Prostate CancerANALUTSNCT02542501
Study to Evaluate the Presence of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Scheduled to Receive Luteinizing Hormone Releasing Hormone (LHRH) Analogues
An observational study of Prostate Cancer, run by Ipsen at 32 sites in 2 countries.
Trial summary
The intention of this study is to investigate how many patients with prostate cancer, planned to be treated with LHRH analogues without history of surgery or radiotherapy, are suffering from LUTS. In addition the effect of LHRH analogues on the improvement of theses primary LUTS symptoms over time will be investigated. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 470 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Jul 2015to 21 Jul 2018
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Community sample
Who may be able to join
- Adult men with locally advanced or metastatic prostate cancer scheduled to receive LHRH analogues. A patient who has completed an IPSS questionnaire in his last visit, before the start of LHRH analogues, will be able to participate in the study. This last visit has to be done 6 months before the baseline visit.
- Patients having provided written informed consent
- Patients mentally fit for completing a self-administered questionnaire
Who cannot join
- Any surgical or radiotherapy treatment performed at prostate level before the entry of the study
- Patient with castrate levels of testosterone ( < 50 ng/dL) at his first IPSS questionnaire
- Patients who are also participating in any other clinical study within the last 2 months before study entry
- Life expectancy of less than 12 months
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
Spain27 sites
Hospital Universitario A Coruña
A Coruña, 15006
Hospital Sureste
Arganda, Madrid, 28500
Hospital Germans Trias I Pujol
Badalona, 08916
H. del Mar
Barcelona, 08003
H. Valle Hebrón
Barcelona, 08035
Hospital de Basurto
Bilbao, 48013
Hospital de Ciudad Real
Ciudad Real, 13005
Hospital Getafe
Getafe, 28905
H. Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital de León
León, 24008
Hospital de la Princesa
Madrid, 28006
Hospital Univ. La Paz
Madrid, 28046
Hospital del Sureste, Arganda de Rey
Madrid, 28500
Hospital Althaia
Manresa, 08243
H. Parc Tauli
Sabadell, 08208
Hospital de Salamanca
Salamanca, 37007
Hospital de Donosti
San Sebastián, 20014
Hospital Infanta Sofía
San Sebastián de los Reyes, 28702
Hospital Esperit Sant
Santa Coloma de Gramenet, Barcelona, 08923
H. Univ. Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, 38010
Complejo Clínico Universitario de Santiago
Santiago de Compostela, 15706
Hospital Joan XXIII
Tarragona, 430005
Hospital Clínico de Valladolid
Valladolid, 47003
Hospital Universitari de Vic
Vic, 08500
H. Do Meixoeiro
Vigo, 36200
Hospital Santiago Apóstol
Vitoria-Gasteiz, 01004
Hospital de Txagorritxu
Vitoria-Gasteiz, 01009
Portugal5 sites
Hospital Universitário de Coimbra
Coimbra, 3000-075
Hospital de São José
Lisbon, 1150-199
Hospital de Santa Maria
Lisbon, 1649-035
Hospital Pedro Hispano
Matosinhos Municipality, 4454-509
Hospital Geral de Santo António
Porto, 4099-001
About this study
Official title: A Prospective Post Marketing Non Interventional Study to Evaluate the Presence of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Scheduled to Receive LHRH Analogues and to Evaluate the Effect of LHRH Analogues on Lower Urinary Tract Symptoms (ANALUTS Study)
The intention of this study is to investigate how many patients with prostate cancer, planned to be treated with LHRH analogues without history of surgery or radiotherapy, are suffering from LUTS. In addition the effect of LHRH analogues on the improvement of theses primary LUTS symptoms over time will be investigated.
- 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.
The number of patients having Lower Urinary Tract Symptoms (LUTS) at baseline.
Measured: Baseline
The percentage of patients suffering from prostate cancer with moderate to severe LUTS (International prostate symptom score (IPSS) >7) at baseline and having at least 3 points reduction of IPSS score at the end of study (48 weeks).
Measured: Week 48
Secondary outcomes (5)
The percentage of patients suffering from prostate cancer with moderate to severe LUTS (score IPSS > 7) at baseline and having at least 3 points reduction of IPSS score at week 24.
Measured: Week 24
The correlation between IPSS score changes and total prostatic-specific antigen (PSA) changes after 24 weeks of treatment compared to baseline in patients with non-operable prostate cancer presenting moderate to severe LUTS (score IPSS >7) at baseline.
