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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01081873
First received: February 27, 2010
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Prostatic Neoplasm
Drug: leuprolide (Lucrin/Lucrin-Tri-depot)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Post-Marketing Observational Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatment of Advanced Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs) [ Time Frame: Baseline to disease progression or 24 months, whichever came first ] [ Designated as safety issue: Yes ]
    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.

  • Epidemiological Data: Mean Weight [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    The mean weight of all participants at baseline is provided.

  • Epidemiological Data: Mean Age [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    The mean age of all participants at baseline is provided.

  • Epidemiological Data: Race [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    The number of participants by race at baseline is presented.

  • 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) ] [ Designated as safety issue: No ]
    Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized.

  • Epidemiological Data: PSA at Baseline [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4. [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline. [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present.

  • Epidemiological Data: Bone Scan at Baseline [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    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.

  • Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    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.


Enrollment: 2717
Study Start Date: June 2004
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Advanced prostate cancer participants
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)
Subcutaneous or intramuscular administration for all participants
Other Names:
  • Lucrin
  • Lucrin-Tri-depot

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Urologists

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081873

  Show 135 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Simonne Lens Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01081873     History of Changes
Other Study ID Numbers: PMOS-BELG-04-001
Study First Received: February 27, 2010
Results First Received: December 22, 2011
Last Updated: October 26, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by Abbott:
Multicenter study

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 16, 2014