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

Study Overview
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Brief Summary
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Document treatment patterns and evaluate LUCRIN / LUCRIN-TRIDEPOT® (Leuprolide) and alternative therapeutic approaches to the treatment of advanced prostate cancer during normal clinical practice and in accordance with the terms of the Belgian marketing authorization and reimbursement conditions.

Official Title
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A Post-Marketing Observational Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatment of Advanced Prostate Cancer

Conditions
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Prostatic Neoplasm

Intervention / Treatment
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* Drug: leuprolide (Lucrin/Lucrin-Tri-depot)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with advanced prostate cancer who have been prescribed Lucrin/ Lucrin-Tri-depot or any other treatment with local reimbursement guidelines; Patients willing to consent to data being collected and provided to Abbott Laboratories. Exclusion Criteria: Contraindications according to the Summary of Product Characteristics (SPC).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced prostate cancer participants<br>Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment within local reimbursement guidelines. | Drug: leuprolide (Lucrin/Lucrin-Tri-depot)<br>* Subcutaneous or intramuscular administration for all participants<br>* Other names: Lucrin-Tri-depot;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness Parameter for Staging of Prostate Cancer: Metastases 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 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first | 
| Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) 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 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first | 
| Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment 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. | month 3, and every 3 months until disease progression or up to 24 months, whichever came first | 
| Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months | 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 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first | 
| Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy. | 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 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs) | 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. | Baseline to disease progression or 24 months, whichever came first | 
| Epidemiological Data: Mean Weight | The mean weight of all participants at baseline is provided. | at time 0 (Baseline) | 
| Epidemiological Data: Mean Age | The mean age of all participants at baseline is provided. | at time 0 (Baseline) | 
| Epidemiological Data: Race | The number of participants by race at baseline is presented. | at time 0 (Baseline) | 
| Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy. | Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized. | at time 0 (Baseline) | 
| Epidemiological Data: PSA at Baseline | 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. | at time 0 (Baseline) | 
| Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test. | 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. | at time 0 (Baseline) | 
| Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4. | 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. | at time 0 (Baseline) | 
| Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test | 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. | at time 0 (Baseline) | 
| Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline. | N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present. | at time 0 (Baseline) | 
| Epidemiological Data: Bone Scan at Baseline | 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. | at time 0 (Baseline) | 
| Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline | 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. | at time 0 (Baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multicenter study