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 bilateral orchiectomy or ongoing GnRH agonist or antagonist therapy for at least 6 weeks prior to the first dose of study drug which must be continued throughout the study
Eastern Cooperative Oncology Group (ECOG) of 0 or 1
For Phase1 expansion Groups D & E only, received prior darolutamide, apalutamide, 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 chemotherapy within 2 weeks or 5 half-lives of first dose of study drug
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 12 weeks of the first dose of study drug
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