A Study to Assess LY01005 Versus Goserelin Comparator (ZOLADEX®) in Patients With Prostate Cancer

This will be a randomized, open-label and active-control study to assess the PK, PD and
safety profiles of LY01005 versus goserelin comparator to be conducted in the USA.

Inclusion Criteria:

1.Patient with an informed consent signed by the patient himself or legally acceptable
representative before any trial-related activities; 2.2. Male patients diagnosed by
confirmation of prostate cancer of any stages for whom endocrine treatment is indicated;
patients with laboratory evidence of "biochemical recurrence" (BCR) are allowed. BCR is
defined as the presence of prostate-specific antigen (PSA) greater than 0.2 ng/mL measured
6 to 13 weeks after radical prostatectomy followed by a confirmatory test showing
persistent PSA greater than 0.2 ng/mL; or "PSA nadir + 2 ng/mL" (treated with radiation
therapy); or PSA doubling time < 6 months without radiographic evidence of recurrence
3.Patients with a Screening testosterone level >1.5 ng/ml; 4.Patients with a life
expectancy of at least 12 months; 5.Patients with an Eastern Cooperative Oncology Group
(ECOG) performance status of ≤2; 6.Patient understands and is willing to comply with the
protocol and related procedures; 7.If having female sexual partners of childbearing
potential, agree to avoid the occurrence of pregnancy during study participation and for
130 days after completing the study by using a highly effective method of contraception
such as barrier method and female contraceptives, including spermicides, etc.

Exclusion Criteria:

1. Patients with a history of orchiectomy, adrenectomy or pituitary resection or
receiving radiotherapy for prostate cancer (patients with prostatectomy are eligible
for the study as are patients who received radiotherapy as long as radiotherapy was
not received within 6 months prior to Screening);

2. Patients who have previously received hormonal therapy for prostate cancer, including
surgical deprivation or sex hormone-regulating agents such as GnRH agonists/inhibitors
as well as estrogen therapy. However, patients previously treated with neo-adjuvant
therapy or adjuvant hormonal therapy for less than 6 months with an interval of at
least 6 months since discontinuation of such therapy at the time of the Screening
Visit can be enrolled;

3. Any patient at risk of urinary tract obstruction or spinal cord compression due to
potential testosterone surge;

4. Patients with confirmed symptoms or signs related with to cerebral metastasis or
radiographically confirmed brain metastases;

5. Patients with a history or presence of any other malignancy except recovered from
basal cell carcinoma with no recurrence within the last 3 years;

6. Patients with a history of severe uncontrolled asthma, anaphylactic reactions, or
severe urticaria and/or angioedema;

7. Patients with uncontrolled diabetes mellitus;

8. Patients with a history of hypersensitivity towards any components of the study drug;

9. Patients who test positive for drugs of abuse or alcohol, have smoked or otherwise
used nicotine-containing products within 6 months prior to the Screening Visit, are
smokers, drug abusers or have taken alcohol within 24 hours prior to dosing;

10. Patients who are taking medications for seizures or oral steroids such as
dexamethasone, methylprednisolone or prednisone;

11. Patients who have taken 5α-reductase inhibitors (finasteride, dutasteride, and
epristeride, etc.) within 3 months prior to Baseline Visit (Day 0);

12. Patients with an intellectual incapacity or language barrier precluding adequate
understanding or co operation;

13. Patients who have received an investigational drug within the last 30 days before the
Screening Visit or longer if considered to possibly influence the outcome of this
trial;

14. Patients who are part of an ongoing trial;

15. Patients with an ECG at Screening of with a QTc >450 ms or have a family history of
prolonged QT syndrome;

16. Patients with abnormal laboratory results which in the judgment of the investigator
would affect the patient's health or the outcome of the trial;

17. Patients with a clinically significant medical condition (other than prostate cancer)
including but not limited to: renal, hematological, gastrointestinal, endocrine,
cardiac, neurological or psychiatric disease, alcohol or drug abuse or any other
condition that may affect the patient's health or the outcome of the trial as judged
by the investigator.