Clinical trial NCT01320735: Observational Program to Assess Use of Intermittent Adjuvant Deprivation Therapy With Leuprorelin (Lucrin Depot) in Patients With Advanced Prostate Cancer (PCa) in Russia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Lucrin Depot
intermittent adjuvant regimen
advanced prostate cancer
Leuprorelin
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Almedis
First posted: 2011-03-22
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with advanced PCa

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.

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

Primary outcomes:
measure: Mean Duration of Leuprorelin Exposure
timeFrame: 24 months
measure: Mean Duration of Each Leuprorelin Cycle
timeFrame: 24 months
measure: Median Number of Leuprorelin Cycles
timeFrame: 24 months
measure: Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen
timeFrame: 24 months
measure: Number of Participants Who Switched to IAD Regimen by Visit
timeFrame: 24 months
Secondary outcomes:
measure: Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC)
timeFrame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
measure: Median Time to Progression of HRPC
timeFrame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
measure: Median Time to Progression of HRPC in Participants Not Started on IAD Regimen
timeFrame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
measure: Median Survival Time
timeFrame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
measure: Mean Duration of Treatment-off Time in IAD Regimen
timeFrame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
measure: Median Percentage of Time Off-treatment During 2 Years IAD Regimen
timeFrame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Other outcomes:
measure: Duration of IAD Regimen Induction Phase
timeFrame: At least 6-9 months after Baseline (enrollment)
measure: Number of Participants Who Received IAD Regimen During the Study
timeFrame: 24 months
measure: Number of Participants Who Continued to Take Leuprorelin in IAD Regimen by the End of the Study
timeFrame: 24 months
Locations:
Study officials:
affiliation: AbbVie
name: Andrey Strugovshchikov, MD
role: STUDY_DIRECTOR
References: