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

This study has been completed.
Sponsor:
Collaborator:
Almedis
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01320735
First received: February 14, 2011
Last updated: June 11, 2015
Last verified: June 2015
  Purpose

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)


Condition
Prostate Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective, Multi-Center, Observational Program to Assess Routine Use of Intermittent Adjuvant Deprivation Therapy With Lucrin Depot in Patients With Advanced Prostate Cancer in the Russian Federation

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Mean Duration of Leuprorelin Exposure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • Mean Duration of Each Leuprorelin Cycle [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • Median Number of Leuprorelin Cycles [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The Participants were on IAD regimen and the data are reported as number of cycles with full range.

  • Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The data are reported as percentage of participants.

  • Number of Participants Who Switched to IAD Regimen by Visit [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The data are reported as number of participants.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Median Time to Progression of HRPC [ Time Frame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Median Survival Time [ Time Frame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Duration of IAD Regimen Induction Phase [ Time Frame: At least 6-9 months after Baseline (enrollment) ] [ Designated as safety issue: No ]
    Time period between first injection of leuprorelin and stopping of treatment due to appropriate decrease of PSA as defined in the protocol. The data are reported as mean months +/- standard deviation.

  • Number of Participants Who Received IAD Regimen During the Study [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The data are reported as number of participants.

  • Number of Participants Who Continued to Take Leuprorelin in IAD Regimen by the End of the Study [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The data are reported as number of participants.


Enrollment: 300
Study Start Date: February 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Advanced PCa
Participants with advanced PCa

Detailed Description:

Participants started hormone treatment with Leuprorelin 3.75 mg once every 28 days, subcutaneously (SC) or intramuscularly (IM). Duration of induction therapy was at least 6 months (6-9 months) during which PSA and testosterone levels were measured every 3 months. When PSA decreased by greater than 90% from baseline (PSA less than 10 ng/ml) or became lower than 4.0 ng/ml (for 2 consecutive measurements made at least 2 weeks apart) the participants were included into intermittent hormone therapy regimen group (IAD). Participants with PSA decrease not achieved greater than 90% or less than or equal to 4.0 ng/ml were given either continuous hormone therapy (CAD) or chemotherapy.

Therapy was stopped if participants had PSA decrease greater than 90% from baseline or values less than 4.0 ng/ml after 6-9 months of continuous hormone therapy. PSA and testosterone were measured every 4 weeks. If PSA became greater than or equal to 10.0 ng/ml, hormone therapy was resumed until PSA was less than 4.0 ng/ml for 2 consecutive measurements made at least 2 weeks apart. Duration of hormonal therapy cycle was at least 3 months. Then intermittent treatment was performed according to a similar scheme. PSA and testosterone levels were determined every 12 weeks when hormone therapy was administered and every 4 weeks after it was stopped. The treatment was carried out for 2 years or until Hormone Refractory Prostate Cancer (HRPC) developed.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants with advanced PCa

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01320735

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Almedis
Investigators
Study Director: Andrey Strugovshchikov, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01320735     History of Changes
Other Study ID Numbers: P12-763
Study First Received: February 14, 2011
Results First Received: May 19, 2015
Last Updated: June 11, 2015
Health Authority: Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation

Keywords provided by AbbVie:
Lucrin Depot
intermittent adjuvant regimen
advanced prostate cancer
Leuprorelin

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Leuprolide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Fertility Agents
Fertility Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015