Observational Program to Assess Use of Intermittent Adjuvant Deprivation Therapy With Lucrin Depot in Patients With Advanced Prostate Cancer 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 6, 2014
Last verified: June 2014
  Purpose

300 eligible patients with advanced prostate cancer will be enrolled at 33 sites in Russia. Study medication will be administered by subcutaneous or intramuscularly injection every 28 days. Planned induction therapy at least 6-9 months. When the prostate specific antigen decreases by > 90% from baseline or becomes lower than 4.0ng/ml the patients are included into intermittent hormone therapy group. Patients with prostate specific antigen decrease not achieved > 90% from baseline or down to values of 4.0 ng/ml or lower are withdrawn from the trial: they will receive standard-of-care.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective, Multi-Center, Post-marketing, Observational Study 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:
  • Duration of induction stage [ Time Frame: Induction therapy is planned at least 6-9 months after visit 1 ] [ Designated as safety issue: No ]
    Time period between first injection of Lucrin Depot and stopping of treatment due to appropriate decrease of prostate specific antigen

  • Number of patients received Lucrin Depot in intermittent adjuvant regimen [ Time Frame: 2 years of observation ] [ Designated as safety issue: No ]
  • Number of patients continuing taking Lucrin Depot in intermittent adjuvant regimen by the end of program [ Time Frame: 2 years of observation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to onset of hormone-refractory prostate cancer in intermittent adjuvant deprivation subjects [ Time Frame: For a duration of 2 years of observation and 30 days of follow-up period ] [ Designated as safety issue: No ]
    To describe the rates of hormone refractory stage in patients with advanced prostate cancer receiving intermittent hormone monotherapy with Lucrin Depot in Russian Federation during 2 years

  • Duration of treatment-off period in intermittent adjuvant deprivation regimen [ Time Frame: For a duration of 2 years of observation ] [ Designated as safety issue: No ]
    To evaluate median percentage of time off-treatment during 2 years

  • Patients' age [ Time Frame: Demographic information will be collected during first visit at the site ] [ Designated as safety issue: No ]
  • Patients' race [ Time Frame: Demographic information will be collected during first visit at the site ] [ Designated as safety issue: No ]

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 prostate cancer
Planned for administration of Lucrin Depot patients with advanced prostate cancer

Detailed Description:

300 patients with advanced prostate cancer will be enrolled at 33 sites in Russia. The eligible patients will start hormone treatment with Lucrin depot 3.75 mg once every 28 days, subcutaneously or intramuscularly. Duration of induction therapy planned at least 6 months (6-9 months). After prostate specific antigen and testosterone levels are measured every 3 months. When prostate specific antigen decreases by > 90% from baseline (prostate specific antigen should be < 10 ng/ml ) or becomes lower than 4.0ng/ml (for 2 consecutive measurements made at least 2 weeks apart) the patients are included into intermittent hormone therapy group. Patients with prostate specific antigen decrease not achieved > 90% from baseline or down to values of 4.0 ng/ml or lower are withdrawn from the trial: they will receive standard-of-care.

In patients having prostate specific antigen decrease > 90% from baseline (prostate specific antigen should be < 10 ng/ml) or values less than 4.0 ng/ml after 6-9 months of continuous hormone therapy, the therapy is stopped. The patients are followed-up and their prostate specific antigen and testosterone being measured every 4 weeks. If prostate specific antigen becomes ≥ 10.0 ng/ml, hormone therapy is resumed until prostate specific antigen is < 4.0 ng/ml for 2 consecutive measurements made at least 2 weeks apart. Duration of hormonal therapy cycle should be at least 3 months. Then intermitting treatment is performed according to similar scheme. Prostate specific antigen and testosterone are determined each 12 weeks when hormone therapy is administered and each 4 weeks after it has been stopped. The treatment is carried out for 2 years or until hormone refractory prostate cancer develops.

The duration of observation of therapy is carried out for 2 years or until hormone refractory prostate cancer develops.

Treatment patterns in use of Lucrin Depot in intermittent adjuvant regimen, the rates of hormone refractory stage in patients with advanced prostate cancer receiving intermittent hormone monotherapy will be described.

  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

Primary care clinic

Criteria

Inclusion Criteria:

  • Histologically confirmed advanced prostate cancer meeting the following criteria:

    • Any Tumor, Node 1, Metastasis 0
    • Any Tumor, Node 0, Metastasis 1 [according to Tumor Node Metastasis classification 2009]
  • Patients planned for administration of Lucrin Depot
  • World Health Organization status 0-1
  • Life expectancy at least 2 years

Exclusion Criteria:

  • Contraindications to administration of Lucrin Depot (Leuprorelin):

    • Hypersensitivity to Leuprorelin similar products of protein origin or any of the excipients in drug product composition
    • Surgical castration
  • Hormone-refractory prostate cancer
  • 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
  • Testosterone level ≤ 50 ng/dl (≤ 1,7 mmol/l) at time of inclusion
  • Extremely high level of prostate specific antigen (≥ 1000 ng/ml)
  • Other severe diseases in stage of decompensation
  • Other contraindications, that make the patients participation impossible (by investigator judgment)
  • Previous enrollment in the present program
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Russian Federation
Site Reference ID/Investigator# 49121
Chelabinsk, Russian Federation, 454087
Site Reference ID/Investigator# 49128
Ekaterinburg, Russian Federation, 620102
Site Reference ID/Investigator# 49123
Izhevsk, Russian Federation, 426009
Site Reference ID/Investigator# 49133
Krasnoyarsk, Russian Federation, 660133
Site Reference ID/Investigator# 49108
Moscow, Russian Federation, 123098
Site Reference ID/Investigator# 48905
Moscow, Russian Federation, 105425
Site Reference ID/Investigator# 49107
Moscow, Russian Federation, 105077
Site Reference ID/Investigator# 49103
Moscow, Russian Federation, 121356
Site Reference ID/Investigator# 49105
Moscow, Russian Federation, 117997
Site Reference ID/Investigator# 49111
Penza, Russian Federation, 440028
Site Reference ID/Investigator# 49118
Rostov-on-Don, Russian Federation, 344017
Site Reference ID/Investigator# 49119
Samara, Russian Federation, 443031
Site Reference ID/Investigator# 49126
Saratov, Russian Federation, 410053
Site Reference ID/Investigator# 49125
Saratov, Russian Federation, 410054
Site Reference ID/Investigator# 49109
St. Petersburg, Russian Federation, 197758
Site Reference ID/Investigator# 49116
St. Petersburg, Russian Federation, 198255
Site Reference ID/Investigator# 49113
St. Petersburg, Russian Federation, 198255
Site Reference ID/Investigator# 49112
St. Petersburg, Russian Federation, 194291
Site Reference ID/Investigator# 49132
Stavropol, Russian Federation, 355047
Site Reference ID/Investigator# 49129
Tumen, Russian Federation, 625041
Site Reference ID/Investigator# 49131
Tumen, Russian Federation, 625041
Site Reference ID/Investigator# 49120
Ufa, Russian Federation, 4500548
Site Reference ID/Investigator# 49115
Voronezh, Russian Federation, 394066
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
Last Updated: June 6, 2014
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

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 October 23, 2014