Prostate CancerNCT01320735
Observational Program to Assess Use of Intermittent Adjuvant Deprivation Therapy With Leuprorelin (Lucrin Depot) in Patients With Advanced Prostate Cancer (PCa) in Russia
An observational study of Prostate Cancer, run by AbbVie (prior sponsor, Abbott).
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to May 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Participants with advanced PCa
Who may be able to join
- Histologically confirmed advanced PCa meeting the following criteria:
- Any Tumor, Node 1, Metastasis 0
- Any Tumor, Node 0, Metastasis 1 [according to Tumor Node Metastasis classification 2009]
- Participants planned for administration of leuprorelin
- World Health Organization status 0-1
- Life expectancy at least 2 years
Who cannot join
- Contraindications to administration of leuprorelin:
- Hypersensitivity to Leuprorelin similar products of protein origin or any of the excipients in drug product composition
- Surgical castration
- Hormone-refractory PCa
- Presence of another malignant tumor (except skin cancer)
- Previous administration of hormone therapy with gonadotropin-releasing hormone agonists or antiandrogens
Show all 12Show fewer
- Previous administration of radiotherapy or chemotherapy course within 1 month
- Testosterone level less than or equal to 50 ng/dl (less than or equal to 1.7 mmol/l) at time of inclusion
- Extremely high level of PSA (greater than or equal to 1000 ng/ml)
- Other severe diseases in stage of decompensation
- Other contraindications, that make the participant's participation impossible (by investigator judgment)
- Previous enrollment in the present program
About this study
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
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)
Read the 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
- Keywords
- Lucrin Depot, intermittent adjuvant regimen, advanced prostate cancer, Leuprorelin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced PCa | Participants with advanced PCa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Duration of Leuprorelin Exposure
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.
Measured: 24 months
Mean Duration of Each Leuprorelin Cycle
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.
Measured: 24 months
Median Number of Leuprorelin Cycles
The Participants were on IAD regimen and the data are reported as number of cycles with full range.
Measured: 24 months
Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen
The data are reported as percentage of participants.
Measured: 24 months
Number of Participants Who Switched to IAD Regimen by Visit
The data are reported as number of participants.
Measured: 24 months
Secondary outcomes (6)
Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC)
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.
Measured: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Median Time to Progression of HRPC
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).
Measured: 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
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.
Measured: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Median Survival Time
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.
Measured: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Mean Duration of Treatment-off Time in IAD Regimen
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.
Measured: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Median Percentage of Time Off-treatment During 2 Years IAD Regimen
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.
Measured: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Almedis
- Responsible party
- Sponsor
- Investigators
- Andrey Strugovshchikov, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320735
- Sponsor's protocol ID
- P12-763
- Status last verified
- Jun 2015
- First submitted
- 14 Feb 2011
- Last updated
- 8 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01320735
- Acronym / sponsor ID
- P12-763
- Conditions
- Prostate Cancer
- Keywords
- Lucrin Depot, intermittent adjuvant regimen, advanced prostate cancer, Leuprorelin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Almedis
- Study start
- Feb 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Posted 8 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced PCa | – | –Participants with advanced PCa |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with advanced PCa
Key inclusion criteria (6 listed)
- Histologically confirmed advanced PCa meeting the following criteria:
- Participants planned for administration of leuprorelin
- World Health Organization status 0-1
- Life expectancy at least 2 years
Key exclusion criteria (12 listed)
- Contraindications to administration of leuprorelin:
- Hormone-refractory PCa
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Duration of Leuprorelin Exposure
Time frame: 24 months
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
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
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
The data are reported as percentage of participants.
Number of Participants Who Switched to IAD Regimen by Visit
Time frame: 24 months
The data are reported as number of participants.
6 secondary outcomes
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
Median Time to Progression of HRPC
Time frame: 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
Time frame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Median Survival Time
Time frame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrey Strugovshchikov, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by AbbVie (prior sponsor, Abbott).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Duration of Leuprorelin Exposure (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.