Prostate CancerPROS-PROSQoLINCT02853409
Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer
An observational study of Prostate Cancer, run by Ipsen at 14 sites in Spain.
Trial summary
The purpose of this study is to evaluate possible changes in quality of life related to health (HRQL) in locally advanced and metastatic prostate cancer patients, after one year of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 628 participants
- Where
- 14 sitesSpain
- Study dates
- Jan 2014to Dec 2015
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Men ≥ 18 years old
- Symptomatic prostate cancer patients who present symptoms due to prostate cancer disease
- Capacity to comply with the protocol
- Patient with an expected survival > 12 months
Who cannot join
- Patients who are also participating in any other clinical study
- Patient with other malignant diseases, apart from prostate cancer
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital Quirón Campo de Gibraltar
Cadiz
H. San Juan de Dios
Córdoba
Hospital Quiron Vizcaya
Erandio
H. Can Misses
Ibiza Town
Hospital San Juan de Dios
León
H. de Torrelodones
Madrid
H. Montepríncipe
Madrid
Hospital Quirón San Camilo
Madrid
Hospital San Rafael
Madrid
Hospital Parque San Antonio
Málaga
Hospital Quirón Marbella
Marbella
H. Infanta Sofía
San Sebastián de los Reyes
Hospital NISA
Seville
Hospital Sagrado Corazón
Seville
About this study
Official title: Prospective Epidemiological Study to Determine the Variation in the Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer (PROS-PROSQoLI Study)
The purpose of this study is to evaluate possible changes in quality of life related to health (HRQL) in locally advanced and metastatic prostate cancer patients, after one year of follow-up.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)
Measured: 12 months
Secondary outcomes (9)
Socio-demographic characteristics (percentage of patients (a) living married or living with a partner, (b) had completed primary studies, (c) retired or pensioners, (d) patients had a family history of PrCa)
Measured: 12 months
Anthropometric Characteristics - Body Mass Index
Measured: Baseline
Prostate-specific Antigen (PSA)
Measured: Baseline, 12 months
Testosterone level
Measured: Baseline, 12 months
Digital rectal examination
Measured: Baseline, 12 months
Percentage of patients who have undergone previous treatment (surgery, radiotherapy and hormonotherapy)
Measured: 12 months
Anxiety questionnaire (Hospital Anxiety and Depression scales-HAD)
Measured: 12 months
Change in general health status perception (from either patient or physician perspective)
Assessment of health in relation to Prostate Cancer, the options are: very good, quite good, slightly good, neither good nor bad, slightly bad, quite bad or very bad.
Measured: 12 months
Quality of life using EQ-5D questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853409
- Sponsor's protocol ID
- A-92-52014-215
- Acronym
- PROS-PROSQoLI
- Status last verified
- Dec 2018
- First submitted
- 1 Apr 2016
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Epidemiological Study to Determine the Variation in the Quality of Life of Patients With Locally Advanced and Metastatic Prostate Cancer (PROS-PROSQoLI Study)
- ClinicalTrials.gov ID
- NCT02853409
- Acronym / sponsor ID
- PROS-PROSQoLI / A-92-52014-215
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Aug 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.
The purpose of this study is to evaluate possible changes in quality of life related to health (HRQL) in locally advanced and metastatic prostate cancer patients, after one year of follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (4 listed)
- Men ≥ 18 years old
- Symptomatic prostate cancer patients who present symptoms due to prostate cancer disease
- Capacity to comply with the protocol
- Patient with an expected survival > 12 months
Key exclusion criteria (2 listed)
- Patients who are also participating in any other clinical study
- Patient with other malignant diseases, apart from prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)
Time frame: 12 months
9 secondary outcomes
Socio-demographic characteristics (percentage of patients (a) living married or living with a partner, (b) had completed primary studies, (c) retired or pensioners, (d) patients had a family history of PrCa)
Time frame: 12 months
Anthropometric Characteristics - Body Mass Index
Time frame: Baseline
Prostate-specific Antigen (PSA)
Time frame: Baseline, 12 months
Testosterone level
Time frame: Baseline, 12 months
Digital rectal examination
Time frame: Baseline, 12 months
Percentage of patients who have undergone previous treatment (surgery, radiotherapy and hormonotherapy)
Time frame: 12 months
Anxiety questionnaire (Hospital Anxiety and Depression scales-HAD)
Time frame: 12 months
Change in general health status perception (from either patient or physician perspective)
Time frame: 12 months
Quality of life using EQ-5D questionnaire
Time frame: 12 months
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 21 Dec 2018.
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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.
Ipsen Medical Director study director
Ipsen
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Ipsen at 14 sites in Spain.
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 2 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 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. 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?
Quality of life evolution, using the validated Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) (time frame: 12 months). 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 21 Dec 2018.