Observational Program to Assess Use of Intermittent Adjuvant Deprivation Therapy With Leuprorelin (Lucrin Depot) in Patients With Advanced Prostate Cancer (PCa) in Russia

NCT01320735 | Completed Results

• 1 other identifier: P12-763
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study was to describe treatment patterns of leuprorelin over 2 years using an intermittent, adjuvant regimen in participants with advanced prostate cancer (PCa)

Conditions

Prostate Cancer

Keywords

Lucrin Depot; intermittent adjuvant regimen; advanced prostate cancer; Leuprorelin

Outcome Measures

Primary Outcomes (5)

• Mean Duration of Leuprorelin Exposure

  Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation.

  24 months

• Mean Duration of Each Leuprorelin Cycle

  Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation.

  24 months

• Median Number of Leuprorelin Cycles

  The Participants were on IAD regimen and the data are reported as number of cycles with full range.

  24 months

• Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen

  The data are reported as percentage of participants.

  24 months

• Number of Participants Who Switched to IAD Regimen by Visit

  The data are reported as number of participants.

  24 months

Secondary Outcomes (6)

• Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC)

  Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit

• Median Time to Progression of HRPC

  Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit

• Median Time to Progression of HRPC in Participants Not Started on IAD Regimen

  Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit

• Median Survival Time

  Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit

• Mean Duration of Treatment-off Time in IAD Regimen

  Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit

Other Outcomes (3)

• Duration of IAD Regimen Induction Phase

  At least 6-9 months after Baseline (enrollment)

• Number of Participants Who Received IAD Regimen During the Study

  24 months

• Number of Participants Who Continued to Take Leuprorelin in IAD Regimen by the End of the Study

  24 months

Study Arms (1)

Advanced PCa

Participants with advanced PCa

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with advanced PCa

You may qualify if:

• Histologically confirmed advanced PCa meeting the following criteria:
• Any Tumor, Node 1, Metastasis 0
• Any Tumor, Node 0, Metastasis 1 \[according to Tumor Node Metastasis classification 2009\]
• Participants planned for administration of leuprorelin
• World Health Organization status 0-1
• Life expectancy at least 2 years

You may not qualify if:

• Contraindications to administration of leuprorelin:
• Hypersensitivity to Leuprorelin similar products of protein origin or any of the excipients in drug product composition
• Surgical castration
• Hormone-refractory PCa
• Presence of another malignant tumor (except skin cancer)
• Previous administration of hormone therapy with gonadotropin-releasing hormone agonists or antiandrogens
• Previous administration of radiotherapy or chemotherapy course within 1 month
• Extremely high level of PSA (greater than or equal to 1000 ng/ml)
• Other severe diseases in stage of decompensation
• Other contraindications, that make the participant's participation impossible (by investigator judgment)
• Previous enrollment in the present program

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Almedis: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Andrey Strugovshchikov, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: March 22, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 8, 2015
• Results First Posted: July 8, 2015

Record last verified: 2015-06