Prostate CancerNCT02236637
A Registry to Observe the Treatment of Prostate Cancer Under Routine Medical Care
An observational study of Prostate Cancer, run by Janssen Pharmaceutica N.V., Belgium at 146 sites in 15 countries.
Trial summary
The purpose of this registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used. 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
- 3,050 participants
- Where
- 146 sitesin 15 countries
- Study dates
- 14 Jun 2013to 21 Nov 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 3,000 patients will be enrolled in this registry. Patients eligible for enrollment will be men aged at least 18 years, with a confirmed diagnosis of adenocarcinoma of the prostate, with documented metastatic prostate cancer and documented castration resistance. Patients will be enrolled at the time of initiating a new systemic anticancer mCRPC treatment or during surveillance; for the purpose of the registry, at enrollment, initiation of a new systemic mCRPC treatment is considered as ±30 days from a patient's baseline data collection.
Who may be able to join
- Patients with a histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate Patients with documented metastatic prostate cancer Patients with documented castration resistance Patients either: Initiating a new systemic mCRPC treatment; or considered to be in surveillance according to clinical practice Sign (or their legally-acceptable representatives must sign) a participation agreement or informed consent form (ICF), per local regulations.
Who cannot join
- Any patient who is withdrawn from the registry for any reason may not re-enter the registry
Trial locations and contacts
146 sites in 15 countries.
146 sites in 15 countries
Germany25 sites
Study site
Augsburg
Study site
Bad Saarow
Study site
Bautzen
Study site
Berlin
Study site
Braunschweig
Study site
Chemnitz
Study site
Duisburg
Study site
Erkrath
Study site
Frankfurt
Study site
Hamburg
Study site
Holzminden
Study site
Jena
Study site
Kiel
Study site
Kirchheim
Study site
Nürtingen
Study site
Remscheid
Study site
Reutlingen
Study site
Rostock
Study site
Schwerin
Study site
Sindelfingen
Study site
Tübingen
Study site
Ulm
Study site
Weiden
Study site
Wilhelmshaven
Study site
Würselen
France22 sites
Study site
Angers
Study site
Avignon
Study site
Béziers
Study site
Brest
Study site
Gap
Study site
Hyères
Study site
La Tronche
Study site
Marseille
Study site
Metz
Study site
Montpellier
Study site
Nancy
Study site
Paris
Study site
Périgueux
Study site
Pierre-Bénite
Study site
Pringy
Study site
Reims
Study site
Rennes
Study site
Saint-Grégoire
Study site
Saint-Mandé
Study site
Saint-Quentin
Study site
Toulouse
Study site
Tours
United Kingdom22 sites
Study site
Ashton-under-Lyne
Study site
Barnstaple
Study site
Blackburn
Study site
Bournemouth
Study site
Bradford
Study site
Brighton Sussex
Study site
Burton
Study site
Crewe
Study site
Huddersfield
Study site
Lancaster
Study site
Leeds Yorks
Study site
London
Study site
N/a N/a
Study site
Plymouth
Study site
Scunthorpe
Study site
Steeton
Study site
Stoke-on-Trent
Study site
Taunton
Study site
Torquay
Study site
Wakefield
Study site
Wigan
Study site
York
Spain14 sites
Study site
A Coruña
Study site
Asturias
Study site
Barakaldo Vizcaya
Study site
Barcelona
Study site
Bilbao Vizcaya
Study site
Girona
Study site
Langreo
Study site
Palma de Mallorca
Study site
Pontevedra
Study site
Sabadell
Study site
Salamanca
Study site
Santiago de Compostela
Study site
Valladolid
Study site
Zaragoza
Belgium13 sites
Study site
Aalst
Study site
Antwerp
Study site
Bonheiden
Study site
Brasschaat
Study site
Bruges
Study site
Edegem
Study site
Ghent
Study site
Kortrijk
Study site
Liège
Study site
Ostend
Study site
Ottignies
Study site
Roeselare
Study site
Turnhout
Sweden9 sites
Study site
Borås
Study site
Gothenburg
Study site
Malmö
Study site
Örebro
Study site
Östersund
Study site
Stockholm
Study site
Umeå
Study site
Västerås
Study site
Vaxjo
Poland7 sites
Study site
Bydgoszcz
Study site
Gdynia
Study site
Krakow
Study site
Lodz
Study site
Opole
Study site
Poznañ
Study site
Warsaw
Russia7 sites
Study site
Moscow
Study site
Obninsk
Study site
Omsk
Study site
Rostov-on-Don
Study site
Saint Petersburg
Study site
Ufa
Study site
Yekaterinburg
Turkey (Türkiye)7 sites
Study site
Ankara
Study site
Edirne
Study site
Istanbul
Study site
Izmir
Study site
Kayseri
Study site
Kocaeli
Study site
Turkey
Portugal6 sites
Study site
Braga
Study site
Coimbra
Study site
Evora
Study site
Lisbon
Study site
Porto
Study site
Setúbal
Israel5 sites
Study site
Beer Yaakov
Study site
Beersheba
Study site
Haifa
Study site
Holon
Study site
Tel Aviv
Slovenia3 sites
Study site
Celje
Study site
Ljubljana
Study site
Slovenj Gradec
About this study
Official title: A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer
The purpose of this registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments, there is a need for a current and improved understanding of how these treatments fit into the current treatment paradigm for mCRPC, how they are combined and sequenced, and how their relative effectiveness profiles emerge outside of a clinical trial setting. This will be based on documentation and description of sequencing of treatment initiation, termination, and duration; relative effectiveness of treatments; defined medical resource utilization (MRU) and quality-of-life parameters and follow-up for survival.
Read the detailed description
This is a non-interventional, multicenter, prospective registry of patients with a confirmed diagnosis of adenocarcinoma of the prostate presenting with mCRPC, based on documented metastatic prostate cancer and documented castration resistance. Castrate-resistant prostate cancer is defined by disease progression despite testosterone <50 ng/dL, and/or androgen deprivation therapy, and/or a history of orchiectomy, and may present as a continuous rise in prostate-specific antigen (PSA), and/or worsening of existing disease/symptoms, and/or the appearance of new metastases. Observational methodology will be used to capture data. The decision of patients to take part in the registry will not influence their medical care. Treatment decisions will be made at the discretion of the treating physician, per routine clinical practice. Only data available from routine clinical practice will be collected. It is expected that approximately 3,000 patients will participate in this registry. To ensure a patient population representative of clinical practice and to reduce selection bias, all patients meeting the eligibility criteria at a participating site should be consecutively enrolled in the registry, irrespective of their treatment. The planned total duration of the registry will be 5.5 years from the date that the first patient is enrolled, irrespective of the country or registry site. The anticipated duration of patient enrollment is 2.5 years. The maximum duration of follow-up for individual patients in the observational period of the registry will be 3 years, regardless of when they are enrolled. The 3-year period of the observational period will document the sequencing of systemic mCRPC treatments during routine clinical practice, considering the life expectancy of patients with mCRPC in the registry. Unless specified otherwise per local regulations, all patients must give their informed consent to participate in this registry before data collection (ie, data entry into the case report form [CRF]) is performed. Patients will be enrolled at the time of initiation of a new systemic mCRPC treatment or during a period when a patient is considered to be in surveillance according to clinical practice. Baseline data collection will include details of the patient's prostate cancer history and prior prostate cancer treatment. This will be followed by a prospective observational period during which patients may cycle through multiple systemic mCRPC treatment periods and periods of surveillance. During the observational period, data will be collected at the following time points of a patient's course of treatment in routine clinical practice: initiation of a new systemic mCRPC treatment; termination of a systemic mCRPC treatment; when the duration of a systemic mCRPC treatment or surveillance period is >3 months, data collection will be performed at a minimum frequency of 3-monthly intervals during that period. Survival data will be collected for all patients 3 years after their enrollment or at the close of the registry, whichever occurs first, except for those patients who withdraw their consent prior to completing the observation period.
- Conditions
- Prostate Cancer
- Keywords
- Adenocarcinoma of the Prostate, Registry, metastatic castration-resistant prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mCRPC patients | Patients with metastatic castration-resistant prostate cancer treated according to routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequencing of treatment initiation, termination, and duration
During the registry all systemic mCRPC therapies, corticoids for systemic use in the context of prostate cancer treatment and local mCRPC therapies, including but not limited to urologic surgery, orthopaedic surgery, and local radiotherapy, will be documented.
Measured: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Secondary outcomes (9)
Clinical Benefit
Clinical benefit will be based on the Eastern Cooperative Oncology Group (ECOG) performance status, which measure the patient status on a scale from 0 (fully active) to 5 (dead).
