A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
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|ClinicalTrials.gov Identifier: NCT04523207|
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : November 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: Apalutamide Drug: ADT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases|
|Actual Study Start Date :||August 19, 2020|
|Estimated Primary Completion Date :||December 11, 2023|
|Estimated Study Completion Date :||December 11, 2023|
Experimental: Apalutamide + Androgen Deprivation Therapy (ADT)
Participants will receive apalutamide 240 milligram (mg) once daily orally along with ADT for 12 cycles (Each cycle is of 28 days).
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) oral tablets.
Other Name: JNJ-56021927
Participants will receive ADT intramuscular or subcutaneously.
- Time to Biochemical Recurrence (BCR) [ Time Frame: Month 24 ]BCR is defined as a confirmed prostate specific antigen (PSA) greater than (>) 0.2 nanogram per milliliter (ng/ml) and time to BCR will be analyzed using Kaplan-Meier method.
- Time to BCR [ Time Frame: Month 12 ]BCR is defined as a confirmed PSA > 0.2 ng/ml and time to BCR will be analyzed using Kaplan-Meier method.
- Time to Serum Testosterone Recovery [ Time Frame: Months 18 and 24 ]The testosterone recovery, defined as a serum testosterone greater than or equal to (>=)150 nanograms per deciliter (ng/dL) which will be analyzed using Kaplan-Meier method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04523207
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|