Informations générales (source: ClinicalTrials.gov)
A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide With Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) Following PSA Response in Participants With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Interventional
Phase 3
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
août 2023
août 2026
16 septembre 2025
The purpose of the study is to determine if the intermittent use of androgen-deprivation
therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC)
who reached a prostate-specific antigen (PSA) level < 0.2 nanograms/millilitres (ng/mL)
after 6 months of treatment with apalutamide and ADT combination therapy provides
non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot
flashes measured as 18-month percent change in severity adjusted hot flash score.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alice BERNARD TESSIER | 12/06/2024 15:21:11 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Chu Rennes Hopital Pontchaillou - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
Critères
Homme
Inclusion Criteria:
- Diagnosis of prostate cancer prior to screening with histologically or cytologically
confirmed adenocarcinoma of the prostate
- For participants not undergoing Gender-affirming care: Metastatic prostate cancer
disease documented by conventional imaging (example, computed tomography [CT],
magnetic resonance imaging [MRI], or bone scan) and/or next-generation imaging [NGI]
demonstrating greater than or equal (>=) 2 distinct extraprostatic sites of
metastasis
- For participants undergoing Gender-affirming care: No evidence of metastasis by
either conventional imaging (example, CT, MRI, or bone scan) and/or NGI is also
acceptable
- For participants not undergoing gender-affirming care: testosterone levels > 50
(ng/dL) nanograms per deciliter at screening, except for those who may have received
ADT prior to screening. Participants are allowed to have received up to 3 months of
(ADT) androgen-deprivation therapy prior to enrollment
- For participants undergoing Gender-affirming care: There is no testosterone level
requirement for inclusion
- Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is
related to stable physical limitations (example, wheelchair-bound due to prior
spinal cord injury) and not related to prostate cancer or associated therapy
- A participant must agree not to plan to conceive a child while enrolled in this
study or within 3 months after the last dose of study treatment
- Must be able to take whole apalutamide tablets by swallowing alone or with another
vehicle (example, applesauce)
- Assigned male at birth, inclusive of all gender identities
- Diagnosis of prostate cancer prior to screening with histologically or cytologically
confirmed adenocarcinoma of the prostate
- For participants not undergoing Gender-affirming care: Metastatic prostate cancer
disease documented by conventional imaging (example, computed tomography [CT],
magnetic resonance imaging [MRI], or bone scan) and/or next-generation imaging [NGI]
demonstrating greater than or equal (>=) 2 distinct extraprostatic sites of
metastasis
- For participants undergoing Gender-affirming care: No evidence of metastasis by
either conventional imaging (example, CT, MRI, or bone scan) and/or NGI is also
acceptable
- For participants not undergoing gender-affirming care: testosterone levels > 50
(ng/dL) nanograms per deciliter at screening, except for those who may have received
ADT prior to screening. Participants are allowed to have received up to 3 months of
(ADT) androgen-deprivation therapy prior to enrollment
- For participants undergoing Gender-affirming care: There is no testosterone level
requirement for inclusion
- Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is
related to stable physical limitations (example, wheelchair-bound due to prior
spinal cord injury) and not related to prostate cancer or associated therapy
- A participant must agree not to plan to conceive a child while enrolled in this
study or within 3 months after the last dose of study treatment
- Must be able to take whole apalutamide tablets by swallowing alone or with another
vehicle (example, applesauce)
- Assigned male at birth, inclusive of all gender identities
- History of seizure or known condition that has been determined to significantly
predispose to seizure per investigator
- Pelvic lymph nodes as only site of metastasis
- Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
- Any of the following within 6 months prior to screening: severe or unstable angina,
myocardial infarction, symptomatic congestive heart failure, uncontrolled
hypertension, clinically significant arterial or venous thromboembolic events
- Gastrointestinal disorder affecting absorption
- Participants who have undergone a bilateral orchiectomy with the exception of
participants who completed this as part of their gender-affirming care or a result
of a variation in physical sex development