Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study
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Purpose
The purpose of this study is to evaluate the Canadian Real Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer.
| Condition |
|---|
|
Prostate Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study |
- Duration of progression-free survival, defined as the time from patient recruitment to biochemical progression based on doubling of PSA (Prostate Specific Antigen) velocity or PSA > 5.0, objective tumor progression [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Incidence of refractory disease. [ Time Frame: at every visit for 36 months ] [ Designated as safety issue: No ]
- Levels of total serum testosterone. [ Time Frame: at every visit for 36 months ] [ Designated as safety issue: No ]
- Levels of serum PSA (Prostatic Specific Antigen) [ Time Frame: at every visit for 36 months ] [ Designated as safety issue: No ]
- Patient Quality of Life [ Time Frame: at every visit for 36 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 550 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | May 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Prostate Cancer subjects
Prostate Cancer subjects
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients will be enrolled from the offices of university or community urologists/oncologists across Canada treating patients with PCa.
Inclusion Criteria:
i. Adult > 18 years old
ii. Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel
iii. Diagnosed with Prostate Cancer
iv. Prescribed Lupron as part of his treatment by his treating physician
Exclusion Criteria:
i. Currently participating in another prospective study including controlled clinical trials and observational studies.
• Exclusion of patient participating in other observational studies is necessary in order to prevent over-representation of specific patients in different studies, practical considerations regarding authority to utilize the patient's data and statistical issues related to lack of independence of the observations in different studies triggering multiplicity issues
ii. Patient cannot or will not sign informed consent
iii. Survival expectancy less than 2-3 years as per the treating physician's judgment
iv. 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
v. History of alcohol or drug abuse
vi. No longer than 6 months of therapy if currently on luteinizing hormone-releasing hormone (LHRH) treatment
Contacts and Locations| Contact: Nabil Ackad | 514 832-7439 | nabil.ackad@abbvie.com |
| Contact: Suzanne Lemay | 514-832-7494 | suzanne.lemay@abbvie.com |
| Canada | |
| Site Reference ID/Investigator# 56448 | Recruiting |
| Abbottsford, Canada, V2S 3N6 | |
| Principal Investigator: Site Reference ID/Investigator# 56448 | |
| Site Reference ID/Investigator# 56450 | Recruiting |
| Barrie, Canada, L4M 7G1 | |
| Principal Investigator: Site Reference ID/Investigator# 56450 | |
| Site Reference ID/Investigator# 54902 | Active, not recruiting |
| Brampton, Canada, L6T 4S5 | |
| Site Reference ID/Investigator# 54543 | Recruiting |
| Brantford, Canada, N8S 6T6 | |
| Principal Investigator: Site Reference ID/Investigator# 54543 | |
| Site Reference ID/Investigator# 54904 | Recruiting |
| Burlington, Canada, L7N 3V2 | |
| Principal Investigator: Site Reference ID/Investigator# 54904 | |
| Site Reference ID/Investigator# 57123 | Recruiting |
| Burlington, Canada, L7S 1V2 | |
| Principal Investigator: Site Reference ID/Investigator# 57123 | |
| Site Reference ID/Investigator# 57032 | Recruiting |
| Chicoutimi, Canada, G7H 4J1 | |
| Principal Investigator: Site Reference ID/Investigator# 57032 | |
| Site Reference ID/Investigator# 55512 | Active, not recruiting |
| Granby, Canada, J2G 8Z9 | |
| Site Reference ID/Investigator# 56447 | Recruiting |
| Greenfield Park, Canada, J4V 2H3 | |
| Principal Investigator: Site Reference ID/Investigator# 56447 | |
| Site Reference ID/Investigator# 56452 | Recruiting |
| Guelph, Canada, N1H 5J1 | |
| Principal Investigator: Site Reference ID/Investigator# 56452 | |
| Site Reference ID/Investigator# 89053 | Recruiting |
| Halifax, Canada, B3H 1Y4 | |
