Real-life Study of Patients After 3-months of Leuprorelin... | NCT03990194

Studies
Real-life Study of Patients After 3-months of Leuprorelin 5mg Implant in Prostate Cancer

NCT03990194

Sponsor

RECORDATI GROUP

Status

Withdrawn

Last Update Posted

Oct 31, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Leuprolide Acetate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Internal decision

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Mar 1, 2020Actual

First Submitted Date

Jun 13, 2019

First Submission Date that Met QC Criteria

Jun 17, 2019

First Posted Date

Jun 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2024

Last Update Posted Date

Oct 31, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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

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)].

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Leuprolide Acetate	Drug	Administration of Leptoprol implant every 3 months		Leptoprol 5 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with prostate cancer for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (Leptoprol®).

Exclusion Criteria:

Patient who have already participated in another study or those who do not wish to participate in this study.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with prostate cancer for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (Leptoprol®).

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016729	Leuprolide

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided