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Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer

NCT02789878 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-09-15

No results posted yet for this study

Summary

This is a randomized study to evaluate the efficacy and safety neoadjuvant androgen deprivation therapy with goserelin and abiraterone with or without apalutamide prior to radical prostatectomy for patients diagnosed with localized high-risk prostate cancer.

Conditions

Interventions

DRUG

Goserelin

Androgen Deprivation Therapy

DRUG

Prednisone

Corticosteroid

DRUG

Abiraterone

CYP17 inhibitor

DRUG

Apalutamide

Androgen-receptor antagonist

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Diogo A Bastos, MD · Instituto do Cancer do Estado de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2022-04-30
Completion
2022-08-01

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02789878 on ClinicalTrials.gov