NCT01386684

Brief Summary

The purpose of this study is to evaluate the Canadian Real Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
552

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 2, 2018

Completed
Last Updated

December 13, 2018

Status Verified

August 1, 2017

Enrollment Period

5.2 years

First QC Date

June 30, 2011

Results QC Date

August 24, 2017

Last Update Submit

November 21, 2018

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0

    PFS defined as the time from patient recruitment to biochemical progression based on doubling of prostate specific antigen (PSA) velocity or PSA \> 5.0, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

    36 months

  • Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests

    A second definition of PFS was used due to changes in the definition of biochemical progression: the time from patient recruitment to a change to an absolute value of PSA \> 2 ng/mL on at least 2 consecutive tests, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

    36 months

Secondary Outcomes (34)

  • Castration Resistant Prostate Cancer (CRPC): Number of Participants

    36 months

  • Castration Resistant Prostate Cancer (CRPC): Time to Event

    36 months

  • Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit

    Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

  • Total Serum Testosterone Levels at Each Visit

    Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

  • Total Serum Testosterone: Time to Increase Over Castrate Levels

    36 months

  • +29 more secondary outcomes

Study Arms (1)

Patients with Prostate Cancer

Patients with prostate cancer who were receiving treatment with leuprolide acetate (Lupron).

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be enrolled from the offices of university or community urologists/oncologists across Canada treating patients with PCa.

You may qualify if:

  • Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel
  • Diagnosed with Prostate Cancer
  • Prescribed Lupron as part of his treatment by his treating physician

You may not qualify if:

  • Currently participating in another prospective study including controlled clinical trials and observational studies.
  • Patient cannot or will not sign informed consent
  • Survival expectancy less than 2-3 years as per the treating physician's judgment
  • Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of Prostate Cancer
  • History of alcohol or drug abuse
  • No longer than 6 months of therapy if currently on luteinizing hormone-releasing hormone (LHRH) treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Limitations and Caveats

This was a real-world evidence assessment with clear limitations. One of the key limitations of the study was that treatment patterns were not fully documented. Furthermore, compliance/adherence may have impacted efficacy data.

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
800-633-9110

Study Officials

  • Christina Pelizon, MD

    AbbVie Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2011

First Posted

July 1, 2011

Study Start

June 28, 2011

Primary Completion

September 8, 2016

Study Completion

September 8, 2016

Last Updated

December 13, 2018

Results First Posted

April 2, 2018

Record last verified: 2017-08