TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer

Inclusion Criteria:

1. Written informed consent obtained prior to any study-related procedure being performed
2. Male patients at least 18 years of age or older at time of consent
3. Pathologically confirmed adenocarcinoma of the prostate
4. Ongoing therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist (unless patient has already had a bilateral orchiectomy) AND serum testosterone level <50 ng/dL at screening
5. Have either metastatic CSPC or metastatic CRPC (per protocol definitions).
6. The following prior treatments and/or surgery for prostate cancer are allowed:
7. CSPC:

• Up to 90 days of androgen deprivation therapy (ADT) withgonadotropin-releasing hormone (GnRH) agonists/antagonists or orchiectomywith or without concurrent anti-androgens prior to patients' randomizationis permitted
• Patients may have one course of palliative radiation or surgical therapy totreat symptoms resulting from metastatic disease (e.g., impending cordcompression or obstructive symptoms) if administered prior to randomization
• Radiation or surgical therapy that was not initiated 4 weeks after the startof ADT or orchiectomy

2. CRPC:

• Previous chemotherapy with docetaxel for metastatic disease with treatmentcompleted at least 1 year prior to screening

7. Discontinuation of flutamide or nilutamide, and other anti-androgens prior to thestart of study medication; discontinuation of bicalutamide prior to start of studymedication
8. Discontinuation of strong cytochrome P450 3A4 (CYP3A4) inducers at least 4 weeks priorto start of study medication
9. Discontinuation of radiotherapy prior to start of study medication
10. Discontinuation of herbal supplements at least 4 weeks prior to the first dose ofstudy medication and for the duration of the trial.
11. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening
12. Normal organ function with acceptable initial laboratory values within the screeningperiod:

• Absolute neutrophil count (ANC): ≥ 1,500/μl
• Albumin: ≥ 3.0g/dL
• Hemoglobin: ≥ 9g/dL
• Platelet count: ≥ 100,000/μl
• Serum Creatinine: ≤ 3.0 x the institutional upper limit of normal (ULN)
• Potassium: ≥ 3.5 mmol/L (within institutional normal range)
• Bilirubin: ≤ 1.5 ULN (unless documented Gilbert's disease)
• Aspartate aminotransferase (AST): ≤ 2.5 x ULN
• Alanine aminotransferase (ALT): ≤ 2.5 x ULN

13. Life expectancy of at least 6 months at screening
14. Patients engaged in sex with women of child-bearing potential agree to use a condomplus another effective contraception method. Patients agree to use a condom whenengaged in any sexual activity, including sex with a pregnant woman. Theserestrictions will apply from the time informed consent is provided until 3 weeks afterthe last dose of study medication is taken.
15. Patient is willing and able to comply with all protocol requirements

Exclusion Criteria:

1. For mCSPC patients: any prior pharmacotherapy, radiation therapy, or surgery formetastatic prostate cancer not specified as allowable treatment in Inclusion Criterion
2. For example, prior therapy with apalutamide or enzalutamide is prohibited as wellas therapy with an investigational agent as described in Exclusion Criterion 16.
3. For mCRPC patients:

• Prior treatment with abiraterone or enzalutamide is prohibited
• Previous chemotherapy is prohibited with exception of docetaxel treatment asspecified in the inclusion criteria 6.

3. Initiation of bisphosphonate or denosumab therapy within 4 weeks prior to the start ofstudy drug/reference product. Patients who are on a stable dose of these medicationsfor at least 4 weeks at the time of starting study drug/reference product will beeligible.
4. Therapy with estrogen within 4 weeks prior to the start of study drug
5. Use of systemic glucocorticoids equivalent to >10 mg prednisone daily. Patients whohave discontinued or reduced dosing to the equivalent of ≤ 10 mg prednisone dailywithin 14 days prior to the start of study drug are eligible
6. Known, symptomatic metastases to the brain or central nervous system involvement (patients with asymptomatic and neurologically stable disease for the past 4 weekswill be permitted)
7. History of adrenal gland dysfunction defined as requiring treatment for adrenalinsufficiency
8. History of other malignancy within the previous 2 years (no longer being activelytreated), with the exceptions of basal cell carcinoma, nonmuscle invasive bladdercancer that has been treated and is under surveillance, or other in-situ cancers witha low likelihood of recurrence
9. Major surgery within 4 weeks prior to the start of study drug
10. Known gastrointestinal disease or condition that could impair absorption inclusive ofgastrocolic fistula, gastroenterostomy, biliary obstruction, cirrhosis, chronicpancreatitis or pancreatic cancer, cystic fibrosis, lactate deficiency, amyloidosis,celiac disease, Crohn's disease, radiation enteritis, intestinal resection, andhistory of bariatric surgery
11. Known history of human immunodeficiency virus or seropositive test for hepatitis Cvirus (HCV) or hepatitis B surface antigen (HBsAg) (note: HCV patients withundetectable viral load will be eligible)
12. Poorly controlled diabetes, defined as hemoglobin A1c (HbA1c) > 8% within the past 12months
13. Uncontrolled hypertension at screening
14. History of New York Heart Association class III or IV heart failure
15. Serious concurrent illness, including psychiatric illness, that could interfere withstudy participation
16. Receipt of another investigational agent within 4 weeks or 5 x the treatmenthalf-life, whichever is longer, of treatment start.
17. Known hypersensitivity or allergy to abiraterone acetate, prednisone or any excipientsin the study drugs
18. In the opinion of the investigator, participation in the trial would prevent thepatient from receiving local standard-of-care treatment for metastatic prostatecancer, if clinically indicated, after completion of the trial
19. Other condition which, in the opinion of the Investigator, would precludeparticipation in this trial.