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The purpose of this study is to assess the benefit of immediate hormonal treatment after Radical Prostatectomy in Chinese and Russian patients with high risk prostate cancer. To reach this target, the trial will compare a group of patients treated with triptorelin at 8 weeks after the surgery and for a duration of 9 months (3 injections) versus another group (called "active surveillance group") who will be not receiving triptorelin. Both groups will be followed every 3 months to monitor any sign of disease progression during a minimum of 36 months
This trial is a phase IV (in Russia and China) as approved indication is locally advanced or metastatic prostate cancer in both countries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptorelin, 11.25 mg | Active Comparator | Triptorelin, powder and solvent for suspension (prolonged released form) |
|
| Active surveillance | No Intervention | Active surveillance after radical prostatectomy (RP) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin 11.25 mg | Drug | Triptorelin, one injection every 3 months. A total of 3 injections (at baseline, 3 and 6 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With BR Events | The primary efficacy analyses of Biochemical Relapse-Free Survival (BRFS) was performed after 61 BR events were observed on the study global level. The number of subjects with BR events per treatment group is reported. The definition of BR was increased PSA >0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
| Median Time to BRFS | BRFS was defined as the time from randomisation to time of BR. The definition of BR was increased PSA >0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. The time point at which the first elevated PSA measurement >0.2 ng/mL was recorded was deemed to be the time of BR. The Kaplan-Meier method was used to obtain the estimates of median and/or first quartile (Q1) (if median was not reached) time to BRFS associated with each treatment. This outcome measure reports median time to BRFS (with Q1 time to BRFS reported in the subsequent outcome measure). | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
| Q1 Time to BRFS | BRFS was defined as the time from randomisation to time of BR. The definition of BR was increased PSA >0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. The time point at which the first elevated PSA measurement >0.2 ng/mL was recorded was deemed to be the time of BR. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to BRFS associated with each treatment. This outcome measure reports Q1 time to BRFS. | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Event-Free Survival (EFS) | EFS was defined as the time from randomisation to time of first clinical disease progression or death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to EFS associated with each treatment. This outcome measure reports median time to EFS (with Q1 time to EFS reported in the subsequent outcome measure). |
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Inclusion Criteria:
Gleason score ≥8 on prostatectomy specimen, and/or Pre RP PSA level ≥20 ng/mL, and/or Primary tumour stage 3a (pT3a) (with any PSA level and any Gleason score)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General HospitalDepartment of UrologySite #156007 | Beijing | 100853 | China | |||
| Peiking University First Hospital Site #156011 |
Subjects had to have undergone RP no more than 8 weeks prior to randomisation, with post-RP prostate specific antigen (PSA) levels ≤0.2 nanograms/millilitre (ng/mL). The screening visit took place 6 weeks after RP (i.e. 2 weeks prior to randomisation). No other treatment for prostate cancer was permitted.
The study was conducted in male subjects with high-risk prostate cancer who had undergone radical prostatectomy (RP) in 18 sites in China and Russia between Dec 2012 and Sep 2019. The study participation for each subject was at least 36 months. The end of study was when 61 biochemical relapse (BR) events were observed on the study global level.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Surveillance | Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2013 | Sep 17, 2020 |
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| Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
| Q1 Time to EFS | EFS was defined as the time from randomisation to time of first clinical disease progression or death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to EFS associated with each treatment. This outcome measure reports Q1 time to EFS. | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
| Median Time to Overall Survival (OS) | OS was defined as the time between randomisation and death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to OS associated with each treatment. This outcome measure reports median time to OS (with Q1 time to OS reported in the subsequent outcome measure). | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
| Q1 Time to OS | OS was defined as the time between randomisation and death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to OS associated with each treatment. This outcome measure reports Q1 time to OS. | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
| Time to Disease-specific Mortality | Disease-specific mortality was measured as the time between randomisation and death related to prostate cancer. | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
| Median Time to PSA Doubling Time (PSADT) | PSADT was defined as the time from the first documented PSA increase >0.2 ng/mL to the time of the first value more than twice that of the first increased value. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) PSADT associated with each treatment. This outcome measure reports median time to PSADT (with Q1 time to PSADT reported in the subsequent outcome measure). | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
| Q1 Time to PSADT | PSADT was defined as the time from the first documented PSA increase >0.2 ng/mL to the time of the first value more than twice that of the first increased value. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) PSADT associated with each treatment. This outcome measure reports Q1 time to PSADT. | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
| Percent Change From Baseline in PSA Levels | As per inclusion criterion, all subjects in both treatment groups had PSA levels ≤0.2 ng/mL at the screening visit. Starting from Month 3, any elevated PSA concentration >0.2 ng/mL had to be confirmed by a second measurement performed 4 to 6 weeks later. No confirmation test was required after evidence of disease progression (BR and/or clinical disease progression). Subjects remained in the study until Month 36, even if they had a biochemical failure (PSA levels >0.2 ng/mL); then they could enter follow-up. The percent change from baseline was defined as the percent change from the screening visit (Day -14). Percent change from baseline in PSA levels are reported as median values at Months 3, 6, 9, 12, 24 and 36. Note: the raw baseline values for PSA levels are reported in the Baseline Characteristics section. | Screening (Day -14) and Months 3, 6, 9, 12, 24 and 36. |
| Change From Baseline in Serum Testosterone Levels | Serum testosterone levels were evaluated on blood samples taken before triptorelin injection at baseline and at 3, 6 and 9 months only in subjects in the triptorelin arm. Change from baseline in testosterone levels are reported as median values at Months 3, 6 and 9. Note: the raw baseline values for testosterone levels are reported in the Baseline Characteristics section. | Baseline (Day 1) and Months 3, 6 and 9. |
| Change From Baseline in FACT-P Total Score | Health-Related Quality of Life (HRQoL) was assessed using the FACT-P questionnaire (v4) at baseline and at 9, 24 and 36 months. The FACT-P score is composed of 27 general questions about physical, social, emotional, and functional well-being, as well as a 12-item questionnaire about prostate-specific concerns. The total FACT-P score was calculated as the sum of 39 item scores (range of 0-156); higher scores indicate a better quality of life. Change from baseline in FACT-P total score are reported as mean values at Months 9, 24 and 36. A negative change from baseline indicates decreased QoL. Note: the raw baseline values for FACT-P total score are reported in the Baseline Characteristics section. | Baseline (Day 1) and Months 9, 24 and 36. |
| Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS) | HRQoL was assessed using the SF-36 health survey (v2) at baseline and at 9, 24 and 36 months. The 36 items cover 8 health domains: PF, role-physical, BP, SF, MH, RE, VT and GH. Subscale scores were normed to the 2009 US general population (mean=50; SD=10) to give norm-based scores. Two summary measures were then calculated: PCS was derived from PF, role-physical, BP and GH; MCS was derived from SF, MH, RE and VT. The PCS and MCS norm-based scores ranged 0-100; higher scores indicate a better QoL. Change from baseline in SF-36 PCS and MSC norm-based scores are reported as mean values at Months 9, 24 and 36. A negative change from baseline indicates decreased QoL. Note: the raw baseline values for PCS and MSC norm-based scores are reported in the Baseline Characteristics section. | Baseline (Day 1) and Months 9, 24 and 36. |
| Beijing |
| China |
| West China Hosspital, Sichuan UniversityDepartment of Urology Site #156008 | Chengdu | 610041 | China |
| The First Affiliated Hospital of the 3th Military Medical University of PLA (Southwest Hospital) Site # 156010 | Chongqing | China |
| SUN YAT-SEN Cancer Center Department of Site #156009 | Guangzhou | 51006 | China |
| The third hospital affiliated to Sun Yat-sen University Site #156005 | Guangzhou | China |
| The first hospital affiliated to medical school of Zhejiang university Site #156001 | Hangzhou | China |
| Fudan University cancer hospital Site #156003 | Shanghai | China |
| First Affiliated Hospital of the Fourth Military Medical University Site #156004 | Xi'an | China |
| SIH Altaian Territorial Oncological Dispensary Site #643006 | Barnaul | 656052 | Russia |
| FSBI "Research Institute of Urology" of Ministry of health care of Russia Site #643002 | Moscow | 105425 | Russia |
| State Budgetary Healthcare Institution "Moscow Clinical Scientific-Practical Center named after A. S. Loginov of Healthcare Department of Moscow" Site #643009 | Moscow | 111123 | Russia |
| FSBI Russian Oncological Scientific Center named after N.N. Blokhina of RAMS, 23 Site #643001 | Moscow | 115478 | Russia |
| Federal State Budgetary Health care Institution "Central clinical hospital of Russian Academy of Science (CCH RAS), in-patient unit, urological department Site #643005 | Moscow | 117593 | Russia |
| FSI Moscow Research Oncological Institute named after P.A.Gertsen Site #643003 | Moscow | 125284 | Russia |
| Medical radiology research center named after A.F. Tsyba - branch of FSBI "National Medical Research Center of Radiology" of Ministry of healthcare of Russian Federation Site #643008 | Obninsk | 249036 | Russia |
| Budgetary Health care Institution of Omsk region "Clinical oncological dispensary" Site #643007 | Omsk | 644013 | Russia |