Assessed with the Pearson correlation coefficient
Measured: Week 24
The correlation between IPSS score changes and total PSA changes after 48 weeks of treatment compared to baseline in patients with non-operable prostate cancer presenting moderate to severe LUTS (score IPSS >7).
Assessed with the Pearson correlation coefficient
Measured: Week 48
Comparison of the percentage of patients presenting an IPSS ≥ 3 at week 24 to the percentage of patients presenting an IPSS ≥ 3 at baseline.
Assessed with the McNemar's test
Measured: Week 24
Comparison of the percentage of patients presenting an IPSS ≥ 3 at week 48 to the percentage of patients presenting an IPSS ≥ 3 at baseline.
Assessed with the McNemar's test
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJul 2015
- Primary completion21 Jul 2018
- Study completion21 Jul 2018
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 only
- Time perspective
- Prospective
- Enrolment
- 470 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
- NCT02542501
- Sponsor's protocol ID
- A-ES-52014-219
- Acronym
- ANALUTS
- Status last verified
- Dec 2018
- First submitted
- 7 Jul 2015
- 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
- A Prospective Post Marketing Non Interventional Study to Evaluate the Presence of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Scheduled to Receive LHRH Analogues and to Evaluate the Effect of LHRH Analogues on Lower Urinary Tract Symptoms (ANALUTS Study)
- ClinicalTrials.gov ID
- NCT02542501
- Acronym / sponsor ID
- ANALUTS / A-ES-52014-219
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- 21 Jul 2018 (actual)
- Study completion
- 21 Jul 2018 (actual)
- First posted
- 7 Sep 2015 (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 intention of this study is to investigate how many patients with prostate cancer, planned to be treated with LHRH analogues without history of surgery or radiotherapy, are suffering from LUTS. In addition the effect of LHRH analogues on the improvement of theses primary LUTS symptoms over time will be investigated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (3 listed)
- Adult men with locally advanced or metastatic prostate cancer scheduled to receive LHRH analogues. A patient who has completed an IPSS questionnaire in his last visit, before the start of LHRH analogues, will be able to participate in the study. This last visit has to be done 6 months before the baseline visit.
- Patients having provided written informed consent
- Patients mentally fit for completing a self-administered questionnaire
Key exclusion criteria (4 listed)
- Any surgical or radiotherapy treatment performed at prostate level before the entry of the study
- Patient with castrate levels of testosterone ( < 50 ng/dL) at his first IPSS questionnaire
- Patients who are also participating in any other clinical study within the last 2 months before study entry
- Life expectancy of less than 12 months
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
The number of patients having Lower Urinary Tract Symptoms (LUTS) at baseline.
Time frame: Baseline
The percentage of patients suffering from prostate cancer with moderate to severe LUTS (International prostate symptom score (IPSS) >7) at baseline and having at least 3 points reduction of IPSS score at the end of study (48 weeks).
Time frame: Week 48
5 secondary outcomes
The percentage of patients suffering from prostate cancer with moderate to severe LUTS (score IPSS > 7) at baseline and having at least 3 points reduction of IPSS score at week 24.
Time frame: Week 24
The correlation between IPSS score changes and total prostatic-specific antigen (PSA) changes after 24 weeks of treatment compared to baseline in patients with non-operable prostate cancer presenting moderate to severe LUTS (score IPSS >7) at baseline.
Time frame: Week 24
The correlation between IPSS score changes and total PSA changes after 48 weeks of treatment compared to baseline in patients with non-operable prostate cancer presenting moderate to severe LUTS (score IPSS >7).
Time frame: Week 48
Comparison of the percentage of patients presenting an IPSS ≥ 3 at week 24 to the percentage of patients presenting an IPSS ≥ 3 at baseline.
Time frame: Week 24
Comparison of the percentage of patients presenting an IPSS ≥ 3 at week 48 to the percentage of patients presenting an IPSS ≥ 3 at baseline.
Time frame: Week 48
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
32 sites in 2 countries: 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 32 sites in 2 countries.
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 3 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 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 32 sites in Spain, Portugal. 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 number of patients having Lower Urinary Tract Symptoms (LUTS) at baseline. (time frame: Baseline). The study lists 2 primary outcomes in all. 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.