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Study identifier: NCT07333066 Synced from ClinicalTrials.gov · August 03, 2026
● Recruiting

Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.

Condition: Metastatic Hormone-sensitive Prostate Cancer  ·  Sponsor: Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD

PhasePhase 3
Planned participants320
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

About this study

This is a phase III, randomized, open-label, multi-center study to assess the efficacy of treatment intensification with docetaxel plus apalutamide and ADT, assessed by event-free survival, in patients with mHSPC who do not achieve deep PSA response (≤0,2 ng/ml or PSA90 response in combination with a PSA ≤ 4 ng/ml) after initial treatment with apalutamide and ADT. A non-deep PSA response is defined as PSA \> 0.2 ng/ml in combination with a PSA response \< 90%, or a PSA response ≥90% in combination with a PSA \> 4 ng/ml.

This description comes directly from the study's public registry record.

Talk to the study team

GUARD  ·  +34 93 452 79 18  ·  info@guardconsortium.org

Always discuss trial participation with your own doctor first.

Locations (56)

CH BayonneBayonne, FranceNot Yet Recruiting
Institut BergoniéBordeaux, FranceNot Yet Recruiting
CHP Brest - PasteurBrest, FranceNot Yet Recruiting
Hôpital Henri-MondorCréteil, FranceNot Yet Recruiting
GHM Cancérologie - Institut Daniel HollardGrenoble, FranceNot Yet Recruiting
Hôpital Franco-BritanniqueLevallois-Perret, FranceNot Yet Recruiting
GHBS - Hôpital du ScorffLorient, FranceNot Yet Recruiting
Centre De Cancérologie Du Grand MontpellierMontpellier, FranceNot Yet Recruiting
Institut du Cancer de Montpellier - Val d'Aurelle (ICM)Montpellier, FranceNot Yet Recruiting
CHU NîmesNîmes, FranceNot Yet Recruiting
Hospices Civils de Lyon - HCLParis, FranceNot Yet Recruiting
Hôpital Européen Georges PompidouParis, FranceNot Yet Recruiting

+ 44 more locations — full list on the registry record.

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