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Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT01081873 (opens ClinicalTrials.gov in a new tab)Other idPMOS-BELG-04-001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
2,717 participants (actual)
Sponsor
Abbott · Industry
Design
Not stated
Countries
2 countries

Belgium, Luxembourg

Start
Jun 2004
Primary completion
Dec 2010
Completion
Dec 2010
First posted
5 Mar 2010 (estimated)
Last update posted
31 Oct 2012 (estimated)
Conditions
Prostatic Neoplasm

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2004200620082010
  1. Ph –

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

    NCT01081873

    Jun 2004 to Dec 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • leuprolide (Lucrin/Lucrin-Tri-depot)Drug

Arms1

  • Other

    Advanced prostate cancer participants

    Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment within local reimbursement guidelines.

Primary outcomes5

Outcomes the sponsor listed as primary.

  1. Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit

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

    Registry description

    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.

  2. Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit

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

    Registry description

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

  3. Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit

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

    Registry description

    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.

  4. 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

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

    Registry description

    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.

  5. 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.

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

    Registry description

    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).

Secondary outcomes(12)

  1. Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)

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

    Registry description

    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.

  2. Epidemiological Data: Mean Weight

    Time frame · at time 0 (Baseline)

    Registry description

    The mean weight of all participants at baseline is provided.

  3. Epidemiological Data: Mean Age

    Time frame · at time 0 (Baseline)

    Registry description

    The mean age of all participants at baseline is provided.

  4. Epidemiological Data: Race

    Time frame · at time 0 (Baseline)

    Registry description

    The number of participants by race at baseline is presented.

  5. 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.

    Time frame · at time 0 (Baseline)

    Registry description

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

  6. Epidemiological Data: PSA at Baseline

    Time frame · at time 0 (Baseline)

    Registry description

    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.

  7. Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.

    Time frame · at time 0 (Baseline)

    Registry description

    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.

  8. Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.

    Time frame · at time 0 (Baseline)

    Registry description

    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.

  9. Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test

    Time frame · at time 0 (Baseline)

    Registry description

    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.

  10. Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.

    Time frame · at time 0 (Baseline)

    Registry description

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

  11. Epidemiological Data: Bone Scan at Baseline

    Time frame · at time 0 (Baseline)

    Registry description

    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.

  12. Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline

    Time frame · at time 0 (Baseline)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first

Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit

GroupValue (participants)
Advanced Prostate Cancer Participants at Baseline782
Advanced Prostate Cancer Participants at Month 359
Advanced Prostate Cancer Participants at Month 645
Advanced Prostate Cancer Participants at Month 928
Advanced Prostate Cancer Participants at Month 1274
Advanced Prostate Cancer Participants at Month 1533
Advanced Prostate Cancer Participants at Month 1844
Advanced Prostate Cancer Participants at Month 2129
Advanced Prostate Cancer Participants at Month 24188
Advanced Prostate Cancer Participants - Last Available Record870
Primary outcomeMean· 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

GroupValue (ng/mL)Spread
Advanced Prostate Cancer Participants at Baseline62.16282.64
Advanced Prostate Cancer Participants at Month 312.9588.03
Advanced Prostate Cancer Participants at Month 66.2334.27
Advanced Prostate Cancer Participants at Month 98.0143.28
Advanced Prostate Cancer Participants at Month 128.4152.84
Advanced Prostate Cancer Participants at Month 158.8844.66
Advanced Prostate Cancer Participants at Month 189.5757.42
Advanced Prostate Cancer Participants at Month 2123.02141.92
Advanced Prostate Cancer Participants at Month 2415.29129.06
Advanced Prostate Cancer Participants - Last Available Record30.32183.21
Primary outcomeNumber· 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

GroupValue (participants)
Advanced Prostate Cancer Participants at Month 3525
Advanced Prostate Cancer Participants at Month 6496
Advanced Prostate Cancer Participants at Month 9402
Advanced Prostate Cancer Participants at Month 12668
Advanced Prostate Cancer Participants at Month 15347
Advanced Prostate Cancer Participants at Month 18401
Advanced Prostate Cancer Participants at Month 21276
Advanced Prostate Cancer Participants at Month 241181
Advanced Prostate Cancer Participants - Last Available Record1420
Primary outcomeNumber· time 0 (Baseline), month 3, and every 3 months thereafter 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

GroupValue (participants)
Advanced Prostate Cancer Participants at Baseline395
Advanced Prostate Cancer Participants at Month 3132
Advanced Prostate Cancer Participants at Month 6100
Advanced Prostate Cancer Participants at Month 991
Advanced Prostate Cancer Participants at Month 12113
Advanced Prostate Cancer Participants at Month 1575
Advanced Prostate Cancer Participants at Month 1882
Advanced Prostate Cancer Participants at Month 2166
Advanced Prostate Cancer Participants at Month 24206
Advanced Prostate Cancer Participants - Last Available Record331
Primary outcomeNumber· time 0 (Baseline), month 3, and every 3 months 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.

GroupValue (participants)
Advanced Prostate Cancer Participants at Baseline2028
Advanced Prostate Cancer Participants at Month 31011
Advanced Prostate Cancer Participants at Month 6817
Advanced Prostate Cancer Participants at Month 9640
Advanced Prostate Cancer Participants at Month 12969
Advanced Prostate Cancer Participants at Month 15540
Advanced Prostate Cancer Participants at Month 18629
Advanced Prostate Cancer Participants at Month 21450
Advanced Prostate Cancer Participants at Month 241628
Advanced Prostate Cancer Participants - Use at Any Visit2384
Secondary and other outcome results(3)
Secondary outcomeNumber· Baseline to disease progression or 24 months, whichever came first

Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)

GroupValue (participants)
Advanced Prostate Cancer Participants121
Secondary outcomeMean· at time 0 (Baseline)

Epidemiological Data: Mean Weight

GroupValue (kg)Spread
Advanced Prostate Cancer Participants77.3610.48
Secondary outcomeMean· at time 0 (Baseline)

Epidemiological Data: Mean Age

GroupValue (years)Spread
Advanced Prostate Cancer Participants75.397.92

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Advanced Prostate Cancer ParticipantsParticipants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.–121 / 27148 / 2714

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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