Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Radical prostatectomy with lymph node dissection will be performed.

Surgery alone

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.

Peri-operative darolutamide + surgery.

Guillaume PLOUSSARD

Loic MOUREY

Souhil LEBDAI

Franck BLADOU

Guilhem ROUBAUD

Alexandre DE LA TAILLE

Gaëlle FIARD

Jonathan OLIVIER

Jochen WALZ

Marc-Olivier TIMSIT

Morgan ROUPRÊT

Eric BARRET

Alain RUFFION

Romain MATHIEU

Yann NEUZILLET

Mathieu ROUMIGUIE

Franck BRUYERE

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

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").

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.

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).

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).

Bayer

Institut Claudius Regaud

Spots Global Cancer Trial Database for hight risk

Every month we try and update this database with for hight risk cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hight risk

Every month we try and update this database with for hight risk cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hight risk cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.