Prostate Cancer CuredPROGENCT01797692
Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study
A study testing geriatric assessment in people with Prostate Cancer Cured and Healthy Population Control, run by Centre Francois Baclesse at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer Cured, Healthy Population Control
- What is being tested?
- geriatric assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 5 sitesFrance
- Study dates
- Jan 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
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- Affiliation to a social security system
- 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
Who cannot join
- Patients under 75 years
- Patients with recurrent or metastatic
- Persons deprived of liberty or under guardianship
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Clinique Claude BERNARD
Albi, 81000
CHRU
Besançon, 25000
Centre François BACLESSE
Caen, Calvados, 14076
CHIC
Castres, 81 000
Hopitaux universitaires de Strasbourg
Strasbourg, Bas-Rhin, 67000
About this study
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.
- Conditions
- Prostate Cancer Cured, Healthy Population Control
- Being tested
- geriatric assessment
- Keywords
- prostate cancer cured, aged patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geriatric assessmentOther
A single geriatric assessment with a geriatrician was proposed to patients and to control population.
| Study group | Role | What they receive |
|---|---|---|
| geriatric assessment | Other | geriatric assessment Receives: Other: geriatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years after treatment for cancer prostate
Secondary outcomes (3)
Evaluate the anxiety of patients and controls
Evaluate the anxiety of patients and controls
Measured: 10 years after treatment for cancer prostate
Assessing depression patients and controls
Assessing depression patients and controls
Measured: 10 years after treatments for cancer prostate
Assess the nutritional status of patients and controls
Assess the nutritional status of patients and controls
Measured: 10 years after treatments for cancer prostate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer CuredStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797692
- Sponsor's protocol ID
- PROGE
- Other IDs
- 2011-A01256-35
- Acronym
- PROGE
- Status last verified
- Jul 2013
- First submitted
- 5 Feb 2013
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study
- ClinicalTrials.gov ID
- NCT01797692
- Acronym / sponsor ID
- PROGE / PROGE
- Conditions
- Prostate Cancer Cured, Healthy Population Control
- Keywords
- prostate cancer cured, aged patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| geriatric assessment | Other | Other: geriatric assessmentgeriatric assessment |
Who may qualify
- Ages
- 75 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- Patients under 75 years
- Patients with recurrent or metastatic
- Persons deprived of liberty or under guardianship
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 assessmentA single geriatric assessment with a geriatrician was proposed to patients and to control population. | Other | geriatric assessment |
Primary outcome
impact of treatments
Time frame: 10 years after treatment for cancer prostate
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.
3 secondary outcomes
Evaluate the anxiety of patients and controls
Time frame: 10 years after treatment for cancer prostate
Assessing depression patients and controls
Time frame: 10 years after treatments for cancer prostate
Assess the nutritional status of patients and controls
Time frame: 10 years after treatments for cancer prostate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 in people with Prostate Cancer Cured and Healthy Population Control, run by Centre Francois Baclesse at 5 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 12 inclusion and 3 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 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
impact of treatments (time frame: 10 years after treatment for cancer prostate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2015.