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.
Study Type
OBSERVATIONAL
Enrollment
2,717
Subcutaneous or intramuscular administration for all participants
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 frame: 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 frame: 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.
Time frame: 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 frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site Reference ID/Investigator# 31147
's-Gravenwezel, Belgium
Site Reference ID/Investigator# 31196
Aartselaar, Belgium
Site Reference ID/Investigator# 31237
Afsnee, Belgium
Site Reference ID/Investigator# 31121
Alken, Belgium
Site Reference ID/Investigator# 31170
Antwerp, Belgium
Site Reference ID/Investigator# 31194
Antwerp, Belgium
Site Reference ID/Investigator# 4872
Antwerp, Belgium
Site Reference ID/Investigator# 31186
Antwerp, Belgium
Site Reference ID/Investigator# 31141
Arlon, Belgium
Site Reference ID/Investigator# 31199
Arlon, Belgium
...and 125 more locations
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
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.
Time frame: Baseline to disease progression or 24 months, whichever came first
Epidemiological Data: Mean Weight
The mean weight of all participants at baseline is provided.
Time frame: at time 0 (Baseline)
Epidemiological Data: Mean Age
The mean age of all participants at baseline is provided.
Time frame: at time 0 (Baseline)
Epidemiological Data: Race
The number of participants by race at baseline is presented.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at time 0 (Baseline)