Metastatic Castration-resistant Prostate Cancer (CRPCa)COG-PRONCT02907372
Impact of New Generation Hormono-therapy on Cognitive Functions in Elderly Patients Treated for a Metastatic Prostate Cancer
A study testing neuropsychologic evaluation and oncogeriatric evaluation in people with Metastatic Castration-resistant Prostate Cancer (CRPCa), run by Centre Francois Baclesse at 6 sites in France.
Trial summary
This study will assess the impact of the novel oral hormonal agents (abiraterone acetate or enzalutamide) among elderly metastatic prostate cancer patients. This study will assess the influence of treatments on patients' cognitive functions on a longitudinal basis and evaluate the quality of life and the adherence of… Read more about this study
- Who is it for?
- Ages 70 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer (CRPCa)
- What is being tested?
- neuropsychologic evaluation and oncogeriatric evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 6 sitesFrance
- Study dates
- Nov 2016to Dec 2022
- 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 70 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- For the group of patients of interest :
- Patient must have a metastatic castration-resistant prostate cancer (CRPCa)
- Patient must be 70 years and more
- Performance Status 0-2
- Patient must have not received chemotherapy except one line per Docetaxel for hormono-sensitive situation and which must be completed for a least 18 months before inclusion
- Patient must have been already treated with first generation of androgen deprivation therapy
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- Patient must be asymptomatic or pauci-symptomatic (with pain control, Visual Analog Scale ≤ 3)
- Patient must be candidate for a treatment by a new generation hormono-therapy (with abiraterone acetate or enzalutamide), in accordance to precautions of these treatments described in Summary Characteristics of Product and in combination with androgen deprivation therapy
- Treatment with biphosphonates is authorized
- No known brain metastasis
- Patient must be at least on level 3 on school scale
- Patient has signed informed consent
- For the control group of patients :
- Patient with metastatic prostate cancer without resistance to castration
- Patient must be 70 years and more
- Performance Status 0-2
- Patient must have not received chemotherapy except one line per Docetaxel for hormono-sensitive situation and which must be completed for a least 18 months before inclusion
- Patient must have already started the first generation of androgen deprivation therapy at least since 3 months
- Patient must be asymptomatic or pauci-symptomatic (with pain control, Visual Analog Scale ≤ 3)
- No known brain metastasis
- Patient must be at least on level 3 on school scale
- Patient has signed informed consent
- For the control group of healthy volunteers:
- Man
- No history of cancer,
- 70-year old or more,
- Health status consistent with the participation to the study
- At least on level 3 on school scale
- Signed informed consent
Who cannot join
- For all participants (group of patients of interest, control group of patients and group of healthy volunteers):
- No previous treatment with a new generation hormone therapy (abiraterone acetate or enzalutamide)
- Neurological sequelae of (traumatic brain injury, stroke, multiple sclerosis, epilepsy, neuro-degenerative disease…)
- Known evolutive psychiatric disorder
- Drug use
- Heavy drinking
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- Assessed to be unable or unwilling to comply with the requirements of the protocol
- For group of patients of interest, additional non-inclusion criteria :
- Hypersensitivity to abiraterone acetate or enzalutamide
- For patients candidate for abiraterone acetate, presence of severe hepatic insufficiency
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU
Amiens
centre François Baclesse
Caen
Institut régional du Cancer de Montpellier (ICM)
Montpellier
Chu Rouen
Rouen
Hôpital FOCH
Suresnes
IGR
Villejuif
About this study
This study will assess the impact of the novel oral hormonal agents (abiraterone acetate or enzalutamide) among elderly metastatic prostate cancer patients. This study will assess the influence of treatments on patients' cognitive functions on a longitudinal basis and evaluate the quality of life and the adherence of patients who had or develop cognitive disorders.
Read the detailed description
In this new area of multiples new treatments in advanced PCa that could be proposed to elderly patients, evaluating, understanding and analysing the incidence, severity of cognitive dysfunctions and their impact on quality of life, autonomy and adherence among this group of vulnerable patients with advanced disease is a challenge and is essential to help clinicians taking care of their patients. As the deficits may be subtle and not always related with complaints, cognitive functions need to be assessed by objective sensitive neuropsychological tests and by patient-perceived cognitive self-report questionnaire. In addition to the treatments,there is a range of potential confounders that can contribute to cognitive impairment, such as co-medications, psychological factors (e.g. anxiety or depression), fatigue, or cognitive reserve (i.e. patients with higher education, more occupational attainment, or participation in leisure activities report less clinical or cognitive changes with aging.
The evaluation and the comprehension of the cognitive decline in patients treated for a cancer are complex and need a multidisciplinary approach in human sciences in strong link to clinicians and biologist researchers.
Therefore, this study propose an original unique comprehensive interdisciplinary approach at the interface between public health, clinical research, psychology and biology which would have a direct impact on cancer patient care, including a consortium of neuropsychologists, oncologists and biologist researchers who are working together within the North West canceropole "cognition and cancer" program. In evaluating cognitive functions, mood, quality of life and adherence to treatments, fully in the scope of the proposal, will help to improve our knowledge in this new field of research in human health among cancer patients with a direct impact for the physicians and the patients. The strength of this project is to propose (in complement to the study conducted among patients) a comprehensive approach including an animal model with behavioural tasks as recommended by the ICCTF (International Cognition and Cancer Task Force).
This study will be the first one to address the question of the impact of the novel oral hormonal agents among elderly metastatic prostate cancer patients. This study will assess the influence of treatments on patients' cognitive functions on a longitudinal basis and evaluate the quality of life and the adherence of patients who had or develop cognitive disorders.
- Being tested
- neuropsychologic evaluation, oncogeriatric evaluation
- Keywords
- cognitive dysfunctions, cognitive complaints, metastatic prostate cancer, new generations of hormone-therapy
- Medical subject headings
- Cognitive Dysfunction, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychologic evaluationOther
oncogeriatric evaluationOther
| Study group | Role | What they receive |
|---|---|---|
| cognitive tests | Other | Not described Receives: Other: neuropsychologic evaluation; Other: oncogeriatric evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of elderly patients who will experience a decline in cognitive performances (at least for one cognitive function) by questionnaires
Measured: 3 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
Secondary outcomes (6)
The quantitative score of cognitive functions by questionnaires
Measured: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
the quantitative score of quality of life by questionnaires for evaluate impact of cognitive impairment on quality of life to treatment
Measured: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
the quantitative score of anxiety/depression by questionnaires for evaluate impact of cognitive impairment
Measured: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
the quantitative score of fatigue by questionnaires for evaluate impact of cognitive impairment
Measured: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
the quantitative score of autonomy by geriatric evaluation for evaluate impact of cognitive impairment
Measured: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
the quantitative score of observance of treatment by questionnaire
Measured: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration-resistant Prostate Cancer (CRPCa)Studies 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907372
- Sponsor's protocol ID
- 2016-001248-20
- Other IDs
- 2016
- Acronym
- COG-PRO
- Status last verified
- Jan 2023
- First submitted
- 26 Jul 2016
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lange M, Laviec H, Castel H, Heutte N, Leconte A, Leger I, Giffard B, Capel A, Dubois M, Clarisse B, Coquan E, Di Fiore F, Gouerant S, Bartelemy P, Pierard L, Fizazi K, Joly F. Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol. BMC Cancer. 2017 Aug 16;17(1):549. doi: 10.1186/s12885-017-3534-8.
PubMed 28814281
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of New Generation Hormono-therapy on Cognitive Functions in Elderly Patients Treated for a Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT02907372
- Acronym / sponsor ID
- COG-PRO / 2016-001248-20
- Keywords
- cognitive dysfunctions, cognitive complaints, metastatic prostate cancer, new generations of hormone-therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 20 Sep 2016 (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 study will assess the impact of the novel oral hormonal agents (abiraterone acetate or enzalutamide) among elderly metastatic prostate cancer patients. This study will assess the influence of treatments on patients' cognitive functions on a longitudinal basis and evaluate the quality of life and the adherence of patients who had or develop cognitive disorders.
