Prostate CancerPROGERADNCT02876237

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

A study testing geriatric assessment and quality of life and Radiotherapy in people with Prostate Cancer, run by Institut Cancerologie de l'Ouest at 10 sites in France.

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

Who is it for?: Ages 75 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: geriatric assessment and quality of life and Radiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 208 participants
Where: 10 sitesFrance
Study dates: Feb 2015to Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years and older
Men only
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

France10 sites

Institut de Cancérologie de l'Ouest
Angers, 49055
Hopital Henri Mondor
Créteil, 94000
Centre Georges François Leclerc
Dijon, 21079
CHD
La Roche-sur-Yon, 85925
Centre Hospitalier Bretagne Sud
Lorient, 56100
Centre Catherine de Sienne
Nantes, 44202
Clinique Armoricaine de Radiologie
Saint-Brieuc, 22015
CHP
Saint-Grégoire, 35760
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44606
Institut de Cancérologie de Loire
Saint-Priest-en-Jarez, 42270

Other trials in France

About this study

Official title: Patient Over 75 Years With Prostate Cancer: Geriatric Determinants of General Repercussion of Radiotherapy With Curative Intent

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.

Conditions: Prostate Cancer
Being tested: geriatric assessment and quality of life, Radiotherapy
Medical subject headings: Prostatic Neoplasms

What participants receive

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

geriatric assessment and quality of lifeOther
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.
RadiotherapyRadiation
standard radiotherapy

Study groups in NCT02876237
Study group	Role	What they receive
geriatric assessment and quality of life	Experimental	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. Receives: Other: geriatric assessment and quality of life; Radiation: Radiotherapy

What is being measured

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

Change in Global Health Status Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Change in global health status will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), scored from 0 to 100. Changes between baseline and follow-up will be categorized as follows: deterioration defined as a decrease of 10 points or more, improvement defined as an increase of 10 points or more, and stability defined as changes within ±10 points.
Measured: From baseline to 2 months after radiotherapy

Secondary outcomes (1)

Change in Global Health Status Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Change in Global Health Status will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status scale. Scores range from 0 to 100, with higher scores indicating better quality of life. Changes between baseline and follow-up will be categorized as follows: deterioration defined as a decrease of 10 points or more, improvement defined as an increase of 10 points or more, and stability defined as changes within ±10 points.
Measured: From baseline to 6 months after radiotherapy

Timeline

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

Feb 2015Aug 2017

First posted23 Aug 2016 (estimated)
Study startFeb 2015
Primary completionFeb 2017
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 208 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02876237
Sponsor's protocol ID: ICO-A-2014-04
Other IDs: 2014-A00300-47
Acronym: PROGERAD
Status last verified: Jun 2026
First submitted: 22 Jul 2016
Last updated: 30 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Over 75 Years With Prostate Cancer: Geriatric Determinants of General Repercussion of Radiotherapy With Curative Intent
ClinicalTrials.gov ID: NCT02876237
Acronym / sponsor ID: PROGERAD / ICO-A-2014-04
Conditions: Prostate Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 208 participants (actual)
Lead sponsor: Institut Cancerologie de l'OuestUniversity, hospital or other
Study start: Feb 2015
Primary completion: Feb 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 23 Aug 2016 (estimated)
Results: Posted 30 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
geriatric assessment and quality of life	Experimental	Other: geriatric assessment and quality of life, Radiation: RadiotherapyIncluded 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.

Who may qualify

Ages: 75 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
geriatric assessment and quality of lifeIncluded 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.	Other	geriatric assessment and quality of life
Radiotherapystandard radiotherapy	Radiation	geriatric assessment and quality of life

Primary outcome

Change in Global Health Status Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: From baseline to 2 months after radiotherapy
Change in global health status will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), scored from 0 to 100. Changes between baseline and follow-up will be categorized as follows: deterioration defined as a decrease of 10 points or more, improvement defined as an increase of 10 points or more, and stability defined as changes within ±10 points.

1 secondary outcome

Change in Global Health Status Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: From baseline to 6 months after radiotherapy

Results and safety

Results posted to the registry on 30 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Geriatric Assessment and Quality of Life	208	208

Primary outcome: Change in Global Health Status Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Time frame: From baseline to 2 months after radiotherapy. Count of participants. Unit: Participants

Measure	Geriatric Assessment and Quality of Life n = 190
Deterioration ≥ 10 points	55
Stable (±10 points)	95
Improvement ≥ 10 points	40

Population analysed: A total of 208 participants were enrolled in the study. The primary outcome analysis was performed on 190 participants who had evaluable questionnaire data for the primary endpoint. Eighteen participants were excluded from the primary outcome analysis because the required questionnaires were not completed and therefore no assessable primary endpoint data were available.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Geriatric Assessment and Quality of Life	0 of 208 (0%)	0 of 208 (0%)	0 of 208

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aurore GOINEAU, MD principal investigator

Institut de Cancerologie de l'Ouest

Stéphane SUPIOT, MD principal investigator

Institut de Cancérologie de l'Ouest

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing geriatric assessment and quality of life and Radiotherapy in people with Prostate Cancer, run by Institut Cancerologie de l'Ouest at 10 sites in France.

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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. 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?

Yes. Results are posted in the registry (first posted 30 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Global Health Status Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (time frame: From baseline to 2 months after radiotherapy). 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 NCT02876237.

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 30 Oct 2026.