| SBHI Sverdlovskaya Regional Clinical Hospital #1 Site #643004 | Yekaterinburg | 620102 | Russia |
| Triptorelin |
Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 milligrams (mg) triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months). |
| Received Triptorelin Treatment |
|
| COMPLETED | Completed study at Month 36 or completed Follow-up |
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| NOT COMPLETED |
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|
Intention-to-Treat (ITT) population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed).
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Surveillance | Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical). |
| BG001 | Triptorelin | Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| PSA Levels | PSA levels were measured 6 weeks after RP at the screening visit (Day -14) and these were considered as the baseline values (i.e. no separate PSA measurement was taken at the baseline visit on Day 1). | Median | Inter-Quartile Range | ng/mL |
| ||||||||||||||
| Testosterone Levels | Testosterone levels were evaluated on blood samples taken before triptorelin injection at baseline (Day 1). | Only in subjects in the triptorelin arm with data available were included in the analysis. | Median | Inter-Quartile Range | nanograms per deciliter (ng/dL) |
| |||||||||||||
| Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score | The total FACT-P score is composed of 27 general questions about physical, social, emotional, and functional well-being, as well as a 12-item questionnaire about prostate-specific concerns. The total FACT-P score was calculated as the sum of 39 item scores (range of 0-156); higher scores indicate a better quality of life (QoL). | Only subjects with data available were included in the analysis. | Mean | Standard Deviation | scores on a scale |
| |||||||||||||
| 36-Item Short Form Health Survey (SF-36) Score | The SF-36 health survey contains 36 items covering 8 health domains: physical functioning (PF), role-physical, bodily pain (BP), social functioning (SF), mental health (MH), role-emotional (RE), vitality (VT) and general health (GH). Subscale scores were normed to the 2009 US general population (mean=50; standard deviation [SD]=10) to give norm-based scores. Two summary measures were then calculated: PCS was derived from PF, role-physical, BP and GH; MCS was derived from SF, MH, RE and VT. The PCS and MCS norm-based scores ranged 0-100; higher scores indicate a better QoL. | Only subjects with data available were included in the analysis | Mean | Standard Deviation | scores on a scale |
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| Gleason Score Prior to RP - Total Score in Categories | The Gleason score is an indication of prognosis based on prostate pathology. The total score ranges from 2 to 10 (ie, "1+1" to "5+5") with a higher score reflecting less-differentiated tumors with worse prognosis. The total score is a sum of two numbers which are based on the microscopic appearance of cells. The first number is the score based on the dominant, cell morphology (scored 1-5) and the second number is based on the highest grade of the non-dominant cell pattern (scored 1-5). | Only subjects with data available were included in the analysis. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With BR Events | The primary efficacy analyses of Biochemical Relapse-Free Survival (BRFS) was performed after 61 BR events were observed on the study global level. The number of subjects with BR events per treatment group is reported. The definition of BR was increased PSA >0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). | Posted | Count of Participants | Participants | No | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
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| Primary | Median Time to BRFS | BRFS was defined as the time from randomisation to time of BR. The definition of BR was increased PSA >0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. The time point at which the first elevated PSA measurement >0.2 ng/mL was recorded was deemed to be the time of BR. The Kaplan-Meier method was used to obtain the estimates of median and/or first quartile (Q1) (if median was not reached) time to BRFS associated with each treatment. This outcome measure reports median time to BRFS (with Q1 time to BRFS reported in the subsequent outcome measure). | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). | Posted | Median | 95% Confidence Interval | months | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
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| Primary | Q1 Time to BRFS | BRFS was defined as the time from randomisation to time of BR. The definition of BR was increased PSA >0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. The time point at which the first elevated PSA measurement >0.2 ng/mL was recorded was deemed to be the time of BR. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to BRFS associated with each treatment. This outcome measure reports Q1 time to BRFS. | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). | Posted | Number | 95% Confidence Interval | months | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
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| Secondary | Median Time to Event-Free Survival (EFS) | EFS was defined as the time from randomisation to time of first clinical disease progression or death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to EFS associated with each treatment. This outcome measure reports median time to EFS (with Q1 time to EFS reported in the subsequent outcome measure). | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). | Posted | Median | 95% Confidence Interval | months | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
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| Secondary | Q1 Time to EFS | EFS was defined as the time from randomisation to time of first clinical disease progression or death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to EFS associated with each treatment. This outcome measure reports Q1 time to EFS. | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). | Posted | Number | 95% Confidence Interval | months | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
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| Secondary | Median Time to Overall Survival (OS) | OS was defined as the time between randomisation and death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to OS associated with each treatment. This outcome measure reports median time to OS (with Q1 time to OS reported in the subsequent outcome measure). | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). | Posted | Median | 95% Confidence Interval | months | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
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| Secondary | Q1 Time to OS | OS was defined as the time between randomisation and death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to OS associated with each treatment. This outcome measure reports Q1 time to OS. | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). | Posted | Number | 95% Confidence Interval | months | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
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| Secondary | Time to Disease-specific Mortality | Disease-specific mortality was measured as the time between randomisation and death related to prostate cancer. | Analysis was not performed for this outcome measure as no deaths due to prostate cancer were observed during the study. | Posted | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
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| Secondary | Median Time to PSA Doubling Time (PSADT) | PSADT was defined as the time from the first documented PSA increase >0.2 ng/mL to the time of the first value more than twice that of the first increased value. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) PSADT associated with each treatment. This outcome measure reports median time to PSADT (with Q1 time to PSADT reported in the subsequent outcome measure). | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). Only subjects with increased PSA >0.2 ng/mL and with data available were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
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| Secondary | Q1 Time to PSADT | PSADT was defined as the time from the first documented PSA increase >0.2 ng/mL to the time of the first value more than twice that of the first increased value. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) PSADT associated with each treatment. This outcome measure reports Q1 time to PSADT. | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). Only subjects with increased PSA >0.2 ng/mL and with data available were included in the analysis. | Posted | Number | 95% Confidence Interval | months | Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored). |
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| Secondary | Percent Change From Baseline in PSA Levels | As per inclusion criterion, all subjects in both treatment groups had PSA levels ≤0.2 ng/mL at the screening visit. Starting from Month 3, any elevated PSA concentration >0.2 ng/mL had to be confirmed by a second measurement performed 4 to 6 weeks later. No confirmation test was required after evidence of disease progression (BR and/or clinical disease progression). Subjects remained in the study until Month 36, even if they had a biochemical failure (PSA levels >0.2 ng/mL); then they could enter follow-up. The percent change from baseline was defined as the percent change from the screening visit (Day -14). Percent change from baseline in PSA levels are reported as median values at Months 3, 6, 9, 12, 24 and 36. Note: the raw baseline values for PSA levels are reported in the Baseline Characteristics section. | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). Only subjects with data available were included in the analysis. | Posted | Median | Inter-Quartile Range | percent change | Screening (Day -14) and Months 3, 6, 9, 12, 24 and 36. |
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| Secondary | Change From Baseline in Serum Testosterone Levels | Serum testosterone levels were evaluated on blood samples taken before triptorelin injection at baseline and at 3, 6 and 9 months only in subjects in the triptorelin arm. Change from baseline in testosterone levels are reported as median values at Months 3, 6 and 9. Note: the raw baseline values for testosterone levels are reported in the Baseline Characteristics section. | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). Only subjects in the triptorelin arm with data available were included in the analysis. | Posted | Median | Inter-Quartile Range | ng/dL | Baseline (Day 1) and Months 3, 6 and 9. |
