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

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto do Cancer do Estado de São Paulo
• Collaborator: Janssen, LP
• Treatments: Androgens; Goserelin; Prednisone

Criteria

Inclusion Criteria:

• Histologic confirmed prostatic adenocarcinoma

• Non-castrate levels of testosterone (> 150 ng/dL)

• High-risk localized prostate cancer, defined by either:

• Tumor stage T3 by digital rectal examination, or

• Primary tumor Gleason score ≥ 8, or

• PSA ≥ 20 ng/mL

• Willing to undergo prostatectomy as primary treatment for localized prostate cancer

• Adequate hematologic, renal and hepatic function:

• WBC > 3000/uL

• Platelets > 150,000/uL

• Creatinine < 2 mg/dL

• Bilirubin < 1.5 x upper limit of normal (ULN)

• AST/ALT < 2 x ULN

• Karnofsky Performance Status (KPS) ≥ 80%

• Able to swallow the study drugs whole as tablets

Exclusion Criteria:

• Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate

• Current or prior hormonal therapy, radiation therapy or chemotherapy for prostate cancer

• Evidence of metastatic disease (M1) on imaging studies

• Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma

• Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure

• History of prior cardiac arrhythmia.

• Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.