Clinical trial NCT01753297: 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.
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 226
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Subjects With BR Events
timeFrame: 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: Median Time to BRFS
timeFrame: 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: Q1 Time to BRFS
timeFrame: 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 outcomes:
measure: Median Time to Event-Free Survival (EFS)
timeFrame: 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: Q1 Time to EFS
timeFrame: 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: Median Time to Overall Survival (OS)
timeFrame: 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: Q1 Time to OS
timeFrame: 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: Time to Disease-specific Mortality
timeFrame: 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: Median Time to PSA Doubling Time (PSADT)
timeFrame: 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: Q1 Time to PSADT
timeFrame: 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: Percent Change From Baseline in PSA Levels
timeFrame: Screening (Day -14) and Months 3, 6, 9, 12, 24 and 36.
measure: Change From Baseline in Serum Testosterone Levels
timeFrame: Baseline (Day 1) and Months 3, 6 and 9.
measure: Change From Baseline in FACT-P Total Score
timeFrame: Baseline (Day 1) and Months 9, 24 and 36.
measure: Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS)
timeFrame: Baseline (Day 1) and Months 9, 24 and 36.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General HospitalDepartment of UrologySite #156007
city: Beijing
country: China
facility: Peiking University First Hospital Site #156011
city: Chengdu
country: China
facility: West China Hosspital, Sichuan UniversityDepartment of Urology Site #156008
city: Chongqing
country: China
facility: The First Affiliated Hospital of the 3th Military Medical University of PLA (Southwest Hospital) Site # 156010
city: Guangzhou
country: China
facility: SUN YAT-SEN Cancer Center Department of Site #156009
city: Guangzhou
country: China
facility: The third hospital affiliated to Sun Yat-sen University Site #156005
city: Hangzhou
country: China
facility: The first hospital affiliated to medical school of Zhejiang university Site #156001
city: Shanghai
country: China
facility: Fudan University cancer hospital Site #156003
city: Xi'an
country: China
facility: First Affiliated Hospital of the Fourth Military Medical University Site #156004
city: Barnaul
country: Russian Federation
facility: SIH Altaian Territorial Oncological Dispensary Site #643006
city: Ekaterinburg
country: Russian Federation
facility: SBHI Sverdlovskaya Regional Clinical Hospital #1 Site #643004
city: Moscow
country: Russian Federation
facility: FSBI "Research Institute of Urology" of Ministry of health care of Russia Site #643002
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution "Moscow Clinical Scientific-Practical Center named after A. S. Loginov of Healthcare Department of Moscow" Site #643009
city: Moscow
country: Russian Federation
facility: FSBI Russian Oncological Scientific Center named after N.N. Blokhina of RAMS, 23 Site #643001
city: Moscow
country: Russian Federation
facility: 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
country: Russian Federation
facility: FSI Moscow Research Oncological Institute named after P.A.Gertsen Site #643003
city: Obninsk
country: Russian Federation
facility: 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: Omsk
country: Russian Federation
facility: Budgetary Health care Institution of Omsk region "Clinical oncological dispensary" Site #643007
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: