- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01960881
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)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
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)
Time Frame: From Month 0 to Month 18
|
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
Time Frame: From Month 0 to Month 18
|
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
Time Frame: From Month 0 to Month 18
|
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)
Time Frame: From Month 0 to follow-up visits 3,6 and 12 months
|
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
Time Frame: From Month 0 to Month 18
|
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)
Time Frame: From Month 0 to Month 18
|
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)
Time Frame: From Month 0 to Month 18
|
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)
Time Frame: From Month 0 to Month 18
|
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
Time Frame: From Month 0 to Month 18
|
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
Time Frame: From Month 0 to Month 18
|
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.
Time Frame: From Month 0 to Month 18
|
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
Time Frame: From Month 0 to Month 18
|
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)
Time Frame: From Month 0 to Month 18
|
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)
Time Frame: From Month 0 to Month 18
|
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)
Time Frame: Up to Month 18
|
Measured with a self-reported questionnaire.
|
Up to Month 18
|
Lupron Cares Patient Support Program
Time Frame: Up to Month 18
|
Enrollment and use will be assessed for the patient support program.
|
Up to Month 18
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P14-096
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States