Informations générales (source: ClinicalTrials.gov)
SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer (SUGAR)
Interventional
Phase 2
Institut Claudius Regaud (Voir sur ClinicalTrials)
août 2023
mai 2030
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | YANN NEUZILLET | 05/05/2025 07:12:14 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | Marc-Olivier TIMSIT | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chu Angers - Angers - France | Souhil LEBDAI | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Bordeaux - France | Franck BLADOU | Contact (sur clinicalTrials) | |||
| CHU Grenoble - Grenoble - France | Gaëlle FIARD | Contact (sur clinicalTrials) | |||
| Chu Henri Mondor - Créteil - France | Alexandre DE LA TAILLE | Contact (sur clinicalTrials) | |||
| CHU Lyon - Sud - Pierre-benite - France | Alain RUFFION | Contact (sur clinicalTrials) | |||
| CHU Rennes - Rennes - France | Romain MATHIEU | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Toulouse - France | Matthieu THOULOUZAN | Contact (sur clinicalTrials) | |||
| Chu Tours - Hopital Bretonneau - Tours - France | Franck BRUYERE | Contact (sur clinicalTrials) | |||
| Clinique La Croix Du Sud - Quint-Fonsegrives - France | Guillaume PLOUSSARD | Contact (sur clinicalTrials) | |||
| Hopital Claude Huriez - Lille - France | Jonathan OLIVIER | Contact (sur clinicalTrials) | |||
| Hopital Foch - Suresnes - France | Yann NEUZILLET | Contact (sur clinicalTrials) | |||
| Institut Bergonié - Bordeaux - France | Guilhem ROUBAUD | Contact (sur clinicalTrials) | |||
| Institut Mutualiste Montsouris - Paris - France | Eric BARRET | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - Marseille - France | Jochen WALZ | Contact (sur clinicalTrials) | |||
| Institut Universitaire Du Cancer Toulouse - Oncopole - Toulouse - France | Guillaume PLOUSSARD | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
1. Age ≥18 years
2. Histologically confirmed adenocarcinoma of the prostate
3. 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
- 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
4. No distant metastasis confirmed by imaging (i.e., MRI/CT-Scan and Bone Scintigraphy
or PET-Scan)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1
6. Patient eligible for radical prostatectomy as per the investigator
7. 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).
8. Patient able to receive darolutamide for up to 9 months as per the investigator
9. Patient able to swallow whole study drug tablets
10. Life expectancy more than 5 years
11. 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
12. Signed informed consent
13. 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
14. Patient affiliated to a Social Health Insurance in France.
1. Age ≥18 years
2. Histologically confirmed adenocarcinoma of the prostate
3. 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
- 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
4. No distant metastasis confirmed by imaging (i.e., MRI/CT-Scan and Bone Scintigraphy
or PET-Scan)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1
6. Patient eligible for radical prostatectomy as per the investigator
7. 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).
8. Patient able to receive darolutamide for up to 9 months as per the investigator
9. Patient able to swallow whole study drug tablets
10. Life expectancy more than 5 years
11. 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
12. Signed informed consent
13. 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
14. Patient affiliated to a Social Health Insurance in France.
1. Distant metastasis (clinical stage M1). Nodal disease below the iliac bifurcation
(clinical stage N1) is not an exclusion.
2. Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma
of the prostate
3. Prior treatment for prostate cancer
4. Castrated men (Bilateral orchiectomy or other)
5. History of any pelvic radiation
6. 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
7. 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
8. 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
9. Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding
disorders secondary to hepatic dysfunction
10. Gastrointestinal conditions affecting absorption
11. Known or suspected contraindications or hypersensitivity to darolutamide
12. 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
13. Major surgery within 28 days before first dose of study treatment
14. 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
15. Patient who has forfeited his/her freedom by administrative or legal award or who is
under legal protection (curatorship and guardianship, protection of justice)
16. Concurrent enrolment in another interventional therapeutic clinical study.
17. 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.