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Geriatric Determinants of General Repercussion of Radiotherapy for Patient Over 75 Years With Prostate Cancer (PROGERAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02876237
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Brief Summary:
The investigators propose to carry out a prospective analysis of physical impact, psychological, cognitive and social of radiotherapy in all patients over 75 years bearer of localized prostate cancer with an indication of curative radiotherapy. This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities . The quality of life of patients will be evaluated by the QLQ C30 (Quality of Life Questionnaire) European Organisation for Research and Treatment of Cancer (EORTC) before starting treatment, at the end of radiotherapy (2 months) and at 6 months. This short follow-up period seems appropriate in this elderly population and will allow an answer within 2 years to the problem raised in clinical practice.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: geriatric assessment and quality of life Radiation: Radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Patient Over 75 Years With Prostate Cancer: Geriatric Determinants of General Repercussion of Radiotherapy With Curative Intent
Study Start Date : February 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : August 2017

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Arm Intervention/treatment
Experimental: geriatric assessment and quality of life

Included patient must have a geriatric assessment before radiotherapy and 6 months later.

Patient must complete quality of life questionnaire before radiotherapy then 2 and 6 months later.

Other: geriatric assessment and quality of life

Included patient must have a geriatric assessment before radiotherapy and 6 months later. This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities .

Patient must complete quality of life questionnaire before radiotherapy then 2 and 6 months later.


Radiation: Radiotherapy
standard radiotherapy




Primary Outcome Measures :
  1. General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire [ Time Frame: 2 months ]
    Tolerance will be called bad for the loss of 20 or more points (out of 100) between the initial assessment and evaluations at 2 and 6 months. Tolerance will be called correct in other cases. This threshold of 20 points was selected according to the work of Osoba.

  2. Complete geriatric assessment [ Time Frame: 6 months ]
    This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities .

  3. General tolerance of the radiotherapy evaluated by the QLQ-C30 questionnaire [ Time Frame: 6 months ]
    Tolerance will be called bad for the loss of 20 or more points (out of 100) between the initial assessment and evaluations at 2 and 6 months. Tolerance will be called correct in other cases. This threshold of 20 points was selected according to the work of Osoba.



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Man with a histologically proven prostate cancer
  2. Indication of a curative intent radiotherapy
  3. Age ≥ 75 years
  4. Patient who signed an informed consent

Exclusion Criteria:

  1. Patient with metastatic prostate cancer
  2. Patient unable to submit to monitoring of the protocol for social, geographical or family reasons
  3. A person who is not affiliated to a social security scheme or of such a scheme
  4. Patient under trusteeship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876237


Locations
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France
Institut de Cancérologie de l'Ouest
Angers, France, 49055
Hopital Henri Mondor
Creteil, France, 94000
Centre Georges François Leclerc
Dijon, France, 21079
CHD
La Roche Sur Yon, France, 85925
Centre Hospitalier Bretagne Sud
Lorient, France, 56100
Centre Catherine de Sienne
Nantes, France, 44202
Clinique Armoricaine de Radiologie
St Brieuc, France, 22015
CHP
St Gregoire, France, 35760
Clinique Mutualiste de l'Estuaire
St Nazaire, France, 44606
Institut de Cancérologie de Loire
St Priest En Jarez, France, 42270
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
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Principal Investigator: Aurore GOINEAU, MD Institut de Cancerologie de l'Ouest
Principal Investigator: Stéphane SUPIOT, MD Institut de Cancérologie de l'Ouest
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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT02876237    
Other Study ID Numbers: ICO-A-2014-04
2014-A00300-47 ( Other Identifier: French Health Products Safety Agency )
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases