Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Brief Summary: The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.


Options:
A: Inclusion Criteria:

* Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
* Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan
* At least 2 of the following high-risk prognostic factors: Gleason score of greater than or equal to (\>=8); presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2
* Adequate hematologic, hepatic, and renal function
* Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

* Active infection or other medical condition that would make prednisone use contraindicated
* Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 mg prednisone per day
* Pathological finding consistent with small cell carcinoma of the prostate
* Known brain metastasis
* Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer (the following exception are permitted): up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1; participants may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1)
B: Inclusion criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the prostate,
2. Metastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:

   o At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm
3. Patients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),
4. Life expectancy of at least 6 months,
5. Male aged ≥ 18 years old and ≤ 80 years old ,
6. Hematology values:

   * Hemoglobin ≥ 10.0 g/dL,
   * Platelet count ≥ 100,000/mL,
   * Neutrophil ≥ 1500 cells/mm³
7. Biochemistry values:

   * Renal function: Serum creatinine \< 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,
   * Serum potassium ≥ 4 mmol/L,
   * Liver function:

     * Serum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),
     * AST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),
   * ALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P\<1000U/L if bilirubin is normal)
8. Patients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,
9. Patients willing and clinically fit to receive Docetaxel which is defined by the following :

   * Patients respecting all inclusion and exclusion criteria And
   * Patients with no contraindication to docetaxel according to the SmPC of the drug And
   * Patients presenting all medical requirements to receive docetaxel according to the investigator's opinion.
10. Patients might have received previous radiation therapy directed to bone lesions,
11. Patients able to take oral medication,
12. Patients who have received the information sheet and signed the informed consent form,
13. Male patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel
14. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
15. Patients with a public or a private health insurance coverage, according to local laws for participation in clinical trials.

Exclusion Criteria:

1. Patients with previous definitive local treatment directed to the prostate primary cancer (radiotherapy, brachytherapy, radical prostatectomy, ultrasound, cryotherapy, or other). A previous trans-urethral resection of the prostate (TURP) and previous local treatments of metastases are allowed,
2. Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer,
3. Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone twice daily,
4. Active infection or other medical condition for which prednisone/prednisolone (corticosteroid) use would be contra-indicated,
5. Previously treated with ketoconazole for prostate cancer for more than 7 days,
6. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of randomization,
7. Hypertension not controlled by an anti-hypertensive treatment (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg; 3 consecutive measures taken 5 minutes apart),
8. Severe or moderate hepatic impairment (Child - Pugh class C or B)
9. Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert's disease),
10. History of pituitary or adrenal dysfunction,
11. Clinically known significant heart disease in the past 6 months as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \< 50% at baseline,
12. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
13. Patient with unstable pulmonary disease (eg. Pulmonary embolism)
14. Pathological finding consistent with small cell carcinoma of the prostate,
15. History of malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months,
16. Known allergies, hypersensitivity or intolerance to the study drugs or excipients or docetaxel
17. Administration of an investigational therapeutic within 30 days of randomization,
18. Patients already included in another therapeutic trial involving an experimental drug (patient in a non-experimental trial with no modification of the patient's care can be included),
19. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial. Those conditions should be discussed with the patient before registration in the trial,
20. Individual deprived of liberty or placed under the authority of a tutor.
21. Patients with impaired vision should undergo a prompt and complete ophthalmologic examination.

    Patients with Cystoid Macular Oedema cannot be included due to a potential risk of deterioration associated with docetaxel.
22. Concomitant use of strong CYP3A4 inhibitors (clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin.)
C: Inclusion Criteria:

* Diagnosis of prostate adenocarcinoma as confirmed by the investigator
* Metastatic disease documented by greater than or equal to (\>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
* Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel \<=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization
* Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (\<=) 6 months of ADT prior to randomization
* Allowed prior treatments for localized prostate cancer (all treatments must have been completed \>= 1 year prior to randomization) a) \<= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies

Exclusion Criteria:

* Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
* Known brain metastases
* Lymph nodes as only sites of metastases
* Visceral (ie, liver or lung) metastases as only sites of metastases
* Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
* Prior treatment with other next generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
* History of seizures or medications known to lower seizure threshold
D: Inclusion Criteria:

* Histologically or cytologically confirmed prostate cancer
* Metastatic disease
* On androgen-deprivation therapy for \< 120 days
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

  * PS 2 eligible only if decline in PS is due to metastatic prostate cancer
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ upper limit of normal (ULN)
* Alanine aminotransferase (ALT) ≤ 2.5 times ULN
* Creatinine clearance ≥ 30 mL/min
* Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 times ULN (unless on therapeutic anticoagulation)
* Partial thromboplastin time (PTT) ≤ 1.5 times ULN (unless on therapeutic anticoagulation)
* Fertile patients must use effective contraception
* At least 4 weeks since prior major surgery and recovered from all toxicity prior to randomization
* Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following are true:

  * Therapy was discontinued ≥ 12 months ago AND there is no evidence of disease, as defined by 1 of the following:

    * PSA \< 0.1 ng/dL after prostatectomy plus hormonal therapy
    * PSA \< 0.5 ng/dL and has not doubled above nadir after radiotherapy plus hormonal therapy
  * Therapy lasted no more than 24 months

    * Last depot injection must have expired by the 24-month mark
* Prior palliative radiotherapy allowed if commenced within 30 days before starting androgen deprivation
* Anti-androgen therapy allowed as single-agent therapy ≤ 7 days before medial castration to prevent flare
* More than 30 days (or 6 half-lives) (whichever is longer) since prior participation in another clinical trial
* Concurrent participation in nontherapeutic trials allowed
* Concurrent antiandrogen therapy (e.g., bicalutamide or flutamide) allowed, but not as sole hormonal therapy

Exclusion Criteria:

* Prostate-specific antigen (PSA) level has risen and met criteria for progression from its lowest point between the start of androgen-deprivation therapy and randomization
* Prior malignancy in the past 5 years except for basal cell or squamous cell carcinoma of the skin

  * Other malignancies that are considered to have low potential to progress (e.g., grade 2, T1a transitional cell carcinoma) may be allowed if approved by study chair
* Peripheral neuropathy \> grade 1
* History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* Active cardiac disease, including the following:

  * Active angina
  * Symptomatic congestive heart failure
  * Myocardial infarction within the past 6 months
* Prior chemotherapy in adjuvant or neoadjuvant setting
* Prior hormone therapy in the metastatic setting
* Concurrent 5-alpha reductase inhibitors
* Simultaneous enrollment on Cancer and Leukemia Group B (CALGB) 90202

Answer: C