prior treatment with gonadotropin-releasing hormone (GnRH)
- History of prior systemic or local therapy for prostate cancer (including radiation and focal therapy)
- Major surgery <4 weeks prior to inclusion
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Johan Stranne, MD, Professor, +46(0)709558865, johan.stranne@vgregion.se
Johan Stranne, MD, Professor
- Recruiting
Karolinska University Hospital
Stockholm, SE-17176
Johan Björklund, MD, PhD, +46(0)709583113, johan.bjorklund@regionstockholm.se
Axel Möller, MD, PhD, +46(0)706271734, axel.moller@regionstockholm.se
About this study
Official title: PARIS-BIO - Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore in a Non-randomised Open Label Prospective Trial
The PARIS-BIO study evaluates whether a novel genomic biomarker, the PCAI ImmunoScore, can predict the response to neoadjuvant treatment with Darolutamide in patients with high-risk localized or locally advanced prostate cancer. Patients will receive Darolutamide monotherapy for 90-120 days prior to radical prostatectomy. The study aims to validate if the biomarker can identify patients who achieve Minimal Residual Disease (MRD) at the time of surgery.
Read the detailed description
High-risk prostate cancer patients are at risk for recurrence after local therapy. The presence of micro-metastatic disease, undetectable by conventional imaging, likely contributes to the poor prognosis. Neoadjuvant hormonal therapy, particularly with the advent of ARPIs like Darolutamide, has shown promise, but patient selection remains crucial for optimizing outcomes. This Phase II, single-arm, open-label trial investigates the predictive value of the PCAI ImmunoScore, a gene expression signature derived from diagnostic biopsies.
100 participants with high-risk prostate cancer scheduled for radical prostatectomy will be enrolled. They will receive Darolutamide (600 mg twice daily) for a period of 90 to 120 days. MRI imaging will be performed between day 90 and 120 prior to surgery. Radical prostatectomy is performed within the same window.
The primary analysis compares the pre-treatment biomarker score with the pathological response (Minimal Residual Disease) observed in the surgical specimen. Secondary analyses include MRI response, PSA kinetics, and patient-reported functional outcomes.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- Darolutamide, Radical prostatectomy
- Keywords
- Prostate cancer, Neoadjuvant, Darolutamide, ARPI, Prediction of treatment response
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarolutamideDrug
Also called Neoadjuvant ARPI, Nubeqa
Neoadjuvant Darolutamide alone (without ADT) 2x300 mg orally twice daily is given to all study subjects for 90-120 days prior to prostatectomy.
Radical prostatectomyProcedure or surgery
Also called RALP, RARP, Robot-assisted prostatectomy
Robot-assisted radical prostatectomy, with or without extirpation of pelvic lymph nodes according to clinician's choice in concordance with local guidelines
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Darolutamide | Experimental | All participants receive Darolutamide 600 mg orally twice daily for 90-120 days prior to radical prostatectomy Receives: Drug: Darolutamide; Procedure: Radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between the pre-treatment probability of treatment response given by PCAI ImmunoScore and the occurrence of minimal residual disease (MRD)
The primary outcome is the association between the pre-treatment PCAI ImmunoScore and the occurrence of minimal residual disease (MRD) after 90-120 days of neoadjuvant Darolutamide treatment. MRD is defined as < 0.05 cm3 residual tumour on final pathology after prostatectomy. The study endpoint MRD will be dichotomized into responder (if MRD is met) or non-responder (if MRD is not met) as input for the statistical data analysis. This classification (ground truth) will be tested in AUROC analysis against the calculated PCAI ImmunoScore-based probability p (0<p<1) of Darolutamide response. PCAI ImmunScore is calculated from RNA sequencing of tumor material from diagnostic (pre-treatment) biopsies. The collection of RNA and calculation of PCAI ImmunoScore will take place after the recruitment period. Sequencing will be performed in bulk once all samples have been collected. The objective is to assess the predictive value of the pre-treatment genomic biomarker for pathological response.
Measured: MRD is ascertained shortly after radical prostatectomy (day 90-120). PCAI ImmunoScore will be ascertained after bulk sequencing of all samples, tentatively 1 year after surgery of the 100th study subject. The association will be calculated thereafter.
Secondary outcomes (8)
The association between PCAI ImmunoScore and pathologic complete response (pCR)
The study endpoint pCR is defined as no residual tumour visible at final pathology and will be dichotomized into responder (if pCR is met) or non-responder (if pCR is not met) as input for the statistical data analysis. This classification (ground truth) will be tested in AUROC analysis against the calculated PCAI ImmunoScore-based probability p (0<p<1) (baseline model) of Darolutamide response. The extended model including the additional covariates will be tested equivalent to the baseline model.
