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Prostate CancerPhase 2SUGARNCT05826509

SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer

A Phase 2 study testing Surgery alone and Peri-operative darolutamide + surgery. in people with Prostate Cancer, run by Institut Claudius Regaud at 19 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a phase II, multicenter, randomized open-label and comparative trial designed to study the effectiveness and the safety of androgen receptor antagonist (darolutamide) combined with surgery in patients with high-risk and/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
What is being tested?
Surgery alone and Peri-operative darolutamide + surgery.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
19 sitesFrance
Study dates
10 Aug 2023to Feb 2031
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

  • Age ≥18 years
  • Histologically confirmed adenocarcinoma of the prostate
  • High-risk and/or locally advanced prostate cancer diagnosis defined by:
  • One of the following criteria is sufficient to define a high-risk and/or locally advanced prostate cancer:
  • ISUP grade 4 or 5 on biopsies
  • cN1 disease in MRI or PET-Scan
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  • T3b disease in MRI
  • If these criteria are not being identified, two of the following criteria are necessary to define high-risk and/or locally advanced prostate cancer:
  • PSA value >20 ng/ml
  • ≥ 50% of the core of biopsies need to be positive for adenocarcinoma ISUP grade 3
  • T3a disease in MRI
  • No distant metastasis confirmed by imaging (i.e., MRI/CT-Scan and Bone Scintigraphy or PET-Scan)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1
  • Patient eligible for radical prostatectomy as per the investigator
  • Adequate organ function within 28 days prior to start of treatment determined by the following central laboratory values:
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin less than the upper limit of normal (ULN; note that in subjects with Gilbert's syndrome, if total bilirubin is >1.5 X ULN, measure direct and indirect bilirubin. If direct bilirubin is ≤1.5 X ULN, the subject may be eligible);
  • Serum creatinine <1.5 mg/dL;
  • Platelets ≥75,000/uL, without transfusion and/or growth factors within 1 month prior to randomization;
  • Hemoglobin >12.0 g/dL (7.4 mmol), without transfusion and/or growth factors within 1 month prior to randomization;
  • Adequate renal function: creatinine clearance/eGFR within normal limits to baseline assessed as per local standard method;
  • Normal cardiac function according to local standard by 12-lead Electrocardiogram (ECG) (complete, standardized 12-lead recording).
  • Patient able to receive darolutamide for up to 9 months as per the investigator
  • Patient able to swallow whole study drug tablets
  • Life expectancy more than 5 years
  • Men engaged in sexual activity with a woman of childbearing potential should accept (or female partners of men enrolled in the study who are of childbearing potential or are pregnant) to use an highly effective contraception during darolutamide treatment and at least one week after the end of the investigational product
  • Signed informed consent
  • Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations including follow up
  • Patient affiliated to a Social Health Insurance in France.

Who cannot join

  • Distant metastasis (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
  • Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
  • Prior treatment for prostate cancer
  • Castrated men (Bilateral orchiectomy or other)
  • History of any pelvic radiation
  • Any of the following concurrent illness within 6 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
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  • Uncontrolled hypertension as indicated by a systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg at screening despite medical management. Participants with hypertension can enroll provided BP is stable and controlled by anti-hypertensive treatment
  • HIV-positive patient with one or more of the following: Not receiving highly active antiretroviral therapy; Had a change in antiretroviral therapy within 6 months of the start of screening; Receiving antiretroviral therapy that may interfere with study drug; CD4 count <350 at screening; AIDS-defining opportunistic infection within 6 months of start of screening
  • Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction
  • Gastrointestinal conditions affecting absorption
  • Known or suspected contraindications or hypersensitivity to darolutamide
  • Treatment with strong CYP3A4 inducers and P-gp inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug
  • Major surgery within 28 days before first dose of study treatment
  • Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
  • Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
  • Concurrent enrolment in another interventional therapeutic clinical study.
  • Patients with a history of another malignancy at high risk of recurrence within 5 years and with a concurrent malignancy requiring active treatment or having required anticancer treatment within 6 months prior to inclusion.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • Chu Angers

    Angers

  • CHU Bordeaux

    Bordeaux

  • Institut Bergonié

    Bordeaux

  • Chu Henri Mondor

    Créteil

  • CHU Grenoble

    Grenoble

  • Hopital Claude Huriez

    Lille

  • CHU Lyon - Hôpital Edouard Herriot

    Lyon

  • Institut Paoli-Calmettes

    Marseille

  • Hopital Paris Saint-Joseph

    Paris, 75014

  • Hopital Europeen Georges-Pompidou

    Paris

  • Hopital Pitie Salpetriere

    Paris

  • Institut Mutualiste Montsouris

    Paris

  • CHU Lyon - Sud

    Pierre-Bénite

  • Clinique La Croix Du Sud

    Quint-Fonsegrives

  • CHU Rennes

    Rennes

  • Hopital Foch

    Suresnes

  • CHU Toulouse

    Toulouse

  • Institut Universitaire Du Cancer Toulouse - Oncopole

    Toulouse

  • Chu Tours - Hopital Bretonneau

    Tours

Other trials in France

About this study

This is a phase II, multicenter, randomized open-label and comparative trial designed to study the effectiveness and the safety of androgen receptor antagonist (darolutamide) combined with surgery in patients with high-risk and/or locally advanced prostate cancer.

