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.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-11

Study Completion Date

2019-09-09

Brief Summary

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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

Detailed Description

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This trial is a phase IV (in Russia and China) as approved indication is locally advanced or metastatic prostate cancer in both countries.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Triptorelin, 11.25 mg

Triptorelin, powder and solvent for suspension (prolonged released form)

Group Type ACTIVE_COMPARATOR

Triptorelin 11.25 mg

Intervention Type DRUG

Triptorelin, one injection every 3 months. A total of 3 injections (at baseline, 3 and 6 months)

Active surveillance

Active surveillance after radical prostatectomy (RP)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Triptorelin 11.25 mg

Triptorelin, one injection every 3 months. A total of 3 injections (at baseline, 3 and 6 months)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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A-38-52014-194

Identifier Type: -

Identifier Source: org_study_id

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.

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Triptorelin, 11.25 mg

Triptorelin 11.25 mg

Active surveillance

Interventions

Triptorelin 11.25 mg

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Ipsen

Responsible Party

Principal Investigators

Ipsen Medical Director

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

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

SBHI Sverdlovskaya Regional Clinical Hospital #1 Site #643004

Countries

Provided Documents

Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Other Identifiers

A-38-52014-194