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Prostate CancerCRONOS IINCT01960881

Evaluation of Diet and Exercise in Prostate Cancer Patients

An observational study of Prostate Cancer, run by AbbVie at 50 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients Managed with Lupron. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Prostate Cancer
How many people
1,331 participants
Where
50 sitesCanada
Study dates
19 Sep 2013to 10 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be enrolled from the offices of University or community urologists/radio-oncologists across Canada treating patients with PCa

Who may be able to join

  • Adult ≥ 18 years old
  • Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel.
  • Diagnosed with PCa.
  • Prescribed Lupron as part of his treatment by his treating physician.

Who cannot join

  • Patient cannot or will not sign informed consent.
  • 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.
  • More than 6 months of therapy if currently on continuous Luteinizing hormone-releasing hormone (LHRH) treatment.
  • If at study enrollment the intent is to only prescribe 1 dose of Lupron (leuprolide acetate)

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

Canada50 sites

  • Exdeo Clinical Research Inc /ID# 116040

    Abbotsford British Columbia, British Columbia, V2T 1X8

  • The Male/Female Hlth and Res /ID# 116042

    Barrie, Ontario, L4M 7G1

  • The Male/Female Hlth and Res /ID# 124295

    Barrie, Ontario, L4M 7G1

  • Edward F.A. Woods Medicine Professional Corporation /ID# 120695

    Belleville, Ontario, K8P 3Z9

  • Jonathan Giddens Medicine /ID# 116023

    Brampton, Ontario, L6T 4S5

  • Brantford Urology Research /ID# 116026

    Brantford, Ontario, N3S 6T6

  • G. Kenneth Jansz Medicine Professional Corporation /ID# 116024

    Burlington, Ontario, L7N 3V2

  • William R. Love, Medicine, Professional Corporation /ID# 116035

    Burlington, Ontario, L7S 1V2

  • Clinique d'urologie /ID# 116019

    Chicoutimi, Quebec, G7H 4J1

  • CISSS - Hôpital de Gatineau /ID# 131309

    Gatineau, Quebec, J8P 7H2

  • Northern Urology Centre /ID# 141391

    Greater Sudbury, Ontario, P3E 3Z8

  • CISSS de la Monteregie /ID# 116036

    Greenfield Park, Quebec, J4V 2H1

  • CISSS de la Monteregie /ID# 124296

    Greenfield Park, Quebec, J4V 2H1

  • CISSS de la Monteregie /ID# 134137

    Greenfield Park, Quebec, J4V 2H1

  • QE II Health Sciences Centre /ID# 118941

    Halifax, Nova Scotia, B3H 1V7

  • St. Joseph's Healthcare /ID# 163973

    Hamilton, Ontario, L8N 4A6

  • Southern Interior Medical Research /ID# 116025

    Kelowna, British Columbia, V1W 4V5

  • Queen's University /ID# 137983

    Kingston, Ontario, K7L 3J7

  • Clinique d'Urologie á Polyclinique Médicale Concorde /ID# 116037

    Laval, Quebec, H7G 2E6

  • Hopital Cite-de-la-Sante /ID# 130951

    Laval, Quebec, H7M 3L9

  • London Health Sciences Center /ID# 118940

    London, Ontario, N6A 5W9

  • DiCostanzo, Markham, CA /ID# 137272

    Markham, Ontario, L6B 0T1

  • CHUM - Notre-Dame Hospital /ID# 137271

    Montreal, Quebec, H2X 0A9

  • Montreal General Hospital - McGill University Health Center /ID# 141503

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospital /ID# 120416

    Montreal, Quebec, H3T 1E2

  • Mor Urology Inc /ID# 116027

    Newmarket, Ontario, L3X 1W1

  • Stanley Flax Medical Prof Corp /ID# 116022

    North YORK, Ontario, M2J 1V1

  • Fe/Male Health Centers /ID# 116020

    Oakville, Ontario, L6H 3P1

  • The Ottawa Hospital /ID# 132329

    Ottawa, Ontario, K1H 8L6

  • Dr. Sean Pierre Medicine Professional Corporation /ID# 137986

    Ottawa, Ontario, K2H 9N6

  • Kawarth Urology Associates /ID# 116041

    Peterborough, Ontario, K9H 1T6

  • The Medical Centre /ID# 128278

    Peterborough, Ontario, K9J 7B3

  • Ultra-Med Research /ID# 116355

    Pointe-Claire, Quebec, H9R 4S3

  • Abara Medicine Professional Corporation /ID# 137270

    Richmond Hill, Ontario, L4C 3X5

  • Saint John Regional Hospital /ID# 141302

