Evaluation of Diet and Exercise in Prostate Cancer Patients (CRONOS II)

Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed With Lupron (CRONOS II)

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 1331

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Abbotsford, British Columbia, Canada, V2T 1X8
      • Exdeo Clinical Research Inc /ID# 116040
    • Kelowna, British Columbia, Canada, V1W 4V5
      • Southern Interior Medical Research /ID# 116025
    • Victoria, British Columbia, Canada, V8V 3N1
      • Dr. J. Paul Whelan, Inc. /ID# 120415
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba /ID# 135976
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital /ID# 141302
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • QE II Health Sciences Centre /ID# 118941
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • The Male/Female Hlth and Res /ID# 116042
    • Barrie, Ontario, Canada, L4M 7G1
      • The Male/Female Hlth and Res /ID# 124295
    • Belleville, Ontario, Canada, K8P 3Z9
      • Edward F.A. Woods Medicine Professional Corporation /ID# 120695
    • Brampton, Ontario, Canada, L6T 4S5
      • Jonathan Giddens Medicine /ID# 116023
    • Brantford, Ontario, Canada, N3S 6T6
      • Brantford Urology Research /ID# 116026
    • Burlington, Ontario, Canada, L7N 3V2
      • G. Kenneth Jansz Medicine Professional Corporation /ID# 116024
    • Burlington, Ontario, Canada, L7S 1V2
      • William R. Love, Medicine, Professional Corporation /ID# 116035
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare /ID# 163973
    • Kingston, Ontario, Canada, K7L 3J7
      • Queen's University /ID# 137983
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Center /ID# 118940
    • Markham, Ontario, Canada, L6B 0T1
      • DiCostanzo, Markham, CA /ID# 137272
    • Newmarket, Ontario, Canada, L3X 1W1
      • Mor Urology Inc /ID# 116027
    • North York, Ontario, Canada, M2J 1V1
      • Stanley Flax Medical Prof Corp /ID# 116022
    • Oakville, Ontario, Canada, L6H 3P1
      • Fe/Male Health Centers /ID# 116020
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital /ID# 132329
    • Ottawa, Ontario, Canada, K2H 9N6
      • Dr. Sean Pierre Medicine Professional Corporation /ID# 137986
    • Peterborough, Ontario, Canada, K9H 1T6
      • Kawarth Urology Associates /ID# 116041
    • Peterborough, Ontario, Canada, K9J 7B3
      • The Medical Centre /ID# 128278
    • Richmond Hill, Ontario, Canada, L4C 3X5
      • Abara Medicine Professional Corporation /ID# 137270
    • Scarborough, Ontario, Canada, M1P 2T7
      • Dr. Petar Erdeljan Medicine Professional Corporation /ID# 139641
    • Scarborough, Ontario, Canada, M1S 1T5
      • 1837206 Ontario Inc. /Id# 116038
    • Scarborough, Ontario, Canada, M1S 4V5
      • Urology and Male Fertility /ID# 116043
    • Sudbury, Ontario, Canada, P3E 3Z8
      • Northern Urology Centre /ID# 141391
    • Toronto, Ontario, Canada, M4N 3M5
      • Duplicate_Sunnybrook Health Sciences Ctr /ID# 136597
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre /ID# 137984
    • Toronto, Ontario, Canada, M6A 3B5
      • Toronto Urology Clin Study Grp /ID# 116044
    • Toronto, Ontario, Canada, M6S 4W4
      • Toronto West Urology Associates /ID# 116021
    • Toronto, Ontario, Canada, M6S 4W4
      • Toronto West Urology Associates /ID# 134134
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 4J1
      • Clinique d'urologie /ID# 116019
    • Gatineau, Quebec, Canada, J8P 7H2
      • CISSS - Hôpital de Gatineau /ID# 131309
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • CISSS de la Monteregie /ID# 116036
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • CISSS de la Monteregie /ID# 124296
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • CISSS de la Monteregie /ID# 134137
    • Laval, Quebec, Canada, H7G 2E6
      • Clinique d'Urologie á Polyclinique Médicale Concorde /ID# 116037
    • Laval, Quebec, Canada, H7M 3L9
      • Hopital Cite-de-la-Sante /ID# 130951
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital - McGill University Health Center /ID# 141503
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital /ID# 120416
    • Montréal, Quebec, Canada, H2X 0A9
      • CHUM - Notre-Dame Hospital /ID# 137271
    • Pointe-claire, Quebec, Canada, H9R 4S3
      • Ultra-Med Research /ID# 116355
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CHUS - Hopital Fleurimont /ID# 124275
    • Trois-rivieres, Quebec, Canada, G9A 3V7
      • Groupe De Recherche En Urologie De La Mauricie /ID# 116356
    • Trois-rivières, Quebec, Canada, G8Z 3R9
      • Ctr Sante et Services Sociaux /ID# 131230
    • Val D'or, Quebec, Canada, J9P 1W3
      • Clinique des Spécialités Chirurgicales de Val-d'Or /ID# 116039
    • Westmount, Montreal, Quebec, Canada, H3Z 2P9
      • 9120-1947 Quebec Inc. /ID# 129151

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Prostate Cancer Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: JSS Medical Research; CMX Research Inc.; Canadian Urology Research Consortium

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 19, 2013
• Primary Completion (ACTUAL): August 10, 2021
• Study Completion (ACTUAL): August 10, 2021

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (ESTIMATE): October 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: P14-096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No