Prostate CancerANARENNCT03017313
To Evaluate the Criteria for Renewal of Luteinizing Hormone-Releasing Hormone (LHRH) Analogue Treatment in Prostate Cancer Patients
An observational study of Prostate Cancer, run by Ipsen at 27 sites in Spain.
Trial summary
The purpose of the study, is to determine the percentage of patients for whom the initial LHRH prescription has been renewed Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- LHRH analogues
- How many people
- 510 participants
- Where
- 27 sitesSpain
- Study dates
- 13 Jul 2017to 14 Jun 2021
- 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: Patients with Prostate cancer locally advanced or metastatic
Who may be able to join
- Adult men diagnosed of locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy with a 3 or 6 month LHRH analogue including those requiring neo-adjuvant or adjuvant androgen deprivation therapy in association with radiotherapy
- Patients having provided written informed consent
- Patients mentally fit for completing a self-administrated questionnaire
Who cannot join
- Patients participating in another clinical study at the time of inclusion
- Patients with another severe malignant disease
- Life expectancy of less than 12 months
- Patients already treated with a LHRH analogue within the last year
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Spain27 sites
Hospital A Coruña
A Coruña, 15006
Hospital del Sureste
Arganda, 28500
Hospital San Agustín
Avilés, 33401
Hospital de Txagorritxu
Barakaldo, 48902
Hospital de Basurto
Bilbao, 48902
Hospital Gral. Univ. Santa Lucía
Cartagena, 30202
Hospital Arquitecto Marcide
Ferrol, 15405
Hospital Univ. de Getafe
Getafe, 28905
Hospital de Cabueñes
Gijón, 33394
Hospital Universitario Dr Negrín
Las Palmas de Gran Canaria, 35010
Hospital de León
León, 37007
Hospital de la Princesa
Madrid, 28006
Hospital Univ. La Paz
Madrid, 28046
Hospital Univ. Infanta Sofía
Madrid, 28703
Hospital de Torrejón
Madrid, 28850
Hospital Rey Juan Carlos
Madrid, 28933
Hospital Comarcal Santiago Apóstol
Miranda de Ebro, 34004
Hospital Uni. Virgen de la Arrixaca
Murcia, 30120
Hospital Ntra. Señora del Cristal
Ourense, 36312
Hospital Son Llàtzer
Palma, 08003
Hospital Virgen del Camino
Pamplona, 31008
Hospital de Montecelo
Pontevedra, 36312
Hospital Univ. de Salamanca
Salamanca, 37007
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320
Hospital Clínico de Santiago
Santiago de Compostela, 15706
Hospital Clínico de Valladolid
Valladolid, 47005
Hospital Álvaro Cunqueiro
Vigo, 36312
About this study
Official title: A Prospective Post Marketing Non Interventional Study to Evaluate the Criteria on Which Renewal of LHRH Analogue Treatment is Made in Patients With Prostate Cancer Locally Advanced or Metastatic.
The purpose of the study, is to determine the percentage of patients for whom the initial LHRH prescription has been renewed
- Conditions
- Prostate Cancer
- Being tested
- LHRH analogues
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHRH analoguesDrug
3-or 6-month formulations
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients for whom the initial LHRH prescription (the prescription at the baseline visit) has been renewed at first follow-up visit (same type, same formulation).
Measured: First follow-up visit (occurs 3 to 6 months from baseline)
Secondary outcomes (9)
Percentage of patients for whom the initial LHRH prescription has been renewed at each visit.
Measured: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Percentage of patients having switched from a 3 months to a 6 months and also 6 months to 3 months formulation at each visit.
Measured: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Percentage of patients starting a 6-month formulation at baseline.
The decision to prescribe a LHRH analogue as a 3- or 6-months formulation will be made prior to and independently from the decision to enroll the subject. This decision should be made in accordance with the usual medical practice of the concerned investigator.
Measured: Baseline
Reasons leading to a switch from a 3 months to a 6 months formulation (patient) presented as proportion of patients
Measured: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Reasons leading to a switch from a 3 months to a 6 months formulation (physician) presented as proportion of physicians
Measured: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status.
Measured: Baseline
Change of the Quality of Life Questionnaire QLQ-PR25 score compared to baseline and each visit.
Measured: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Correlation between physician and patient satisfaction and the evolution of the biological parameters (Prostate-specific antigen)
Measured: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Percentage of patients for which the initial prescription (the prescription at the baseline visit) of a LHRH analogue (3 or 6 months) has been stopped and later on renewed (intermittent treatment)
Measured: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start13 Jul 2017
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 510 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
- NCT03017313
- Sponsor's protocol ID
- A-ES-52014-224
- Acronym
- ANAREN
- Status last verified
- Jun 2021
- First submitted
- 30 Dec 2016
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. 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 Criteria on Which Renewal of LHRH Analogue Treatment is Made in Patients With Prostate Cancer Locally Advanced or Metastatic.
- ClinicalTrials.gov ID
- NCT03017313
- Acronym / sponsor ID
- ANAREN / A-ES-52014-224
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 11 Jan 2017 (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 the study, is to determine the percentage of patients for whom the initial LHRH prescription has been renewed
Study design
- Observational model
- Cohort
- 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
- Patients with Prostate cancer locally advanced or metastatic
Key inclusion criteria (3 listed)
- Adult men diagnosed of locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy with a 3 or 6 month LHRH analogue including those requiring neo-adjuvant or adjuvant androgen deprivation therapy in association with radiotherapy
- Patients having provided written informed consent
- Patients mentally fit for completing a self-administrated questionnaire
Key exclusion criteria (4 listed)
- Patients participating in another clinical study at the time of inclusion
- Patients with another severe malignant disease
- Life expectancy of less than 12 months
- Patients already treated with a LHRH analogue within the last year
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 |
|---|---|---|
| LHRH analogues3-or 6-month formulations | Drug | – |
Primary outcome
Percentage of patients for whom the initial LHRH prescription (the prescription at the baseline visit) has been renewed at first follow-up visit (same type, same formulation).
Time frame: First follow-up visit (occurs 3 to 6 months from baseline)
9 secondary outcomes
Percentage of patients for whom the initial LHRH prescription has been renewed at each visit.
Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Percentage of patients having switched from a 3 months to a 6 months and also 6 months to 3 months formulation at each visit.
Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Percentage of patients starting a 6-month formulation at baseline.
Time frame: Baseline
Reasons leading to a switch from a 3 months to a 6 months formulation (patient) presented as proportion of patients
Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Reasons leading to a switch from a 3 months to a 6 months formulation (physician) presented as proportion of physicians
Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status.
Time frame: Baseline
Change of the Quality of Life Questionnaire QLQ-PR25 score compared to baseline and each visit.
Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Correlation between physician and patient satisfaction and the evolution of the biological parameters (Prostate-specific antigen)
Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Percentage of patients for which the initial prescription (the prescription at the baseline visit) of a LHRH analogue (3 or 6 months) has been stopped and later on renewed (intermittent treatment)
Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 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 24 Jun 2021.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
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.
Ipsen Medical Director study director
Ipsen
27 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 27 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 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 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
Percentage of patients for whom the initial LHRH prescription (the prescription at the baseline visit) has been renewed at first follow-up visit (same type, same formulation). (time frame: First follow-up visit (occurs 3 to 6 months from baseline)). 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 24 Jun 2021.