Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer

The prognosis for participants is summarized for each visit by the number of participants at each visit with a survival prognosis of 10 years, 5 - 10 years, 1 - 5 years, 6 - 12 months, and \< 6 months. Methods for determining survival prognosis were not prespecified, but were based on the judgement of each Investigator.

Time frame: time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first

Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.

The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.

Time frame: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first

Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.

The number of participants with metastases that are absent, local tumor, single metastases, multiple metastases in 1 organ, and multiple metastases in multiple organs at each visit is summarized.

Time frame: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first

Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.

Response to treatment is summarized by the number of participants at each visit with a complete or partial response, stable disease, or progressive disease. Disease status determination was not predefined, but was based on the judgement of each Investigator.

Time frame: month 3, and every 3 months until disease progression or up to 24 months, whichever came first

Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.

Prostate cancer treatment for all participants is summarized by the number of participants at each visit who took any Lucrin/Lucrin Tridepot, LHRH agonist, anti-androgens, or other drug treatments, or who had any type of surgery or radiotherapy (external radiation or brachytherapy).

Time frame: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first

Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.

The number of participants at baseline with a positive or negative bone scan was summarized. Determination of bone scan status was based on the interpretation of the Investigator or radiologist.

Time frame: at time 0 (Baseline)

Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.

The mean age of all participants at baseline is provided.

Time frame: at time 0 (Baseline)

Population: Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients.

The mean weight of all participants at baseline is provided.

Time frame: at time 0 (Baseline)

Population: Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients.

The number of participants at baseline reported to be in metastasis stage M0 or M1 is summarized. M0: no distant metastasis. M1: metastasis to distant organs beyond regional lymph nodes.

Time frame: at time 0 (Baseline)

Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.

N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present.

Time frame: at time 0 (Baseline)

Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.

In this case, a CT or MRI is considered positive when lymph nodes are detectable. A CT or MRI is considered negative when lymph nodes are not detectable.

Time frame: at time 0 (Baseline)

Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.

The median, minimum, and maximum PSA values in ng/mL at baseline are provided. The mean PSA at baseline is reported in the Primary Outcome Measure section above.

Time frame: at time 0 (Baseline)

Population: Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for PSA at baseline was available for 2,532 patients.

The number of participants by race at baseline is presented.

Time frame: at time 0 (Baseline)

Population: Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for race was available for 2,217 patients.

The number of participants with tumor stages T0, T1, T2, T3, and T4 as reported by the physician or pathologist is summarized. T0: no evidence of primary tumor. T1: histologic tumor confined to prostate; clinically unapparent tumor, undetectable by digital rectal examination or by ultrasound. T2: tumor is confined to prostrate and can be detected by digital rectal examination. T3: tumor extends through the prostate capsule but has not spread to other organs. T4: tumor has invaded adjacent structures/organs other than seminal vesicles.

Time frame: at time 0 (Baseline)

Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.

Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized.

Time frame: at time 0 (Baseline)

Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.

The number of participants at baseline who were positive or negative for tumors via a rectal examination, prostate biopsy, echograph of the hyperechogenic zones, or MRI are provided.

Time frame: at time 0 (Baseline)

Population: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.

The number of participants experiencing a serious adverse event during the course of the study is summarized. See the Reported Adverse Event section for details.

Time frame: Baseline to disease progression or 24 months, whichever came first

Population: Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded.