Trial Title:
SUrGery with or Without DARolutamide in High-risk And/or Locally Advanced Prostate Cancer
NCT ID:
NCT05826509
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate cancer
Hight risk
Locally advanced
Radical prostatectomy
ADT sparing
Darolutamide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Surgery alone
Description:
Radical prostatectomy with lymph node dissection will be performed.
Arm group label:
Control arm
Intervention type:
Drug
Intervention name:
Peri-operative darolutamide + surgery.
Description:
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.
Arm group label:
Experimental arm
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.
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.
Criteria for eligibility:
Criteria:
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.
Exclusion Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chu Angers
Address:
City:
Angers
Country:
France
Status:
Recruiting
Contact:
Last name:
Souhil LEBDAI
Phone:
02 41 35 35 16
Email:
solebdai@chu-angers.fr
Facility:
Name:
CHU Bordeaux
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Contact:
Last name:
Franck BLADOU
Phone:
05 57 82 03 40
Email:
franck.bladou@chu-bordeaux.fr
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Contact:
Last name:
Guilhem ROUBAUD
Phone:
05 47 30 32 44
Email:
g.roubaud@bordeaux.unicancer.fr
Facility:
Name:
Chu Henri Mondor
Address:
City:
Créteil
Country:
France
Status:
Recruiting
Contact:
Last name:
Alexandre DE LA TAILLE
Phone:
01 49 81 25 54
Email:
adelataille@hotmail.com
Facility:
Name:
CHU Grenoble
Address:
City:
Grenoble
Country:
France
Status:
Recruiting
Contact:
Last name:
Gaëlle FIARD
Phone:
04 76 76 55 71
Email:
gfiard@chu-grenoble.fr
Facility:
Name:
Hopital Claude Huriez
Address:
City:
Lille
Country:
France
Status:
Recruiting
Contact:
Last name:
Jonathan OLIVIER
Phone:
03 20 44 43 98
Email:
jonathan.olivier@chu-lille.fr
Facility:
Name:
Institut Paoli-Calmettes
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Contact:
Last name:
Jochen WALZ
Phone:
04 91 22 35 32
Email:
walzj@ipc.unicancer.fr
Facility:
Name:
Hopital Europeen Georges-Pompidou
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Marc-Olivier TIMSIT
Phone:
01 56 09 56 51
Email:
marc-olivier.timsit@aphp.fr
Facility:
Name:
Hopital Pitie Salpetriere
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Morgan ROUPRÊT
Phone:
01 41 17 72 97
Email:
mroupret@gmail.com
Facility:
Name:
Institut Mutualiste Montsouris
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Eric BARRET
Phone:
01 56 61 66 19
Email:
eric.barret@imm.fr
Facility:
Name:
CHU Lyon - Sud
Address:
City:
Pierre-benite
Country:
France
Status:
Recruiting
Contact:
Last name:
Alain RUFFION
Phone:
04 72 67 88 08
Email:
alain.ruffion@chu-lyon.fr
Facility:
Name:
Clinique La Croix Du Sud
Address:
City:
Quint-Fonsegrives
Country:
France
Status:
Recruiting
Contact:
Last name:
Guillaume PLOUSSARD
Phone:
05 32 02 72 02
Email:
dr.gploussard@gmail.com
Facility:
Name:
CHU Rennes
Address:
City:
Rennes
Country:
France
Status:
Recruiting
Contact:
Last name:
Romain MATHIEU
Phone:
02 99 28 42 70
Email:
romain.mathieu@chu-rennes.fr
Facility:
Name:
Hopital Foch
Address:
City:
Suresnes
Country:
France
Status:
Recruiting
Contact:
Last name:
Yann NEUZILLET
Phone:
01 46 25 19 61
Email:
y.neuzillet@hopital-foch.com
Facility:
Name:
CHU Toulouse
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Mathieu ROUMIGUIE
Phone:
05 61 32 32 29
Email:
roumiguie.m@chu-toulouse.fr
Facility:
Name:
Institut Universitaire Du Cancer Toulouse - Oncopole
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Guillaume PLOUSSARD
Phone:
05 31 15 60 15
Email:
dr.gploussard@gmail.com
Facility:
Name:
Chu Tours - Hopital Bretonneau
Address:
City:
Tours
Country:
France
Status:
Recruiting
Contact:
Last name:
Franck BRUYERE
Phone:
02 34 38 95 42
Email:
franck.bruyere@gmail.com
Start date:
August 10, 2023
Completion date:
May 2030
Lead sponsor:
Agency:
Institut Claudius Regaud
Agency class:
Other
Collaborator:
Agency:
Bayer
Agency class:
Industry
Source:
Institut Claudius Regaud
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05826509