| Principal Investigator: Site Reference ID/Investigator# 89053 | |
| Site Reference ID/Investigator# 56446 | Recruiting |
| Kelowna, Canada, V1Y 2H4 | |
| Principal Investigator: Site Reference ID/Investigator# 56446 | |
| Site Reference ID/Investigator# 54903 | Recruiting |
| Laval, Canada, H7G 2E6 | |
| Principal Investigator: Site Reference ID/Investigator# 54903 | |
| Site Reference ID/Investigator# 54907 | Recruiting |
| London, Canada, N6A 5W9 | |
| Principal Investigator: Site Reference ID/Investigator# 54907 | |
| Site Reference ID/Investigator# 74493 | Recruiting |
| Montreal, Canada, H3T 1E2 | |
| Principal Investigator: Site Reference ID/Investigator# 74493 | |
| Site Reference ID/Investigator# 75313 | Recruiting |
| Montreal, Canada, H2L 4M1 | |
| Principal Investigator: Site Reference ID/Investigator# 75313 | |
| Site Reference ID/Investigator# 54909 | Recruiting |
| Newmarket, Canada, L3X 1W1 | |
| Principal Investigator: Site Reference ID/Investigator# 54909 | |
| Site Reference ID/Investigator# 54908 | Recruiting |
| North York, Canada, M2J 1V1 | |
| Principal Investigator: Site Reference ID/Investigator# 54908 | |
| Site Reference ID/Investigator# 54542 | Recruiting |
| Oakville, Canada, L6H 3P1 | |
| Principal Investigator: Site Reference ID/Investigator# 54542 | |
| Site Reference ID/Investigator# 61303 | Recruiting |
| Oshawa, Canada, L1G 8A1 | |
| Principal Investigator: Site Reference ID/Investigator# 61303 | |
| Site Reference ID/Investigator# 79774 | Recruiting |
| Oshawa, Canada, L19 2B9 | |
| Principal Investigator: Site Reference ID/Investigator# 79774 | |
| Site Reference ID/Investigator# 56449 | Recruiting |
| Owensound, Canada, N4K 2J1 | |
| Principal Investigator: Site Reference ID/Investigator# 56449 | |
| Site Reference ID/Investigator# 56917 | Recruiting |
| Peterborough, Canada, K9H 1T6 | |
| Principal Investigator: Site Reference ID/Investigator# 56917 | |
| Site Reference ID/Investigator# 61722 | Recruiting |
| Peterborough, Canada, K9J 7B3 | |
| Principal Investigator: Site Reference ID/Investigator# 61722 | |
| Site Reference ID/Investigator# 56445 | Recruiting |
| Pointe-Claire, Canada, H9R 4S3 | |
| Principal Investigator: Site Reference ID/Investigator# 56445 | |
| Site Reference ID/Investigator# 64145 | Recruiting |
| Richmond Hill, Canada, L4C 3X5 | |
| Principal Investigator: Site Reference ID/Investigator# 64145 | |
| Site Reference ID/Investigator# 54905 | Active, not recruiting |
| Scarborough, Canada, M1S 4V5 | |
| Site Reference ID/Investigator# 54906 | Recruiting |
| Scarborough, Canada, M1P 2T7 | |
| Principal Investigator: Site Reference ID/Investigator# 54906 | |
| Site Reference ID/Investigator# 89633 | Recruiting |
| St. John, Canada, E2L 3JB | |
| Principal Investigator: Site Reference ID/Investigator# 89633 | |
| Site Reference ID/Investigator# 56443 | Completed |
| Surrey,, Canada, V3V 1N1 | |
| Site Reference ID/Investigator# 57762 | Recruiting |
| Toronto, Canada, M1P 2T7 | |
| Principal Investigator: Site Reference ID/Investigator# 57762 | |
| Site Reference ID/Investigator# 60843 | Recruiting |
| Toronto, Canada, M4C 5M5 | |
| Principal Investigator: Site Reference ID/Investigator# 60843 | |
| Site Reference ID/Investigator# 56444 | Recruiting |
| Toronto, Canada, M6A 3B5 | |
| Principal Investigator: Site Reference ID/Investigator# 56444 | |
| Site Reference ID/Investigator# 56451 | Active, not recruiting |
| Toronto, Canada, M6S 4W4 | |
| Site Reference ID/Investigator# 56453 | Recruiting |
| Trois-Rivieres, Canada, G9A 3V7 | |
| Principal Investigator: Site Reference ID/Investigator# 56453 | |
| Site Reference ID/Investigator# 55513 | Recruiting |
| Val d'Or, Canada, J9P 1W3 | |
| Principal Investigator: Site Reference ID/Investigator# 55513 | |
| Study Director: | Linda Assouline, PhD | AbbVie Corporation |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01386684 History of Changes |
| Other Study ID Numbers: | P12-811 |
| Study First Received: | June 30, 2011 |
| Last Updated: | May 2, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by AbbVie:
|
Prostate Cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013