In this trial, patients will be assigned in one of the two following treatments arms:

  • Arm A (control arm): Surgery alone (radical prostatectomy with lymph node dissection)
  • Arm B (experimental arm): Peri-operative darolutamide + surgery (radical prostatectomy with lymph node dissection)

A total of 240 patients will have to be randomized with 120 patients in the control arm and 120 patients in the experimental arm.

Conditions
Prostate Cancer
Being tested
Surgery alone, Peri-operative darolutamide + surgery.
Keywords
Prostate cancer, Hight risk, Locally advanced, Radical prostatectomy, ADT sparing, Darolutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgery aloneOther

    Radical prostatectomy with lymph node dissection will be performed.

  • Peri-operative darolutamide + surgery.Drug

    Darolutamide: 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg; for a total duration of 9 months. Darolutamide will start at day 1.

    Surgery: radical prostatectomy with lymph node dissection will be performed after at least 3 months of darolutamide treatment.

Study groups in NCT05826509
Study groupRoleWhat they receive
Control armActive comparatorNot described
Receives: Other: Surgery alone
Experimental armExperimentalNot described
Receives: Drug: Peri-operative darolutamide + surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The non-curable progression-free survival (NC-PFS) defined as the time from randomization to non-curable event.

    Measured: 5 years for each patient

Secondary outcomes (9)

  1. Metastatic-Free Survival (MFS) defined as the time from randomization to the appearance of distant metastasis or death from any cause.

    Measured: 5 years for each patient

  2. PSA-RFS (Recurrence-Free survival) defined as the time from randomization to PSA recurrence according to the European Association of Urology (EAU) criteria or death from any cause.

    Measured: 5 years for each patient

  3. Overall Survival (OS) defined as the time from randomization to death from any cause.

    Measured: 5 years for each patient

  4. pathological Complete Response (pCR) rate defined as the number of patients presenting a pathological complete response (i.e., absence of residual tumor found in the surgery specimens) divided by the number of patients in the experimental arm.

    Measured: 5 years for each patient

  5. Safety assessed using the NCI-CTCAE Version 5.0.

    Measured: 3 years for each patient

  6. Quality of life will evaluated using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire.

    Subscale Domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Prostate Cancer Subscale.

    Responses to questions use a five-point Likert-type scale ranging from 0 ("not at all") to 4 ("very much so").

    Measured: 1 year for each patient

  7. Quality of life will evaluated using the 5-level EuroQol 5-Dimensional (EQ5D-5L) questionnaire.

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

    Measured: 1 year for each patient

  8. Quality of life will evaluated using the International Prostate Symptom Score (IPSS) questionnaire.

    The I-PSS is based on the answers to seven questions concerning urinary symptoms. Each question is assigned points from 0 (never) to 5 (almost always).

    Measured: 1 year for each patient

  9. Quality of life will evaluated using the International Index of Erectile Function (IIEF-15) questionnaire.

    The IIEF is a 15-item questionnaire containing five domains including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Each item is rated from 0 (or 1) (Severe ED/No sexual activity) to 5 (Mild/No ED).

    Measured: 1 year for each patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study start10 Aug 2023
  3. Primary completionFeb 2031 (estimated)
  4. Study completionFeb 2031 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05826509
Sponsor's protocol ID
22GENH03
Acronym
SUGAR
Status last verified
May 2026
First submitted
12 Apr 2023
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Calleris G, Filleron T, Kesch C, Roubaud G, Pradere B, Cabarrou B, Malavaud B, Roupret M, Mourey L, Ploussard G. Surgery with or Without Darolutamide in High-risk and/or Locally Advanced Prostate Cancer: The SUGAR (CCAFU-PR2) Phase 2 Trial Rationale and Protocol. Eur Urol Oncol. 2024 Jun;7(3):494-500. doi: 10.1016/j.euo.2023.09.020. Epub 2023 Oct 6.

    PubMed 37806843

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surgery alone and Peri-operative darolutamide + surgery. in people with Prostate Cancer, run by Institut Claudius Regaud at 19 sites in France.

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 28 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The non-curable progression-free survival (NC-PFS) defined as the time from randomization to non-curable event. (time frame: 5 years for each patient). 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 NCT05826509, which also lists 1 linked publication.

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 8 May 2026.

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