Clinical trial · Observational
Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study
Canadian Real-Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer (CRONOS)
NCT01386684CI-TRIAL-00036112completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the Canadian Real Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with Prostate Cancer
- description
- Patients with prostate cancer who were receiving treatment with leuprolide acetate (Lupron).
Primary outcomes (2)
- measure
- 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
- timeFrame
- 36 months
- description
- 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.
- measure
- 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
- timeFrame
- 36 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.