Detailed description
In this new area of multiples new treatments in advanced PCa that could be proposed to elderly patients, evaluating, understanding and analysing the incidence, severity of cognitive dysfunctions and their impact on quality of life, autonomy and adherence among this group of vulnerable patients with advanced disease is a challenge and is essential to help clinicians taking care of their patients. As the deficits may be subtle and not always related with complaints, cognitive functions need to be assessed by objective sensitive neuropsychological tests and by patient-perceived cognitive self-report questionnaire. In addition to the treatments,there is a range of potential confounders that can contribute to cognitive impairment, such as co-medications, psychological factors (e.g. anxiety or depression), fatigue, or cognitive reserve (i.e. patients with higher education, more occupational attainment, or participation in leisure activities report less clinical or cognitive changes with aging.
The evaluation and the comprehension of the cognitive decline in patients treated for a cancer are complex and need a multidisciplinary approach in human sciences in strong link to clinicians and biologist researchers.
Therefore, this study propose an original unique comprehensive interdisciplinary approach at the interface between public health, clinical research, psychology and biology which would have a direct impact on cancer patient care, including a consortium of neuropsychologists, oncologists and biologist researchers who are working together within the North West canceropole "cognition and cancer" program. In evaluating cognitive functions, mood, quality of life and adherence to treatments, fully in the scope of the proposal, will help to improve our knowledge in this new field of research in human health among cancer patients with a direct impact for the physicians and the patients. The strength of this project is to propose (in complement to the study conducted among patients) a comprehensive approach including an animal model with behavioural tasks as recommended by the ICCTF (International Cognition and Cancer Task Force).
This study will be the first one to address the question of the impact of the novel oral hormonal agents among elderly metastatic prostate cancer patients. This study will assess the influence of treatments on patients' cognitive functions on a longitudinal basis and evaluate the quality of life and the adherence of patients who had or develop cognitive disorders.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive tests | Other | Other: neuropsychologic evaluation, Other: oncogeriatric evaluation |
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (29 listed)
- Patient must have a metastatic castration-resistant prostate cancer (CRPCa)
- Patient must be 70 years and more
- Performance Status 0-2
- Patient must have not received chemotherapy except one line per Docetaxel for hormono-sensitive situation and which must be completed for a least 18 months before inclusion
- Patient must have been already treated with first generation of androgen deprivation therapy
Key exclusion criteria (10 listed)
- For all participants (group of patients of interest, control group of patients and group of healthy volunteers):
- No previous treatment with a new generation hormone therapy (abiraterone acetate or enzalutamide)
- Neurological sequelae of (traumatic brain injury, stroke, multiple sclerosis, epilepsy, neuro-degenerative disease…)
- Known evolutive psychiatric disorder
- Drug use
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 |
|---|---|---|
| neuropsychologic evaluation | Other | cognitive tests |
| oncogeriatric evaluation | Other | cognitive tests |
Primary outcome
The proportion of elderly patients who will experience a decline in cognitive performances (at least for one cognitive function) by questionnaires
Time frame: 3 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
6 secondary outcomes
The quantitative score of cognitive functions by questionnaires
Time frame: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
the quantitative score of quality of life by questionnaires for evaluate impact of cognitive impairment on quality of life to treatment
Time frame: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
the quantitative score of anxiety/depression by questionnaires for evaluate impact of cognitive impairment
Time frame: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
the quantitative score of fatigue by questionnaires for evaluate impact of cognitive impairment
Time frame: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
the quantitative score of autonomy by geriatric evaluation for evaluate impact of cognitive impairment
Time frame: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
the quantitative score of observance of treatment by questionnaire
Time frame: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
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 11 Jan 2023.
- Derived from this study: PubMed 28814281Lange M, Laviec H, Castel H, Heutte N, Leconte A, Leger I, Giffard B, Capel A, Dubois M, Clarisse B, Coquan E, Di Fiore F, Gouerant S, Bartelemy P, Pierard L, Fizazi K, Joly F. Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol. BMC Cancer. 2017 Aug 16;17(1):549. doi: 10.1186/s12885-017-3534-8.
- Individual participant dataSharing planned: No
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuropsychologic evaluation and oncogeriatric evaluation in people with Metastatic Castration-resistant Prostate Cancer (CRPCa), run by Centre Francois Baclesse at 6 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 29 inclusion and 10 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 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The proportion of elderly patients who will experience a decline in cognitive performances (at least for one cognitive function) by questionnaires (time frame: 3 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer). 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 NCT02907372, which also lists 1 linked publication.
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 11 Jan 2023.