Prostate CancerLEPTONCT03990194
Real-life Study of Patients After 3-months of Leuprorelin 5mg Implant in Prostate Cancer
An observational study of Prostate Cancer, run by RECORDATI GROUP.
Trial summary
To improve the management of patients suffering from prostate cancer, Laboratoires BOUCHARA-RECORDATI wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and biological follow-up of patients undergoing leuprorelin 5 mg implant as well as the… 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?
- Leuprolide Acetate
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Mar 2020
- 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 for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (Leptoprol®).
Who may be able to join
- Patients with prostate cancer for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (Leptoprol®).
Who cannot join
- Patient who have already participated in another study or those who do not wish to participate in this study.
About this study
Official title: Real-life Observational Study of Patients After 3-months of Leuprorelin 5mg Implant and Evaluation of Coping Strategies Among Patients With Prostate Cancer: LEPTO STUDY
To improve the management of patients suffering from prostate cancer, Laboratoires BOUCHARA-RECORDATI wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and biological follow-up of patients undergoing leuprorelin 5 mg implant as well as the conditions for implant placement. The evolution of these prostate cancer patients will be monitored on the basis of data available in daily practice, including testosterone values, PSA values, and factors that may influence disease progression, in order to objectify whether the observed results are consistent with those described in the clinical studies.
Read the detailed description
To improve the management of patients suffering from prostate cancer, Laboratoires BOUCHARA-RECORDATI wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and biological follow-up of patients undergoing leuprorelin 5 mg implant as well as the conditions for implant placement. The evolution of these prostate cancer patients will be monitored on the basis of data available in daily practice, including testosterone values, PSA values, and factors that may influence disease progression, in order to objectify whether the observed results are consistent with those described in the clinical studies.
The psychological dimension of the management of patients with prostate cancer will also be addressed by evaluating the strategies used by patients to cope with their prostate cancer [(Prostate Cancer Patients' Coping Strategies Questionnaire (PCPCSQ)].
- Conditions
- Prostate Cancer
- Being tested
- Leuprolide Acetate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide AcetateDrug
Also called Leptoprol 5 mg
Administration of Leptoprol implant every 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of prostate cancer patients at 3 months who attained a testosteronemia threshold of ≤ 0.5 ng/mL following a 3-month treatment with leuprorelin 5 mg implant
The percentage of prostate cancer patients who attained a testosteronemia threshold of ≤ 0.5 ng/mL following a 3-month treatment with leuprorelin 5 mg implant will be evaluated at 3 months and at 6 months of follow-up
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Mar 2020
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: Internal decision
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990194
- Sponsor's protocol ID
- Leptoprol- FR-NIS 0023
- Acronym
- LEPTO
- Status last verified
- Sep 2020
- First submitted
- 13 Jun 2019
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Observational Study of Patients After 3-months of Leuprorelin 5mg Implant and Evaluation of Coping Strategies Among Patients With Prostate Cancer: LEPTO STUDY
- ClinicalTrials.gov ID
- NCT03990194
- Acronym / sponsor ID
- LEPTO / Leptoprol- FR-NIS 0023
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Internal decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 18 Jun 2019 (actual)
- 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.
To improve the management of patients suffering from prostate cancer, Laboratoires BOUCHARA-RECORDATI wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and biological follow-up of patients undergoing leuprorelin 5 mg implant as well as the conditions for implant placement. The evolution of these prostate cancer patients will be monitored on the basis of data available in daily practice, including testosterone values, PSA values, and factors that may influence disease progression, in order to objectify whether the observed results are consistent with those described in the clinical studies.
Detailed description
To improve the management of patients suffering from prostate cancer, Laboratoires BOUCHARA-RECORDATI wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and biological follow-up of patients undergoing leuprorelin 5 mg implant as well as the conditions for implant placement. The evolution of these prostate cancer patients will be monitored on the basis of data available in daily practice, including testosterone values, PSA values, and factors that may influence disease progression, in order to objectify whether the observed results are consistent with those described in the clinical studies.
The psychological dimension of the management of patients with prostate cancer will also be addressed by evaluating the strategies used by patients to cope with their prostate cancer [(Prostate Cancer Patients' Coping Strategies Questionnaire (PCPCSQ)].
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 for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (Leptoprol®).
Key inclusion criteria (1 listed)
- Patients with prostate cancer for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (Leptoprol®).
Key exclusion criteria (1 listed)
- Patient who have already participated in another study or those who do not wish to participate in this study.
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 |
|---|---|---|
| Leuprolide AcetateAlso: Leptoprol 5 mgAdministration of Leptoprol implant every 3 months | Drug | – |
Primary outcome
The percentage of prostate cancer patients at 3 months who attained a testosteronemia threshold of ≤ 0.5 ng/mL following a 3-month treatment with leuprorelin 5 mg implant
Time frame: 3 months
The percentage of prostate cancer patients who attained a testosteronemia threshold of ≤ 0.5 ng/mL following a 3-month treatment with leuprorelin 5 mg implant will be evaluated at 3 months and at 6 months of follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by RECORDATI GROUP.
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: withdrawn, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 percentage of prostate cancer patients at 3 months who attained a testosteronemia threshold of ≤ 0.5 ng/mL following a 3-month treatment with leuprorelin 5 mg implant (time frame: 3 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 31 Oct 2024.