Measured: pCR is ascertained shortly after radical prostatectomy (day 90-120). PCAI ImmunoScore will be ascertained after bulk sequencing of all samples, tentatively 1 year after surgery of the 100th study subject. The association will be calculated thereafter.
Pathological T-stage (pT-stage)
Staging of the tumor at final pathology
Measured: Pathological T-stage will be ascertained shortly after radical prostatectomy (day 90-120)
Residual tumor size
Measurement of the largest cross-sectional dimensions (mm) of residual tumor
Measured: At the time of radical prostatectomy (day 90-120)
PSA Kinetics
Change in blood PSA concentration (ng/ml) during treatment
Measured: Baseline, Day 30, Day 60, Day 90, and within 4 weeks after surgery
Hormonal side effects
Incidence and severity of adverse events assessed by CTCAE v5.0 and patient-reported quality-of-life using the 26-question questionnaire Expanded Prostate cancer Index Composite (EPIC-26), where lower scores indicate worse outcome
Measured: From baseline up to 12 months post-surgery
Patient-reported urinary continence
Assessment of pre-and post-treatment urinary function using the Swedish national questionnaires (electronic patient-reported outcome measurements -ePROM "Symtom- och biverkningsenkät" that all patients undergoing prostate cancer treatment in Sweden routinely are invited to answer), where urinary continence is assessed using the question "How many protective pads do you use daily due to urine leakage?" The reply alternatives are:
None Fewer than 1 per day About 1 per day About 2 per day About 3-4 per day About 5 or more per day
Measured: Pre-surgery (day 80-119), 3 months post-surgery, 12 months post-surgery
Patient-reported erectile function
Assessment of pre-and post-treatment erectile function using the Swedish national questionnaires (electronic patient-reported outcome measurements -ePROM "Symtom- och biverkningsenkät" that all patients undergoing prostate cancer treatment in Sweden routinely are invited to answer), where erectile function is assessed using the question "How would you describe your erection?" The reply alternatives are:
No noticeable filling or firmness Some filling, but not sufficient for full function Moderate firmness Full firmness
Measured: Pre-surgery (day 80-119), 3 months post-surgery, 12 months post-surgery
MRI tumor response
Change in tumor size and Extraprostatic Extension (EPE) score (Likert scale 1-5) on MRI compared to baseline MRI
Measured: Pre-surgery (day 90-120)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start9 Nov 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Sahlgrenska University Hospital, Philips Intellectual Property & Standards, OHMX.bio, European Union, Bayer
- Responsible party
- Sponsor
- Investigators
- Peter N Wiklund, MD, Professor, Principal investigator, Region Stockholm represented by Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617272
- Sponsor's protocol ID
- 5.1.1-2025-027483
- Other IDs
- 2025-520639-17-00, 2025
- Acronym
- PARIS-BIO
- Status last verified
- Nov 2025
- First submitted
- 12 Dec 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARIS-BIO - Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore in a Non-randomised Open Label Prospective Trial
- ClinicalTrials.gov ID
- NCT07617272
- Acronym / sponsor ID
- PARIS-BIO / 5.1.1-2025-027483
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- Prostate cancer, Neoadjuvant, Darolutamide, ARPI, Prediction of treatment response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Sahlgrenska University Hospital, Philips Intellectual Property & Standards, OHMX.bio, European Union, Bayer
- Study start
- 9 Nov 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PARIS-BIO study evaluates whether a novel genomic biomarker, the PCAI ImmunoScore, can predict the response to neoadjuvant treatment with Darolutamide in patients with high-risk localized or locally advanced prostate cancer. Patients will receive Darolutamide monotherapy for 90-120 days prior to radical prostatectomy. The study aims to validate if the biomarker can identify patients who achieve Minimal Residual Disease (MRD) at the time of surgery.
Detailed description
High-risk prostate cancer patients are at risk for recurrence after local therapy. The presence of micro-metastatic disease, undetectable by conventional imaging, likely contributes to the poor prognosis. Neoadjuvant hormonal therapy, particularly with the advent of ARPIs like Darolutamide, has shown promise, but patient selection remains crucial for optimizing outcomes. This Phase II, single-arm, open-label trial investigates the predictive value of the PCAI ImmunoScore, a gene expression signature derived from diagnostic biopsies.
100 participants with high-risk prostate cancer scheduled for radical prostatectomy will be enrolled. They will receive Darolutamide (600 mg twice daily) for a period of 90 to 120 days. MRI imaging will be performed between day 90 and 120 prior to surgery. Radical prostatectomy is performed within the same window.
The primary analysis compares the pre-treatment biomarker score with the pathological response (Minimal Residual Disease) observed in the surgical specimen. Secondary analyses include MRI response, PSA kinetics, and patient-reported functional outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Darolutamide | Experimental | Drug: Darolutamide, Procedure: Radical prostatectomyAll participants receive Darolutamide 600 mg orally twice daily for 90-120 days prior to radical prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Biopsy-confirmed high-risk prostate cancer defined as: Global ISUP score > 3 with any MRI PI-RADS score OR Global ISUP score = 3 with MRI PI-RADS score = 5
- Candidate for radical prostatectomy
- Clinical prostate MRI not older than 3 months at screening
- ECOG performance status score of 0 or 1
- Able to receive Darolutamide for 90-120 days
Key exclusion criteria (5 listed)
- Metastatic (M1) or node-positive (N2) disease
- Prior treatment with androgen receptor antagonists
- Prior treatment with gonadotropin-releasing hormone (GnRH)
- History of prior systemic or local therapy for prostate cancer (including radiation and focal therapy)
- Major surgery <4 weeks prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarolutamideAlso: Neoadjuvant ARPI, NubeqaNeoadjuvant Darolutamide alone (without ADT) 2x300 mg orally twice daily is given to all study subjects for 90-120 days prior to prostatectomy. | Drug | Neoadjuvant Darolutamide |
| Radical prostatectomyAlso: RALP, RARP, Robot-assisted prostatectomyRobot-assisted radical prostatectomy, with or without extirpation of pelvic lymph nodes according to clinician's choice in concordance with local guidelines | Procedure or surgery | Neoadjuvant Darolutamide |
Primary outcome
The association between the pre-treatment probability of treatment response given by PCAI ImmunoScore and the occurrence of minimal residual disease (MRD)
Time frame: MRD is ascertained shortly after radical prostatectomy (day 90-120). PCAI ImmunoScore will be ascertained after bulk sequencing of all samples, tentatively 1 year after surgery of the 100th study subject. The association will be calculated thereafter.
The primary outcome is the association between the pre-treatment PCAI ImmunoScore and the occurrence of minimal residual disease (MRD) after 90-120 days of neoadjuvant Darolutamide treatment. MRD is defined as < 0.05 cm3 residual tumour on final pathology after prostatectomy. The study endpoint MRD will be dichotomized into responder (if MRD is met) or non-responder (if MRD is not met) as input for the statistical data analysis. This classification (ground truth) will be tested in AUROC analysis against the calculated PCAI ImmunoScore-based probability p (0<p<1) of Darolutamide response. PCAI ImmunScore is calculated from RNA sequencing of tumor material from diagnostic (pre-treatment) biopsies. The collection of RNA and calculation of PCAI ImmunoScore will take place after the recruitment period. Sequencing will be performed in bulk once all samples have been collected. The objective is to assess the predictive value of the pre-treatment genomic biomarker for pathological response.
8 secondary outcomes
The association between PCAI ImmunoScore and pathologic complete response (pCR)
Time frame: pCR is ascertained shortly after radical prostatectomy (day 90-120). PCAI ImmunoScore will be ascertained after bulk sequencing of all samples, tentatively 1 year after surgery of the 100th study subject. The association will be calculated thereafter.
Pathological T-stage (pT-stage)
Time frame: Pathological T-stage will be ascertained shortly after radical prostatectomy (day 90-120)
Residual tumor size
Time frame: At the time of radical prostatectomy (day 90-120)
PSA Kinetics
Time frame: Baseline, Day 30, Day 60, Day 90, and within 4 weeks after surgery
Hormonal side effects
Time frame: From baseline up to 12 months post-surgery
Patient-reported urinary continence
Time frame: Pre-surgery (day 80-119), 3 months post-surgery, 12 months post-surgery
Patient-reported erectile function
Time frame: Pre-surgery (day 80-119), 3 months post-surgery, 12 months post-surgery
MRI tumor response
Time frame: Pre-surgery (day 90-120)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter N Wiklund, MD, Professor principal investigator
Region Stockholm represented by Karolinska University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darolutamide and Radical prostatectomy in people with Prostate Cancer (Adenocarcinoma), run by Region Stockholm at 2 sites in Sweden.
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 5 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Per H Vincent, MScEng, PhD (+46(0)708239320, per.vincent@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between the pre-treatment probability of treatment response given by PCAI ImmunoScore and the occurrence of minimal residual disease (MRD) (time frame: MRD is ascertained shortly after radical prostatectomy (day 90-120). PCAI ImmunoScore will be ascertained after bulk sequencing of all samples, tentatively 1 year after surgery of the 100th study subject. The association will be calculated thereafter.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2026.