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CompletedNCT01797692PROGEUpdated Mar 4, 2015

Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study

An interventional study of geriatric assessment in Prostate Cancer Cured and Healthy Population Control, sponsored by Centre Francois Baclesse. Completed at 5 sites in France. Open to male participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-04.

Sponsored by Centre Francois Baclesse · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Not applicable
Ages
75 Years and older
Sex
Male
01

Study summary

This is a multicenter pilot study, proposed for cases and controls 3 departments in France.

Cases are cured patients who have had prostate cancer for at least 10 years. Cookies are healthy subjects selected by lottery on voter list.

Volunteer subjects (cases and controls) are offered a consultation and assessment with an geriatrician.

Read the detailed description

Volunteer subjects (cases and controls) are offered a consultation and assessment with an geriatrician.

During this consultation, ADL, IADL and MMS questionnary will be completed. neurocognitif testing will be done.

02

Conditions studied

  • Prostate Cancer Cured
  • Healthy Population Control

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Keywords

  • prostate cancer cured
  • aged patients
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 74 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Centre Francois Baclesse is the lead sponsor of 109 studies on the registry; 26 are open to participants now.

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

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria for patients:

  • Patients aged 75 years or more
  • Patients with a personal history of prostate cancer with a diagnosis ≥ 10 years
  • Patients who received curative treatment (surgery, radiotherapy,hormone therapy, brachytherapy, technical ablative) for localized prostate cancer
  • Patients considered cured of prostate cancer (regardless of initial treatment)
  • Patients with previously agreed to participate in a case-control study in the general population (study QALIPRO) as a case and volunteer to receive an assessment of geriatric
  • Signature of consent
  • Affiliation to a social security system

Exclusion Criteria for patients:

  • Patients under 75 years
  • Patients with recurrent or metastatic
  • Persons deprived of liberty or under guardianship

Inclusion Criteria for control population:

  • Male subjects
  • Subjects of 75 years or more
  • Subjects that do not have cancer or a history of cancer (except basal cell skin cancer)
  • Subject has previously agreed to participate in a case-control study in the general population (study QALIPRO) as a voluntary witness and to benefit from a balance oncogeriatrics
  • Subjects who gave their written consent to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
74 participants (estimated)

Study arms

  • Other
    geriatric assessment

    geriatric assessment

    Other: geriatric assessment

Interventions

  • Othergeriatric assessment

    A single geriatric assessment with a geriatrician was proposed to patients and to control population.

06

What researchers measure

Primary outcomes

  1. impact of treatments

    The main objective of this study is to evaluate the impact of treatments and their effects on the autonomy of patients over 75 years have been treated and cured for prostate cancer.

    Time frame: 10 years after treatment for cancer prostate

Secondary outcomes

  1. Evaluate the anxiety of patients and controls

    Evaluate the anxiety of patients and controls

    Time frame: 10 years after treatment for cancer prostate

  2. Assessing depression patients and controls

    Assessing depression patients and controls

    Time frame: 10 years after treatments for cancer prostate

  3. Assess the nutritional status of patients and controls

    Assess the nutritional status of patients and controls

    Time frame: 10 years after treatments for cancer prostate

07

Study locations

5 sites
  • Hopitaux universitaires de Strasbourg
    Strasbourg, Bas-Rhin 67000, France
  • Centre François BACLESSE
    Caen, Calvados 14076, France
  • Clinique Claude BERNARD
    Albi, 81000, France
  • CHRU
    Besancon, 25000, France
  • CHIC
    Castres, 81 000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01797692
Lead sponsor
Centre Francois Baclesse
Responsible party
Sponsor
First posted
Feb 22, 2013
Start date
Jan 2013
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Mar 4, 2015

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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