Measured: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Medical Resource Utilization
Total number of days of hospitalization due to prostate cancer, or treatment of the disease, total number of visits to an emergency room due to prostate cancer, or treatment of the disease, and total number of outpatient visits due to prostate cancer, or treatment of the disease
Measured: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
European Quality of Life-5 Dimensions, 5 Levels Questionnaire (EQ-5D-(5L))
The EQ-5D-5L is an instrument for measuring health status. It consists of the descriptive system and the EQ visual Analogue scale (EQ VAS). The descriptive system comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). There are 5 levels for each dimension: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'.
Measured: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P)
The FACT-P consists of the FACT-General (FACT-G) and a prostate cancer subscale. The FACT-G (Version 4) contains a 27-item questionnaire and is composed of 4 subscales of health-related quality-of-life: physical well-being, social/family well-being, emotional well being, and functional well-being. The prostate cancer subscale is composed of 12 items, related to prostate-specific questions, which include sexuality, bowel/bladder function, and pain. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to 156; a higher score indicates better QOL
Measured: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Overall Survival
Measured: At treatment initiation/termination or every 3 months from baseline to 3 years
Radiologic Assessment
Radiologic assessment methodology and radiologic response will be documented. Prostate Cancer Working Group 2 (PCWG2) and Response Evaluation Criteria In Solid Tumor (RECIST) are recommended guidelines for assessment.
Measured: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Prior prostate cancer treatment
Prior prostate cancer treatment (local and systemic therapy) from the time of diagnosis of prostate cancer to entry in the registry will be recorded.
Measured: At baseline
Reason for start and rationale for choice of treatment
Measured: At treatment initiation during maximum 3 years
Reason for treatment discontinuation
Measured: At treatment discontinuation during maximum 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study start14 Jun 2013
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236637
- Sponsor's protocol ID
- CR100857
- Other IDs
- 212082PCR4001
- Status last verified
- Nov 2019
- First submitted
- 8 Sep 2014
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Verry C, Vincendeau S, Massetti M, Blachier M, Vimont A, Bazil ML, Bernardini P, Pettre S, Timsit MO. Pattern of Clinical Progression Until Metastatic Castration-Resistant Prostate Cancer: An Epidemiological Study from the European Prostate Cancer Registry. Target Oncol. 2022 Jul;17(4):441-451. doi: 10.1007/s11523-022-00899-6. Epub 2022 Jul 16.
PubMed 35841526Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaeth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L, Chowdhury S. Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry. Target Oncol. 2021 May;16(3):357-367. doi: 10.1007/s11523-021-00807-4. Epub 2021 Apr 7.
PubMed 33826036Chowdhury S, Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaeth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry. Target Oncol. 2020 Jun;15(3):301-315. doi: 10.1007/s11523-020-00720-2.
PubMed 32500294
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02236637
- Acronym / sponsor ID
- CR100857
- Conditions
- Prostate Cancer
- Keywords
- Adenocarcinoma of the Prostate, Registry, metastatic castration-resistant prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,050 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2013 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 10 Sep 2014 (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 registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments, there is a need for a current and improved understanding of how these treatments fit into the current treatment paradigm for mCRPC, how they are combined and sequenced, and how their relative effectiveness profiles emerge outside of a clinical trial setting. This will be based on documentation and description of sequencing of treatment initiation, termination, and duration; relative effectiveness of treatments; defined medical resource utilization (MRU) and quality-of-life parameters and follow-up for survival.
