Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer

Inclusion Criteria:

• Histological evidence of adenocarcinoma of the prostate, including metastatic castration sensitive prostate cancer (mCSPC); castration sensitive prostate cancer (CSPC); castration sensitive prostate cancer (CSPC); metastatic castration resistant prostate cancer (mCRPC)
• Undergone orchiectomy or ongoing GnRH agonist or antagonist therapy for at least 1 month prior to the Screening Visit.
• Eastern Cooperative Oncology Group (ECOG) of 0 or 1
• For Phase1 expansion Groups D & E only, received prior abiraterone or enzalutamide and have documented evidence of progression

Exclusion Criteria:

• Known active central nervous system (CNS) metastases, except those who have been treated with surgery and/or radiation therapy, who are off pharmacologic doses of glucocorticoids, and who are neurologically stable.
• Known additional malignancy beyond prostate cancer that required active treatment with the exception of: adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type; adequately treated Stage I cancer from which the patient is currently in remission and has been in remission for ≥2 years; any other cancer from which the patient has been disease-free for ≥5 years
• Clinically significant cardiac disease
• Received chemotheapy within 2 weeks or 5 half-lives of Screening
• Current treatment with enzalutamide, flutamide, nilutamide, bicalutamide, or any other androgen receptor (AR) blocking agents. Patients who have received anti-androgens or AR blocking agents must have discontinued bicalutamide ≥6 weeks and other antiandrogens ≥4 weeks prior to the first dose of PRL-02.
• Prior treatment with estrogens within the previous 3 months
• Need for systemic glucocorticoids greater than replacement doses; the use of topical, intraocular, inhalational, intranasal, or intra-articular glucocorticoids is permitted.
• Required concomitant use of strong inducers of CYP3A4.
• Known hypersensitivity to PRL-02, abiraterone, abiraterone decanoate, prednisone, or dexamethasone or any of their excipients or components.
• Hemoglobin A1c (HbA1c) >10% in patients previously diagnosed with diabetes mellitus. HbA1c >8% in patients whose diabetes mellitus is previously undiagnosed. (Excluded patients may be rescreened after referral and evidence of improved control of their condition).
• Body mass index > 40 kg/m^2