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| Secondary | Change From Baseline in FACT-P Total Score | Health-Related Quality of Life (HRQoL) was assessed using the FACT-P questionnaire (v4) at baseline and at 9, 24 and 36 months. The FACT-P score is composed of 27 general questions about physical, social, emotional, and functional well-being, as well as a 12-item questionnaire about prostate-specific concerns. The total FACT-P score was calculated as the sum of 39 item scores (range of 0-156); higher scores indicate a better quality of life. Change from baseline in FACT-P total score are reported as mean values at Months 9, 24 and 36. A negative change from baseline indicates decreased QoL. Note: the raw baseline values for FACT-P total score are reported in the Baseline Characteristics section. | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). Only subjects with data available were included in the analysis. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline (Day 1) and Months 9, 24 and 36. |
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| Secondary | Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS) | HRQoL was assessed using the SF-36 health survey (v2) at baseline and at 9, 24 and 36 months. The 36 items cover 8 health domains: PF, role-physical, BP, SF, MH, RE, VT and GH. Subscale scores were normed to the 2009 US general population (mean=50; SD=10) to give norm-based scores. Two summary measures were then calculated: PCS was derived from PF, role-physical, BP and GH; MCS was derived from SF, MH, RE and VT. The PCS and MCS norm-based scores ranged 0-100; higher scores indicate a better QoL. Change from baseline in SF-36 PCS and MSC norm-based scores are reported as mean values at Months 9, 24 and 36. A negative change from baseline indicates decreased QoL. Note: the raw baseline values for PCS and MSC norm-based scores are reported in the Baseline Characteristics section. | The ITT population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed). Only subjects with data available were included in the analysis. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline (Day 1) and Months 9, 24 and 36. |
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Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).
The safety population consisted of all randomised subjects who received at least 1 injection for subjects in the triptorelin arm or who underwent at least 1 day of active surveillance for subjects in the active surveillance arm. One subject randomised to the triptorelin arm continued in the study but refused all injections and was considered in the active surveillance arm for safety analysis. Note: All-cause mortality = death due to any cause; Other Adverse Events = non-serious events only.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Surveillance - Safety Population - Prior to Month 12 | Representing AEs reported in the active surveillance arm from Baseline (Day 1) until prior to Month 12 (Month 12 visit excluded). Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical). | 1 | 112 | 11 | 112 | 27 | 112 |
| EG001 | Triptorelin - Safety Population - Prior to Month 12 | Representing TEAEs reported in the triptorelin arm from Baseline (Day 1) until prior to Month 12 (Month 12 visit excluded); corresponding to 12 months after the first triptorelin injection. Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months). | 0 | 105 | 3 | 105 | 31 | 105 |
| EG002 | Overall Safety Population - Posterior to Month 12 | Representing AEs reported in the overall safety population from Month 12 until end of study (Month 12 up to Month 36). Since no active study drug (ie, triptorelin) was administered to any subject during this period, AEs starting from the Month 12 visit were analysed and reported overall (ie, not separately for each treatment arm). | 2 | 217 | 2 | 217 | 7 | 217 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA version 16.0 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Salivary gland calculus | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
| |
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Retroperitoneum cyst | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 16.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 16.0 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 16.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
| |
| Heat stroke | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Movement disorder | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA version 16.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA version 16.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA version 16.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA version 16.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA version 16.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA version 16.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Gingival ulceration | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Breast hyperplasia | Reproductive system and breast disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | MedDRA version 16.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen Pharma SAS | see email | clinical.trials@ipsen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 22, 2019 | Sep 17, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
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| Caucasian / White |
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| Russia |
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| Mental Component Summary (MCS) |
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| Participants |
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| Participants |
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Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months). |
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Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months). |
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