Clinical trial NCT01960881: Evaluation of Diet and Exercise in Prostate Cancer Patients
Official title: Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed With Lupron (CRONOS II)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: JSS Medical Research; CMX Research Inc.; Canadian Urology Research Consortium
First posted: 2013-10-11
Enrollment: 1331
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled from the offices of University or community urologists/radio-oncologists across Canada treating patients with PCa

Brief summary: Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed with Lupron.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36)
timeFrame: From Month 0 to Month 18
measure: Change in exercise duration
timeFrame: From Month 0 to Month 18
measure: Change in dietary habits
timeFrame: From Month 0 to Month 18
Secondary outcomes:
measure: Change in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36)
timeFrame: From Month 0 to follow-up visits 3,6 and 12 months
measure: Change in weight
timeFrame: From Month 0 to Month 18
measure: Change in Body Mass Index (BMI)
timeFrame: From Month 0 to Month 18
measure: Changes in the University of California Los Angeles Prostate Cancer Index (UCLA-PI)
timeFrame: From Month 0 to Month 18
measure: Changes in the sexual function using the International Index of Erectile Function (IIEF-5)
timeFrame: From Month 0 to Month 18
measure: Number of patients with Adverse Events
timeFrame: From Month 0 to Month 18
measure: Changes in the patient's medical condition
timeFrame: From Month 0 to Month 18
measure: Proportion of patients with castrate levels of testosterone and undetectable levels of Prostatic Specific Antigen (PSA) at 18 months of treatments.
timeFrame: From Month 0 to Month 18
measure: Leuprolide Acetate Utilization
timeFrame: From Month 0 to Month 18
measure: Changes in the Doctor-Patient communication (for patients enrolled prior to protocol amendment 2)
timeFrame: From Month 0 to Month 18
measure: Caregiver Quality of Life (for patients enrolled under protocol amendment 1)
timeFrame: From Month 0 to Month 18
measure: Assessment of Financial Burden on Patient's Family (for patients enrolled under protocol amendment 1)
timeFrame: Up to Month 18
measure: Lupron Cares Patient Support Program
timeFrame: Up to Month 18
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: Exdeo Clinical Research Inc /ID# 116040
state: British Columbia
city: Kelowna
country: Canada
facility: Southern Interior Medical Research /ID# 116025
state: British Columbia
city: Victoria
country: Canada
facility: Dr. J. Paul Whelan, Inc. /ID# 120415
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba /ID# 135976
state: Manitoba
city: Saint John
country: Canada
facility: Saint John Regional Hospital /ID# 141302
state: New Brunswick
city: Halifax
country: Canada
facility: QE II Health Sciences Centre /ID# 118941
state: Nova Scotia
city: Barrie
country: Canada
facility: The Male/Female Hlth and Res /ID# 116042
state: Ontario
city: Barrie
country: Canada
facility: The Male/Female Hlth and Res /ID# 124295
state: Ontario
city: Belleville
country: Canada
facility: Edward F.A. Woods Medicine Professional Corporation /ID# 120695
state: Ontario
city: Brampton
country: Canada
facility: Jonathan Giddens Medicine /ID# 116023
state: Ontario
city: Brantford
country: Canada
facility: Brantford Urology Research /ID# 116026
state: Ontario
city: Burlington
country: Canada
facility: G. Kenneth Jansz Medicine Professional Corporation /ID# 116024
state: Ontario
city: Burlington
country: Canada
facility: William R. Love, Medicine, Professional Corporation /ID# 116035
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare /ID# 163973
state: Ontario
city: Kingston
country: Canada
facility: Queen's University /ID# 137983
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center /ID# 118940
state: Ontario
city: Markham
country: Canada
facility: DiCostanzo, Markham, CA /ID# 137272
state: Ontario
city: Newmarket
country: Canada
facility: Mor Urology Inc /ID# 116027
state: Ontario
city: North York
country: Canada
facility: Stanley Flax Medical Prof Corp /ID# 116022
state: Ontario
city: Oakville
country: Canada
facility: Fe/Male Health Centers /ID# 116020
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital /ID# 132329
state: Ontario
city: Ottawa
country: Canada
facility: Dr. Sean Pierre Medicine Professional Corporation /ID# 137986
state: Ontario
city: Peterborough
country: Canada
facility: Kawarth Urology Associates /ID# 116041
state: Ontario
city: Peterborough
country: Canada
facility: The Medical Centre /ID# 128278
state: Ontario
city: Richmond Hill
country: Canada
facility: Abara Medicine Professional Corporation /ID# 137270
state: Ontario
city: Scarborough
country: Canada
facility: Dr. Petar Erdeljan Medicine Professional Corporation /ID# 139641
state: Ontario
city: Scarborough
country: Canada
facility: 1837206 Ontario Inc. /Id# 116038
state: Ontario
city: Scarborough
country: Canada
facility: Urology and Male Fertility /ID# 116043
state: Ontario
city: Sudbury
country: Canada
facility: Northern Urology Centre /ID# 141391
state: Ontario
city: Toronto
country: Canada
facility: Duplicate_Sunnybrook Health Sciences Ctr /ID# 136597
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre /ID# 137984
state: Ontario
city: Toronto
country: Canada
facility: Toronto Urology Clin Study Grp /ID# 116044
state: Ontario
city: Toronto
country: Canada
facility: Toronto West Urology Associates /ID# 116021
state: Ontario
city: Toronto
country: Canada
facility: Toronto West Urology Associates /ID# 134134
state: Ontario
city: Chicoutimi
country: Canada
facility: Clinique d'urologie /ID# 116019
state: Quebec
city: Gatineau
country: Canada
facility: CISSS - Hôpital de Gatineau /ID# 131309
state: Quebec
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie /ID# 116036
state: Quebec
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie /ID# 124296
state: Quebec
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie /ID# 134137
state: Quebec
city: Laval
country: Canada
facility: Clinique d'Urologie á Polyclinique Médicale Concorde /ID# 116037
state: Quebec
city: Laval
country: Canada
facility: Hopital Cite-de-la-Sante /ID# 130951
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital - McGill University Health Center /ID# 141503
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital /ID# 120416
state: Quebec
city: Montréal
country: Canada
facility: CHUM - Notre-Dame Hospital /ID# 137271
state: Quebec
city: Pointe-claire
country: Canada
facility: Ultra-Med Research /ID# 116355
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont /ID# 124275
state: Quebec
city: Trois-rivieres
country: Canada
facility: Groupe De Recherche En Urologie De La Mauricie /ID# 116356
state: Quebec
city: Trois-rivières
country: Canada
facility: Ctr Sante et Services Sociaux /ID# 131230
state: Quebec
city: Val D'or
country: Canada
facility: Clinique des Spécialités Chirurgicales de Val-d'Or /ID# 116039
state: Quebec
city: Westmount, Montreal
country: Canada
facility: 9120-1947 Quebec Inc. /ID# 129151
state: Quebec
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: