Eligibility Details:
Key Inclusion Criteria:
1. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the
prostate;
2. Is a candidate for, in the opinion of the investigator, at least 1 year of continuous
androgen deprivation therapy for the management of androgen-sensitive advanced
prostate cancer with one of the following clinical disease state presentations:
1. Evidence of biochemical (PSA) or clinical relapse following local primary
intervention with curative intent, such as surgery, radiation therapy,
cryotherapy, or high-frequency ultrasound and not a candidate for salvage
treatment by surgery; or
2. Newly diagnosed androgen-sensitive metastatic disease; or
3. Advanced localized disease unlikely to be cured by local primary intervention
with either surgery or radiation with curative intent
Note: Once 915 participants are enrolled worldwide only participants with metastatic
advanced prostate cancer will be eligible for the study in all regions except China,
where both metastatic and non-metastatic participants will continue to be enrolled.
3. Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nmol/L);
4. Has a serum PSA concentration at the Screening visit of > 2.0 ng/mL (2.0 μg/L), or,
when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 μg/L) or post
radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 μg/L) above
the post interventional nadir;
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at
initial screening and at baseline.
Key Exclusion Criteria:
1. In the investigator's opinion, is likely to require chemotherapy or surgical therapy
for symptomatic disease management within 2 months of initiating androgen deprivation
therapy;
2. Previously received gonadotropin-releasing hormone analog or other form of androgen
deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If
androgen deprivation therapy was received for ≤ 18 months total duration, then that
therapy must have been completed at least 3 months prior to baseline. If the dosing
interval of the depot is longer than 3 months, then the prior androgen deprivation
therapy must have been completed at least as long as the dosing interval of the depot;
3. Previous systemic cytotoxic treatment for prostate cancer (eg, taxane-based regimen);
4. Metastases to brain per prior clinical evaluation;
5. Scheduled for major surgery after baseline;
6. History of surgical castration.