Detailed description
This is a non-interventional, multicenter, prospective registry of patients with a confirmed diagnosis of adenocarcinoma of the prostate presenting with mCRPC, based on documented metastatic prostate cancer and documented castration resistance. Castrate-resistant prostate cancer is defined by disease progression despite testosterone <50 ng/dL, and/or androgen deprivation therapy, and/or a history of orchiectomy, and may present as a continuous rise in prostate-specific antigen (PSA), and/or worsening of existing disease/symptoms, and/or the appearance of new metastases. Observational methodology will be used to capture data. The decision of patients to take part in the registry will not influence their medical care. Treatment decisions will be made at the discretion of the treating physician, per routine clinical practice. Only data available from routine clinical practice will be collected. It is expected that approximately 3,000 patients will participate in this registry. To ensure a patient population representative of clinical practice and to reduce selection bias, all patients meeting the eligibility criteria at a participating site should be consecutively enrolled in the registry, irrespective of their treatment. The planned total duration of the registry will be 5.5 years from the date that the first patient is enrolled, irrespective of the country or registry site. The anticipated duration of patient enrollment is 2.5 years. The maximum duration of follow-up for individual patients in the observational period of the registry will be 3 years, regardless of when they are enrolled. The 3-year period of the observational period will document the sequencing of systemic mCRPC treatments during routine clinical practice, considering the life expectancy of patients with mCRPC in the registry. Unless specified otherwise per local regulations, all patients must give their informed consent to participate in this registry before data collection (ie, data entry into the case report form [CRF]) is performed. Patients will be enrolled at the time of initiation of a new systemic mCRPC treatment or during a period when a patient is considered to be in surveillance according to clinical practice. Baseline data collection will include details of the patient's prostate cancer history and prior prostate cancer treatment. This will be followed by a prospective observational period during which patients may cycle through multiple systemic mCRPC treatment periods and periods of surveillance. During the observational period, data will be collected at the following time points of a patient's course of treatment in routine clinical practice: initiation of a new systemic mCRPC treatment; termination of a systemic mCRPC treatment; when the duration of a systemic mCRPC treatment or surveillance period is >3 months, data collection will be performed at a minimum frequency of 3-monthly intervals during that period. Survival data will be collected for all patients 3 years after their enrollment or at the close of the registry, whichever occurs first, except for those patients who withdraw their consent prior to completing the observation period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mCRPC patients | – | –Patients with metastatic castration-resistant prostate cancer treated according to routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 3,000 patients will be enrolled in this registry. Patients eligible for enrollment will be men aged at least 18 years, with a confirmed diagnosis of adenocarcinoma of the prostate, with documented metastatic prostate cancer and documented castration resistance. Patients will be enrolled at the time of initiating a new systemic anticancer mCRPC treatment or during surveillance; for the purpose of the registry, at enrollment, initiation of a new systemic mCRPC treatment is considered as ±30 days from a patient's baseline data collection.
Key inclusion criteria (1 listed)
- Patients with a histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate Patients with documented metastatic prostate cancer Patients with documented castration resistance Patients either: Initiating a new systemic mCRPC treatment; or considered to be in surveillance according to clinical practice Sign (or their legally-acceptable representatives must sign) a participation agreement or informed consent form (ICF), per local regulations.
Key exclusion criteria (1 listed)
- Any patient who is withdrawn from the registry for any reason may not re-enter the registry
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
Sequencing of treatment initiation, termination, and duration
Time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
During the registry all systemic mCRPC therapies, corticoids for systemic use in the context of prostate cancer treatment and local mCRPC therapies, including but not limited to urologic surgery, orthopaedic surgery, and local radiotherapy, will be documented.
9 secondary outcomes
Clinical Benefit
Time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Medical Resource Utilization
Time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
European Quality of Life-5 Dimensions, 5 Levels Questionnaire (EQ-5D-(5L))
Time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P)
Time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Overall Survival
Time frame: At treatment initiation/termination or every 3 months from baseline to 3 years
Radiologic Assessment
Time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Prior prostate cancer treatment
Time frame: At baseline
Reason for start and rationale for choice of treatment
Time frame: At treatment initiation during maximum 3 years
Reason for treatment discontinuation
Time frame: At treatment discontinuation during maximum 3 years
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 12 Nov 2019.
- Derived from this study: PubMed 35841526Verry C, Vincendeau S, Massetti M, Blachier M, Vimont A, Bazil ML, Bernardini P, Pettre S, Timsit MO. Pattern of Clinical Progression Until Metastatic Castration-Resistant Prostate Cancer: An Epidemiological Study from the European Prostate Cancer Registry. Target Oncol. 2022 Jul;17(4):441-451. doi: 10.1007/s11523-022-00899-6. Epub 2022 Jul 16.
- Derived from this study: PubMed 33826036Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaeth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L, Chowdhury S. Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry. Target Oncol. 2021 May;16(3):357-367. doi: 10.1007/s11523-021-00807-4. Epub 2021 Apr 7.
- Derived from this study: PubMed 32500294Chowdhury S, Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaeth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry. Target Oncol. 2020 Jun;15(3):301-315. doi: 10.1007/s11523-020-00720-2.
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.
The record lists no contact. Use the official record to reach the sponsor.
146 sites in 15 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 Janssen Pharmaceutica N.V., Belgium at 146 sites in 15 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 1 inclusion and 1 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 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 146 sites in Germany, France, United Kingdom, Spain, Belgium and 10 more countries. 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?
Sequencing of treatment initiation, termination, and duration (time frame: At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years). 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 NCT02236637, which also lists 3 linked publications.
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 12 Nov 2019.