Oncology and Hematology Department - Pulmonology, Allergology and Thoracic Oncology Division

Hopital Paris Saint-Joseph

Psoriasis

Ulcerative Colitis

Ulcer

Colitis

Prostatic Cancer

Pathologic Constriction

dARolutamide

AbbVie

Boston Scientific

Clinact

Distalmotion

Institut Claudius Regaud

condition

allSponsorName

Bayer

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

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.

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

Hopital Paris Saint-Joseph | Oncology and Hematology Department - Pulmonology, Allergology and Thoracic Oncology Division

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

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