Overview

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.