Advanced Prostate CancerProComDNCT02234089
Therapy Pathways in the Treatment of Hormone Naïve Prostate Cancer Patients With and Without Comorbidities Treated With Degarelix or Luteinizing-Hormone-Releasing-Hormone (LHRH) Agonists.
An observational study of Advanced Prostate Cancer, run by Ferring Pharmaceuticals at 1 site in Germany.
Trial summary
The purpose of this study is to detect factors influencing decision making for treatment pathways of hormone-naïve prostate cancer patients with and without comorbidities receiving medicinal androgen deprivation therapy (Degarelix or LHRH agonists). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Advanced Prostate Cancer
- What is being tested?
- Degarelix and LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)
- How many people
- 461 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to 30 Jun 2019
- 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: Patients with advanced prostate cancer where a treatment decision on therapy has already been made according to medical practice.
Who may be able to join
- Diagnosed with Prostate Cancer and indicated for ADT according to Summary of Product Characteristics (SmPC)
- Decision made to prescribe ADT (Degarelix or LHRH agonist) prior to enrolment
Who cannot join
- Patient had previous or is currently under hormonal management of Prostate Cancer, except for a curative intention, where the duration of the neoadjuvant/adjuvant therapy did not exceed 6 months and treatment should have been terminated at least 6 months prior to baseline.
- Participation in a clinical trial at baseline and during the follow-up period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Investigational site (there may be other sites in this country)
Rottweil
About this study
The purpose of this study is to detect factors influencing decision making for treatment pathways of hormone-naïve prostate cancer patients with and without comorbidities receiving medicinal androgen deprivation therapy (Degarelix or LHRH agonists).
- Conditions
- Advanced Prostate Cancer
- Being tested
- Degarelix, LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
Also called Firmagon®
According to medical practice
LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)Drug
According to medical practice
| Study group | Role | What they receive |
|---|---|---|
| Degarelix | Not described Receives: Drug: Degarelix | |
| LHRH agonist | Not described Receives: Drug: LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of urologist's knowledge of patients' medical history at the point of decision making and during Androgen Deprivation Therapy (ADT)
Measured by questionnaires by quantifying the frequency of urologists' entries
Measured: Up to 4 years
Level of urologist's knowledge of patients' comorbidities at the point of decision making and during ADT
Measured by questionnaires by quantifying the frequency of urologists' entries
Measured: Up to 4 years
Level of urologist's knowledge of patients' concomitant medications at the point of decision making and during ADT
Measured by questionnaires by quantifying the frequency of urologists' entries
Measured: Up to 4 years
Level of urologist's knowledge of patients' risk factors at the point of decision making and during ADT
Measured by questionnaires by quantifying the frequency of urologists' entries
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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 Advanced 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
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234089
- Sponsor's protocol ID
- 000156
- Acronym
- ProComD
- Status last verified
- Jul 2019
- First submitted
- 20 Aug 2014
- Last updated
- 5 Jul 2019
- Results posted
- No
Publications
Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
PubMed 34350976
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy Pathways in the Treatment of Hormone Naïve Prostate Cancer Patients With and Without Comorbidities Treated With Degarelix or Luteinizing-Hormone-Releasing-Hormone (LHRH) Agonists.
- ClinicalTrials.gov ID
- NCT02234089
- Acronym / sponsor ID
- ProComD / 000156
- Conditions
- Advanced Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 9 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 study is to detect factors influencing decision making for treatment pathways of hormone-naïve prostate cancer patients with and without comorbidities receiving medicinal androgen deprivation therapy (Degarelix or LHRH agonists).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Degarelix | – | Drug: Degarelix |
| LHRH agonist | – | Drug: LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced prostate cancer where a treatment decision on therapy has already been made according to medical practice.
Key inclusion criteria (2 listed)
- Diagnosed with Prostate Cancer and indicated for ADT according to Summary of Product Characteristics (SmPC)
- Decision made to prescribe ADT (Degarelix or LHRH agonist) prior to enrolment
Key exclusion criteria (2 listed)
- Patient had previous or is currently under hormonal management of Prostate Cancer, except for a curative intention, where the duration of the neoadjuvant/adjuvant therapy did not exceed 6 months and treatment should have been terminated at least 6 months prior to baseline.
- Participation in a clinical trial at baseline and during the follow-up period
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 |
|---|---|---|
| DegarelixAlso: Firmagon®According to medical practice | Drug | Degarelix |
| LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)According to medical practice | Drug | LHRH agonist |
Primary outcome
Level of urologist's knowledge of patients' medical history at the point of decision making and during Androgen Deprivation Therapy (ADT)
Time frame: Up to 4 years
Measured by questionnaires by quantifying the frequency of urologists' entries
Level of urologist's knowledge of patients' comorbidities at the point of decision making and during ADT
Time frame: Up to 4 years
Measured by questionnaires by quantifying the frequency of urologists' entries
Level of urologist's knowledge of patients' concomitant medications at the point of decision making and during ADT
Time frame: Up to 4 years
Measured by questionnaires by quantifying the frequency of urologists' entries
Level of urologist's knowledge of patients' risk factors at the point of decision making and during ADT
Time frame: Up to 4 years
Measured by questionnaires by quantifying the frequency of urologists' entries
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 5 Jul 2019.
- Derived from this study: PubMed 34350976Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
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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.
Global Clinical Compliance study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Prostate Cancer, run by Ferring Pharmaceuticals at 1 site in Germany.
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 2 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Level of urologist's knowledge of patients' medical history at the point of decision making and during Androgen Deprivation Therapy (ADT) (time frame: Up to 4 years). The study lists 4 primary outcomes in all. 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 NCT02234089, 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 5 Jul 2019.