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

NCT ID: NCT01320735

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-05-31

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)

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.

Conditions

Prostate Cancer

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Advanced PCa

Participants with advanced PCa

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Almedis

INDUSTRY

Sponsor Role: collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrey Strugovshchikov, MD

Role: STUDY_DIRECTOR

AbbVie

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

P12-763

Identifier Type: -

Identifier Source: org_study_id