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COMPLETED
NCT03088124
PHASE2

Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer

Sponsor: Institut Paoli-Calmettes

View on ClinicalTrials.gov

Summary

Many prostate cancer are slow or non progressive forms that would never impair quality or quantity of like of life if undetected. For this localized prostate cancer, the recommendation is an active surveillance, however often experienced by the patient as a lack of care. Thus the introduction of new potent androgen receptor inhibitor raise the question of the benefit of early hormonal therapy in localized prostate cancers. The aim of this study is to assess whether treatment with an oral androgen receptor inhibitor could influence the progression of localized prostate cancer and delay the time to local treatment initiation.

Official title: Active Surveillance With or Without a 6 Months Apalutamide Treatment in Low Risk Prostate Cancer: A Phase II Randomized Multicenter Trial

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

93

Start Date

2017-04-28

Completion Date

2024-10-08

Last Updated

2026-10-14

Healthy Volunteers

No

Interventions

DRUG

Apalutamide

Patients will take orally everyday 240 mg of Apalutamide.

Locations (13)

Institut Paoli Calmettes

Marseille, Bouches du Rhône, France

Hôpital de Cannes

Cannes, France

CHRU Hopital Edouard Herriot

Lyon, France

Clinique Beau Soleil

Montpellier, France

Chu Hotel Dieu

Nantes, France

Chu de Nice

Nice, France

Institut Mutualiste Montsouris

Paris, France

Chu Tenon

Paris, France

Clinique La Croix Du Sud

Quint-Fonsegrives, France

Chu Pontchaillou

Rennes, France

Chu Saint Etienne

Saint-Etienne, France

CHP Saint- Grégoire

Saint-Grégoire, France

Hia Sainte Anne

Toulon, France