Back to resultsA Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients. (PRIORITI)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Triptorelin 11.25 mg
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Histopathologically confirmed adenocarcinoma of the prostate
- Radical Prostatectomy with curative intent performed no more than 8 weeks before randomisation
- High risk criteria of disease progression, defined as follows:
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)
- Post-RP PSA levels ≤0.2 ng/mL at 6 weeks
Exclusion Criteria:
- Evidence of lymph nodes or distant metastasis
- Positive margins
- Evidence of any other malignant disease, not treated with a curative intent
- Had surgical castration
Sites / Locations
- Chinese PLA General HospitalDepartment of UrologySite #156007
- Peiking University First Hospital Site #156011
- West China Hosspital, Sichuan UniversityDepartment of Urology Site #156008
- The First Affiliated Hospital of the 3th Military Medical University of PLA (Southwest Hospital) Site # 156010
- SUN YAT-SEN Cancer Center Department of Site #156009
- The third hospital affiliated to Sun Yat-sen University Site #156005
- The first hospital affiliated to medical school of Zhejiang university Site #156001
- Fudan University cancer hospital Site #156003
- First Affiliated Hospital of the Fourth Military Medical University Site #156004
- SIH Altaian Territorial Oncological Dispensary Site #643006
- SBHI Sverdlovskaya Regional Clinical Hospital #1 Site #643004
- FSBI "Research Institute of Urology" of Ministry of health care of Russia Site #643002
- State Budgetary Healthcare Institution "Moscow Clinical Scientific-Practical Center named after A. S. Loginov of Healthcare Department of Moscow" Site #643009
- FSBI Russian Oncological Scientific Center named after N.N. Blokhina of RAMS, 23 Site #643001
- Federal State Budgetary Health care Institution "Central clinical hospital of Russian Academy of Science (CCH RAS), in-patient unit, urological department Site #643005
- FSI Moscow Research Oncological Institute named after P.A.Gertsen Site #643003
- 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
- Budgetary Health care Institution of Omsk region "Clinical oncological dispensary" Site #643007
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Triptorelin, 11.25 mg
Active surveillance
Arm Description
Triptorelin, powder and solvent for suspension (prolonged released form)
Active surveillance after radical prostatectomy (RP)
Outcomes
Primary Outcome Measures
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.
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).
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.
Secondary Outcome Measures
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).
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.
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).
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.
Time to Disease-specific Mortality
Disease-specific mortality was measured as the time between randomisation and death related to prostate cancer.
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).
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01753297
Brief Title
A Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients.
Acronym
PRIORITI
Official Title
A Multicentric, Multinational (China and Russia), Randomised, Open, Controlled Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 11, 2012 (Actual)
Primary Completion Date
September 9, 2019 (Actual)
Study Completion Date
September 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
This trial is a phase IV (in Russia and China) as approved indication is locally advanced or metastatic prostate cancer in both countries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triptorelin, 11.25 mg
Arm Type
Active Comparator
Arm Description
Triptorelin, powder and solvent for suspension (prolonged released form)
Arm Title
Active surveillance
Arm Type
No Intervention
Arm Description
Active surveillance after radical prostatectomy (RP)
Intervention Type
Drug
Intervention Name(s)
Triptorelin 11.25 mg
Intervention Description
Triptorelin, one injection every 3 months. A total of 3 injections (at baseline, 3 and 6 months)
Primary Outcome Measure Information:
Title
Number of Subjects With BR Events
Description
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.
Time Frame
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).
Title
Median Time to BRFS
Description
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).
Time Frame
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).
Title
Q1 Time to BRFS
Description
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.
Time Frame
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).
Secondary Outcome Measure Information:
Title
Median Time to Event-Free Survival (EFS)
Description
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).
Time Frame
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).
Title
Q1 Time to EFS
Description
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.
Time Frame
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).
Title
Median Time to Overall Survival (OS)
Description
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).
Time Frame
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).
Title
Q1 Time to OS
Description
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.
Time Frame
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).
Title
Time to Disease-specific Mortality
Description
Disease-specific mortality was measured as the time between randomisation and death related to prostate cancer.
Time Frame
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).
Title
Median Time to PSA Doubling Time (PSADT)
Description
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).
Time Frame
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).
Title
Q1 Time to PSADT
Description
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.
Time Frame
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).
Title
Percent Change From Baseline in PSA Levels
Description
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.
Time Frame
Screening (Day -14) and Months 3, 6, 9, 12, 24 and 36.
Title
Change From Baseline in Serum Testosterone Levels
Description
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.
Time Frame
Baseline (Day 1) and Months 3, 6 and 9.
Title
Change From Baseline in FACT-P Total Score
Description
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.
Time Frame
Baseline (Day 1) and Months 9, 24 and 36.
Title
Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS)
Description
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.
Time Frame
Baseline (Day 1) and Months 9, 24 and 36.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histopathologically confirmed adenocarcinoma of the prostate
Radical Prostatectomy with curative intent performed no more than 8 weeks before randomisation
High risk criteria of disease progression, defined as follows:
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)
Post-RP PSA levels ≤0.2 ng/mL at 6 weeks
Exclusion Criteria:
Evidence of lymph nodes or distant metastasis
Positive margins
Evidence of any other malignant disease, not treated with a curative intent
Had surgical castration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Chinese PLA General HospitalDepartment of UrologySite #156007
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Peiking University First Hospital Site #156011
City
Beijing
Country
China
Facility Name
West China Hosspital, Sichuan UniversityDepartment of Urology Site #156008
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
The First Affiliated Hospital of the 3th Military Medical University of PLA (Southwest Hospital) Site # 156010
City
Chongqing
Country
China
Facility Name
SUN YAT-SEN Cancer Center Department of Site #156009
City
Guangzhou
ZIP/Postal Code
51006
Country
China
Facility Name
The third hospital affiliated to Sun Yat-sen University Site #156005
City
Guangzhou
Country
China
Facility Name
The first hospital affiliated to medical school of Zhejiang university Site #156001
City
Hangzhou
Country
China
Facility Name
Fudan University cancer hospital Site #156003
City
Shanghai
Country
China
Facility Name
First Affiliated Hospital of the Fourth Military Medical University Site #156004
City
Xi'an
Country
China
Facility Name
SIH Altaian Territorial Oncological Dispensary Site #643006
City
Barnaul
ZIP/Postal Code
656052
Country
Russian Federation
Facility Name
SBHI Sverdlovskaya Regional Clinical Hospital #1 Site #643004
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
FSBI "Research Institute of Urology" of Ministry of health care of Russia Site #643002
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Moscow Clinical Scientific-Practical Center named after A. S. Loginov of Healthcare Department of Moscow" Site #643009
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
FSBI Russian Oncological Scientific Center named after N.N. Blokhina of RAMS, 23 Site #643001
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Federal State Budgetary Health care Institution "Central clinical hospital of Russian Academy of Science (CCH RAS), in-patient unit, urological department Site #643005
City
Moscow
ZIP/Postal Code
117593
Country
Russian Federation
Facility Name
FSI Moscow Research Oncological Institute named after P.A.Gertsen Site #643003
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
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
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Budgetary Health care Institution of Omsk region "Clinical oncological dispensary" Site #643007
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
A Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients.
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