Status and phase
Conditions
Treatments
About
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.
Full description
In the prostate specific antigen (PSA) era, about 15% to 20% of patients are diagnosed with high-risk localized disease and radical prostatectomy is a standard therapy for this subgroup of patients. However, despite best local therapy, about 30-60% of high-risk patients will eventually develop biochemical relapse and a significant proportion of these patients may progress with metastatic disease and die from prostate cancer. Currently, there is no data supporting the use of neoadjuvant therapy for patients with high-risk disease since studies failed to demonstrate clinically significant benefit with standard androgen deprivation therapy (ADT). Following improved outcomes in other malignancies with the use of neoadjuvant therapy with active drugs in the metastatic setting, there is a growing interest in evaluating new-generation androgen receptor (AR)-targeted therapy in earlier stages of prostate cancer. Therefore, the goal of this study is to evaluate the efficacy and safety of neoadjuvant therapy with ADT and abiraterone versus maximal androgen blockade using ADT, abiraterone and apalutamide for patients with high-risk localized prostate cancer.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Histologic confirmed prostatic adenocarcinoma
Non-castrate levels of testosterone (> 150 ng/dL)
High-risk localized prostate cancer, defined by either:
Willing to undergo prostatectomy as primary treatment for localized prostate cancer
Adequate hematologic, renal and hepatic function:
Karnofsky Performance Status (KPS) ≥ 80%
Able to swallow the study drugs whole as tablets
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
64 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal