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Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT01320735 (opens ClinicalTrials.gov in a new tab)Other idP12-763
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Leuprolide, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase not stated
Enrollment
300 participants (actual)
Sponsor
AbbVie (prior sponsor, Abbott) · Industry
Design
Not stated
Countries
Not stated
Start
Feb 2011
Primary completion
May 2014
Completion
May 2014
First posted
22 Mar 2011 (estimated)
Last update posted
8 Jul 2015 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. Ph –

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

    NCT01320735

    Feb 2011 to May 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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)

Arms1

  • Other

    Advanced PCa

    Participants with advanced PCa

Primary outcomes5

Outcomes the sponsor listed as primary.

  1. Mean Duration of Leuprorelin Exposure

    Time frame · 24 months

    Registry description

    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.

  2. Mean Duration of Each Leuprorelin Cycle

    Time frame · 24 months

    Registry description

    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.

  3. Median Number of Leuprorelin Cycles

    Time frame · 24 months

    Registry description

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

  4. Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen

    Time frame · 24 months

    Registry description

    The data are reported as percentage of participants.

  5. Number of Participants Who Switched to IAD Regimen by Visit

    Time frame · 24 months

    Registry description

    The data are reported as number of participants.

Secondary outcomes(6)

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

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

    Registry description

    Progression to HRPC was defined as castrate serum testosterone less than 50 ng/dL or 1.7 nmol/L plus either; biochemical progression (three consecutive rises in prostate specific antigen (PSA) levels one week apart resulting in two 50 % increases over the nadir, with PSA greater than 2 ng/ml) or radiological progression (the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST). Data are reported as number of participants with HRPC.

  2. Median Time to Progression of HRPC

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

    Registry description

    Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. The data are reported as median (full range).

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

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

    Registry description

    Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. A Kaplan-Meier estimate of median time to progression to HRPC and 25% and 75% quartiles along with the 95% confidence interval for median were assessed.

  4. Median Survival Time

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

    Registry description

    Time to survival was estimated as time from start of leuprorelin up to study completion/discontinuation from the study or date of death. The data are reported as median months with full range.

  5. Mean Duration of Treatment-off Time in IAD Regimen

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

    Registry description

    Duration of each leuprorelin free period was calculated as (Date of first dose of leuprorelin \[cycle N+1\] minus last dose date \[cycle N\] minus 1)/30.4. If date of last dose of leuprorelin was before the date of study completion/discontinuation then the last leuprorelin free period was calculated as (Date of discontinuation/study completion minus last leuprorelin dose date)/30.4. The data are reported as mean months +/- standard deviation.

  6. Median Percentage of Time Off-treatment During 2 Years IAD Regimen

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

    Registry description

    The total duration of leuprorelin free period was calculated as the sum of all leuprorelin free periods. The data are reported as median percentage of time off-treatment with full range.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 24 months

Mean Duration of Leuprorelin Exposure

GroupValue (Months)Spread
Advanced PCa19.746.39
Primary outcomeMean· 24 months

Mean Duration of Each Leuprorelin Cycle

GroupValue (Months)Spread
Advanced PCa7.631.73
Primary outcomeMedian· 24 months

Median Number of Leuprorelin Cycles

GroupValue (Cycles)
Advanced PCa2
Secondary and other outcome results(5)
Other pre specified outcomeMean· At least 6-9 months after Baseline (enrollment)

Duration of IAD Regimen Induction Phase

GroupValue (Months)Spread
Advanced PCa7.701.25
Secondary outcomeNumber· Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit

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

GroupValue (Participants)
Advanced PCa36
Secondary outcomeMedian· Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit

Median Time to Progression of HRPC

GroupValue (Months)
Advanced PCa17.12
Secondary outcomeMedian· 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

GroupValue (Months)
Advanced PCa12.8
Secondary outcomeMedian· Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit

Median Survival Time

GroupValue (Months)
Advanced PCa18.94

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Advanced PCaParticipants with advanced PCa–13 / 28373 / 283

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Histologically confirmed advanced PCa meeting the following criteria: 1. Any Tumor, Node 1, Metastasis 0 2. Any Tumor, Node 0, Metastasis 1 \[according to Tumor Node Metastasis classification 2009\] 2. Participants planned for administration of leuprorelin 3. World Health Organization status 0-1 4. Life expectancy at least 2 years Exclusion Criteria: 1. Contraindications to administration of leuprorelin: 1. Hypersensitivity to Leuprorelin similar products of protein origin or any of the excipients in drug product composition 2. Surgical castration 2. Hormone-refractory PCa 3. Presence of another malignant tumor (except skin cancer) 4. Previous administration of hormone therapy with gonadotropin-releasing hormone agonists or antiandrogens 5. Previous administration of radiotherapy or chemotherapy course within 1 month 6. Testosterone level less than or equal to 50 ng/dl (less than or equal to 1.7 mmol/l) at time of inclusion 7. Extremely high level of PSA (greater than or equal to 1000 ng/ml) 8. Other severe diseases in stage of decompensation 9. Other contraindications, that make the participant's participation impossible (by investigator judgment) 10. Previous enrollment in the present program

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