    Saint John, New Brunswick, E2L 4L2

  • Dr. Petar Erdeljan Medicine Professional Corporation /ID# 139641

    Scarborough Village, Ontario, M1P 2T7

  • 1837206 Ontario Inc. /Id# 116038

    Scarborough Village, Ontario, M1S 1T5

  • Urology and Male Fertility /ID# 116043

    Scarborough Village, Ontario, M1S 4V5

  • CHUS - Hopital Fleurimont /ID# 124275

    Sherbrooke, Quebec, J1H 5N4

  • Duplicate_Sunnybrook Health Sciences Ctr /ID# 136597

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre /ID# 137984

    Toronto, Ontario, M5G 2M9

  • Toronto Urology Clin Study Grp /ID# 116044

    Toronto, Ontario, M6A 3B5

  • Toronto West Urology Associates /ID# 116021

    Toronto, Ontario, M6S 4W4

  • Toronto West Urology Associates /ID# 134134

    Toronto, Ontario, M6S 4W4

  • Ctr Sante et Services Sociaux /ID# 131230

    Trois-Rivières, Quebec, G8Z 3R9

  • Groupe De Recherche En Urologie De La Mauricie /ID# 116356

    Trois-Rivières, Quebec, G9A 3V7

  • Clinique des Spécialités Chirurgicales de Val-d'Or /ID# 116039

    Val-d'Or, Quebec, J9P 1W3

  • Dr. J. Paul Whelan, Inc. /ID# 120415

    Victoria, British Columbia, V8V 3N1

  • 9120-1947 Quebec Inc. /ID# 129151

    Westmount, Montreal, Quebec, H3Z 2P9

  • CancerCare Manitoba /ID# 135976

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Prostate Cancer
Keywords
Prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01960881
Study groupRoleWhat they receive
Prostate Cancer PatientsProstate Cancer Patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Month 0 to Month 18

  2. Change in exercise duration

    Assessed at every visit what was the amount of various types of exercise performed in the previous month.

    Measured: From Month 0 to Month 18

  3. 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.

    Measured: From Month 0 to Month 18

Secondary outcomes (13)

  1. 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.

    Measured: From Month 0 to follow-up visits 3,6 and 12 months

  2. Change in weight

    Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

    Measured: From Month 0 to Month 18

  3. 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.

    Measured: From Month 0 to Month 18

  4. 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.

    Measured: From Month 0 to Month 18

  5. 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)

    Measured: From Month 0 to Month 18

  6. 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

    Measured: From Month 0 to Month 18

  7. Changes in the patient's medical condition

    Any change in the patient's medical condition including new onset or worsening of medical conditions.

    Measured: From Month 0 to Month 18

  8. 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.

    Measured: From Month 0 to Month 18

  9. Leuprolide Acetate Utilization

    Utilization of Leuprolide Acetate will be assessed.

    Measured: From Month 0 to Month 18

  10. 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

    Measured: From Month 0 to Month 18

  11. 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.

    Measured: From Month 0 to Month 18

  12. Assessment of Financial Burden on Patient's Family (for patients enrolled under protocol amendment 1)

    Measured with a self-reported questionnaire.

    Measured: Up to Month 18

  13. Lupron Cares Patient Support Program

    Enrollment and use will be assessed for the patient support program.

    Measured: Up to Month 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2013 (estimated)
  2. Study start19 Sep 2013
  3. Primary completion10 Aug 2021
  4. Study completion10 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01960881
Sponsor's protocol ID
P14-096
Acronym
CRONOS II
Status last verified
Aug 2022
First submitted
9 Oct 2013
Last updated
9 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by AbbVie at 50 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01960881.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.

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