Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study

AbbVie (prior sponsor, Abbott)552 enrolled

Overview

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

This is a Canadian Post Marketing Observational Study utilizing a prospective cohort design. Patients with Prostate Cancer who are prescribed Lupron will be entered into the study cohort and will be followed for a maximum of 36 months with recommended assessments at 3, 6, 12, 18, 24, 30 and 36 months after baseline. Treatment of the patients and follow up will be according to the physician's judgment, regional regulations and the product monograph.

Study Type

OBSERVATIONAL

Enrollment

552

Conditions

Prostate Cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 36 months

Secondary Outcomes

Castration Resistant Prostate Cancer (CRPC): Number of Participants

CRPC defined as PSA \> 2 ng/mL on at least 2 consecutive tests.

Time frame: 36 months

Castration Resistant Prostate Cancer (CRPC): Time to Event

CRPC defined as PSA \> 2 ng/mL on at least 2 consecutive tests. The distribution of time to CRPC was estimated using Kaplan-Meier methodology. The point estimate and standard error of the distribution are provided.

Time frame: 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

Total serum testosterone was assessed at each study visit. The percentage of participants with total serum testosterone ≤ 0.7 nmol/L, \> 0.7 to ≤ 1.7 nmol/L, and \> 1.7 nmol/L are provided at each time point.

Data from ClinicalTrials.gov

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

Total Serum Testosterone Levels at Each Visit

Total serum testosterone was assessed at each study visit.

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

Total Serum Testosterone: Time to Increase Over Castrate Levels

Total serum testosterone was assessed at each study visit. The time to increased total serum testosterone over the castrate levels (\>1.7 nmol/L) are provided. The distribution of time to increase in total serum testosterone levels was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

Time frame: 36 months

Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit

Serum PSA was assessed at each study visit. The percentage of participants with serum PSA \< 1 ng/mL, 1 to \< 5 ng/mL, 5 to \< 10 ng/mL, and ≥10 ng/mL are provided at each time point.

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

Prostatic Specific Antigen (PSA) Levels at Each Visit

Serum PSA was assessed at each study visit.

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

Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit

The FACT-G questionnaire is used with patients of any tumor type to assess patient quality of life (QoL). FACT-G is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-G was analyzed using repeated measures mixed effects general linear model (GLM). A positive change from baseline indicates improved QoL.