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)

Summary:

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

Trial Description

Primary Outcome:

  • Changes in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36)
  • Change in exercise duration
  • Change in dietary habits
Secondary Outcome:
  • Change in the patient quality of life (QoL) using the Medical Outcomes Study Short Form - 36 (SF-36)
  • Change in weight
  • Change in Body Mass Index (BMI)
  • Changes in the University of California Los Angeles Prostate Cancer Index (UCLA-PI)
  • Changes in the sexual function using the International Index of Erectile Function (IIEF-5)
  • Number of patients with Adverse Events
  • Changes in the patient's medical condition
  • Proportion of patients with castrate levels of testosterone and undetectable levels of Prostatic Specific Antigen (PSA) at 18 months of treatments.
  • Leuprolide Acetate Utilization
  • Changes in the Doctor-Patient communication (for patients enrolled prior to protocol amendment 2)
  • Caregiver Quality of Life (for patients enrolled under protocol amendment 1)
  • Assessment of Financial Burden on Patient's Family (for patients enrolled under protocol amendment 1)
  • Lupron Cares Patient Support Program
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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society