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| Name | Class |
|---|---|
| JSS Medical Research; CMX Research Inc.; Canadian Urology Research Consortium | UNKNOWN |
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Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed with Lupron.
This is a study utilizing a prospective cohort design. Patients with Prostrate cancer (PCa) who are prescribed Lupron will be entered into the study cohort and will be followed for a maximum of 18 months with recommended assessments at 3, 6, 12 and 18 months after Day 1. Treatment of the patients and follow up will be according to the physicians' judgment, regional regulations and the product monograph.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate Cancer Patients | Prostate Cancer Patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36) | The SF-36 Health is a 36-item general health self-administered questionnaire consisting of 8 scales measuring Physical Function, Physical Role limitations, Vitality, General Health, Pain, Social Function, Emotional Role limitations, and Mental Health. | From Month 0 to Month 18 |
| Change in exercise duration | Assessed at every visit what was the amount of various types of exercise performed in the previous month. | From Month 0 to Month 18 |
| Change in dietary habits | Assessed at every visit to what extent patient's complied with the Canadian Food Guide's recommendation for each of the four food group servings in the previous week. | From Month 0 to Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36) | The SF-36 Health is a 36-item general health self-administered questionnaire consisting of 8 scales measuring Physical Function, Physical Role limitations, Vitality, General Health, Pain, Social Function, Emotional Role limitations, and Mental Health. | From Month 0 to follow-up visits 3,6 and 12 months |
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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 PCa.
iv. Prescribed Lupron as part of his treatment by his treating physician.
Exclusion Criteria:
i. Patient cannot or will not sign informed consent.
ii. 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 PCa.
iii. More than 6 months of therapy if currently on continuous Luteinizing hormone-releasing hormone (LHRH) treatment.
iv. If at study enrollment the intent is to only prescribe 1 dose of Lupron (leuprolide acetate)
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Patients will be enrolled from the offices of University or community urologists/radio-oncologists across Canada treating patients with PCa
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exdeo Clinical Research Inc /ID# 116040 | Abbotsford British Columbia | British Columbia | V2T 1X8 | Canada | ||
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| Change in weight | Change from Baseline is calculated as the post-Baseline value minus the Baseline value. | From Month 0 to Month 18 |
| Change in Body Mass Index (BMI) | BMI is a measure of body fat based on weight in relation to height. Change from Baseline is calculated as the post-Baseline value minus the Baseline value. | From Month 0 to Month 18 |
| Changes in the University of California Los Angeles Prostate Cancer Index (UCLA-PI) | A validated questionnaire designed to measure quality of life in patients with prostate cancer. It consists of 20 questions that assess urinary, sexual, bowel and hormonal function and impairment in patients with prostate cancer. | From Month 0 to Month 18 |
| Changes in the sexual function using the International Index of Erectile Function (IIEF-5) | An abridged 5 item self-administered questionnaire assessing the presence and severity of erectile dysfunction (for patients enrolled prior to protocol amendment 2) | From Month 0 to Month 18 |
| Number of patients with Adverse Events | Adverse events which lead to discontinuation of prescribed treatment under observation, will be coded according to the Medical Dictionary for Regulatory Activities (MeDRA) dictionary of terms | From Month 0 to Month 18 |
| Changes in the patient's medical condition | Any change in the patient's medical condition including new onset or worsening of medical conditions. | From Month 0 to Month 18 |
| Proportion of patients with castrate levels of testosterone and undetectable levels of Prostatic Specific Antigen (PSA) at 18 months of treatments. | The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. A testosterone test checks the level of this male hormone (androgen) in the blood. | From Month 0 to Month 18 |
| Leuprolide Acetate Utilization | Utilization of Leuprolide Acetate will be assessed. | From Month 0 to Month 18 |
| Changes in the Doctor-Patient communication (for patients enrolled prior to protocol amendment 2) | This will be ascertained with the Doctor-Patient Communication/Doctor's Questionnaire and the Doctor-Patient Communication/Patient's Questionnaire that are validated questionnaires developed by the College of Physicians of Quebec | From Month 0 to Month 18 |
| Caregiver Quality of Life (for patients enrolled under protocol amendment 1) | Measured with the Caregiver Quality of Life Index - Cancer scale (CQOLC). This is a 35 item questionnaire that measures the quality of life of individuals caring for cancer patients. | From Month 0 to Month 18 |
| Assessment of Financial Burden on Patient's Family (for patients enrolled under protocol amendment 1) | Measured with a self-reported questionnaire. | Up to Month 18 |
| Lupron Cares Patient Support Program | Enrollment and use will be assessed for the patient support program. | Up to Month 18 |
| Southern Interior Medical Research /ID# 116025 |
| Kelowna |
| British Columbia |
| V1W 4V5 |
| Canada |
| Dr. J. Paul Whelan, Inc. /ID# 120415 | Victoria | British Columbia | V8V 3N1 | Canada |
| CancerCare Manitoba /ID# 135976 | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Saint John Regional Hospital /ID# 141302 | Saint John | New Brunswick | E2L 4L2 | Canada |
| QE II Health Sciences Centre /ID# 118941 | Halifax | Nova Scotia | B3H 1V7 | Canada |
| The Male/Female Hlth and Res /ID# 116042 | Barrie | Ontario | L4M 7G1 | Canada |
| The Male/Female Hlth and Res /ID# 124295 | Barrie | Ontario | L4M 7G1 | Canada |
| Edward F.A. Woods Medicine Professional Corporation /ID# 120695 | Belleville | Ontario | K8P 3Z9 | Canada |
| Jonathan Giddens Medicine /ID# 116023 | Brampton | Ontario | L6T 4S5 | Canada |
| Brantford Urology Research /ID# 116026 | Brantford | Ontario | N3S 6T6 | Canada |
| G. Kenneth Jansz Medicine Professional Corporation /ID# 116024 | Burlington | Ontario | L7N 3V2 | Canada |
| William R. Love, Medicine, Professional Corporation /ID# 116035 | Burlington | Ontario | L7S 1V2 | Canada |
| Northern Urology Centre /ID# 141391 | Greater Sudbury | Ontario | P3E 3Z8 | Canada |
| St. Joseph's Healthcare /ID# 163973 | Hamilton | Ontario | L8N 4A6 | Canada |
| Queen's University /ID# 137983 | Kingston | Ontario | K7L 3J7 | Canada |
| London Health Sciences Center /ID# 118940 | London | Ontario | N6A 5W9 | Canada |
| DiCostanzo, Markham, CA /ID# 137272 | Markham | Ontario | L6B 0T1 | Canada |
| Mor Urology Inc /ID# 116027 | Newmarket | Ontario | L3X 1W1 | Canada |
| Stanley Flax Medical Prof Corp /ID# 116022 | North YORK | Ontario | M2J 1V1 | Canada |
| Fe/Male Health Centers /ID# 116020 | Oakville | Ontario | L6H 3P1 | Canada |
| The Ottawa Hospital /ID# 132329 | Ottawa | Ontario | K1H 8L6 | Canada |
| Dr. Sean Pierre Medicine Professional Corporation /ID# 137986 | Ottawa | Ontario | K2H 9N6 | Canada |
| Kawarth Urology Associates /ID# 116041 | Peterborough | Ontario | K9H 1T6 | Canada |
| The Medical Centre /ID# 128278 | Peterborough | Ontario | K9J 7B3 | Canada |
| Abara Medicine Professional Corporation /ID# 137270 | Richmond Hill | Ontario | L4C 3X5 | Canada |
| Dr. Petar Erdeljan Medicine Professional Corporation /ID# 139641 | Scarborough Village | Ontario | M1P 2T7 | Canada |
| 1837206 Ontario Inc. /Id# 116038 | Scarborough Village | Ontario | M1S 1T5 | Canada |
| Urology and Male Fertility /ID# 116043 | Scarborough Village | Ontario | M1S 4V5 | Canada |
| Duplicate_Sunnybrook Health Sciences Ctr /ID# 136597 | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre /ID# 137984 | Toronto | Ontario | M5G 2M9 | Canada |
| Toronto Urology Clin Study Grp /ID# 116044 | Toronto | Ontario | M6A 3B5 | Canada |
| Toronto West Urology Associates /ID# 116021 | Toronto | Ontario | M6S 4W4 | Canada |
| Toronto West Urology Associates /ID# 134134 | Toronto | Ontario | M6S 4W4 | Canada |
| Clinique d'urologie /ID# 116019 | Chicoutimi | Quebec | G7H 4J1 | Canada |
| CISSS - Hôpital de Gatineau /ID# 131309 | Gatineau | Quebec | J8P 7H2 | Canada |
| CISSS de la Monteregie /ID# 116036 | Greenfield Park | Quebec | J4V 2H1 | Canada |
| CISSS de la Monteregie /ID# 124296 | Greenfield Park | Quebec | J4V 2H1 | Canada |
| CISSS de la Monteregie /ID# 134137 | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Clinique d'Urologie á Polyclinique Médicale Concorde /ID# 116037 | Laval | Quebec | H7G 2E6 | Canada |
| Hopital Cite-de-la-Sante /ID# 130951 | Laval | Quebec | H7M 3L9 | Canada |
| CHUM - Notre-Dame Hospital /ID# 137271 | Montreal | Quebec | H2X 0A9 | Canada |
| Montreal General Hospital - McGill University Health Center /ID# 141503 | Montreal | Quebec | H3G 1A4 | Canada |
| Jewish General Hospital /ID# 120416 | Montreal | Quebec | H3T 1E2 | Canada |
| Ultra-Med Research /ID# 116355 | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| CHUS - Hopital Fleurimont /ID# 124275 | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Ctr Sante et Services Sociaux /ID# 131230 | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
| Groupe De Recherche En Urologie De La Mauricie /ID# 116356 | Trois-Rivières | Quebec | G9A 3V7 | Canada |
| Clinique des Spécialités Chirurgicales de Val-d'Or /ID# 116039 | Val-d'Or | Quebec | J9P 1W3 | Canada |
| 9120-1947 Quebec Inc. /ID# 129151 | Westmount, Montreal | Quebec | H3Z 2P9 | Canada |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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