CClinicalTrials.gg
Status unknownNCT00868868Updated Mar 25, 2009

Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy

An observational study in Prostate Cancer, sponsored by Groupe de recherche en Urologie de la Mauricie. Status unknown at 1 site in Canada. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-03-25.

Sponsored by Groupe de recherche en Urologie de la Mauricie · Observational

The sponsor has not verified this record recently (last verified Mar 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
Male
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Study summary

A randomized clinical trial evaluating the use of a pedometer and brief exercise coaching in prostate cancer patients treated with androgen deprivation therapy. The investigators want to demonstrate if there are less side effects of hormonal therapy and better quality of life in patients who made regular exercise.

Read the detailed description

To evaluate effectiveness of regular exercise and well-being all patients will complete questionnaires about sexual function (IIEF-15) and quality of life. We will also perform at each visits anthropometrics measurement of waist, leg and arm, weight and vital signs. Biochemical analysis and prostatic specific antigen will be done periodically.

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Conditions studied

  • Prostate Cancer

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Keywords

  • Pedometer
  • Prostate
  • Cancer
  • Hormonotherapy
  • Exercise
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

This is the only study on the registry with Groupe de recherche en Urologie de la Mauricie as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Male subjects aged 18 years or older with histological confirmed prostate cancer.

Inclusion criteria

  • 18 years of age or older
  • Histologically proven prostate cancer
  • Treatment plan is to administer long term ADT (androgen deprivation therapy).
  • Patient must currently be treated with ADT for at least 2 weeks before enrollment in trial, and for no more than 6 months. Patient treated with a maximum androgen blockade strategy, combining an anti-androgen agent with a LHRH analog agent are admissible to this protocol, but not patients treated only with an anti-androgen agent alone.
  • Written informed consent to participate in the trial.

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity to Zoladex, Casodex (if applicable), or any component of these product, or to other similar agents
  • Severe cardiac disease (New York Heart Association class III or greater)
  • Severe lung disease
  • Uncontrollable pain
  • Unstable bone lesion
  • Any co-morbidity restraining the patient's ability to walk alone or to modify his walking habits (eg Parkinson's disease, advanced multiple sclerosis, leg amputation, ...)
  • Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.
  • Any contraindication to undertake the 6-minutes walk test (unstable angina or myocardial infarction during the previous month, a resting heart rate of more than 180, systolic blood pressure of more than 180, and a diastolic pressure of more than 100). The patient must have his cardiovascular conditions stabilized and controlled before enrollment in the trial.
  • Unwillingness or incapacity to consent to trial participation.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
06

Study locations

1 of 1 sites recruiting
  • Groupe de Recherche en Urologie de la Mauricie
    Trois-Rivières, G9A 3V7, Canada
    • Dr Alain Maillette, Urologist · Contact · grum@cgocable.ca · 819-373-4141
    • Dr Alain Maillette, Urologist · Principal investigator
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00868868
Lead sponsor
Groupe de recherche en Urologie de la Mauricie
First posted
Mar 25, 2009
Start date
Jun 2008
Primary completion
Sep 2011 (estimated)
Completion
Sep 2011 (estimated)
Last update
Mar 25, 2009

Study contacts

Dr Alain Maillette, urologist
Contact
grum@cgocable.ca
819-373-4141
Dr Alain Maillette, urologist
principal investigator · Groupe de recherche en Urologie de la Mauricie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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