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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. (PRIORITI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01753297
Recruitment Status : Active, not recruiting
First Posted : December 20, 2012
Last Update Posted : July 25, 2019
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Triptorelin 11.25 mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2012
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Triptorelin, 11.25 mg
Triptorelin, powder and solvent for suspension (prolonged released form)
Drug: Triptorelin 11.25 mg
Triptorelin, one injection every 3 months. A total of 3 injections (at baseline, 3 and 6 months)

No Intervention: Active surveillance
Active surveillance after radical prostatectomy (RP)

Primary Outcome Measures :
  1. Biochemical Relapse-Free Survival (BRFS) [ Time Frame: Every 3 months, up to 5 years ]
    BRFS defined as period of time from randomisation to time of Biochemical Relapse (BR). BR is defined as increased prostate specific antigen (PSA) >0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later

Secondary Outcome Measures :
  1. Event-Free Survival (EFS) [ Time Frame: Every 3 months, up to 5 years ]
    EFS is defined as the period of time from randomisation to time of first diagnosed locoregional disease recurrence (positive biopsy and/or node involvement) or first metastases (bone or visceral) or death from any cause

  2. Overall Survival (OS) [ Time Frame: Every 3 months, up to 5 years ]
    OS defined as the time between randomisation and death from any cause

  3. Time to disease-specific mortality [ Time Frame: Every 3 months, up to 5 years ]
    Disease-specific mortality measured as the time between randomisation and death related to prostate cancer

  4. PSA Doubling Time (PSADT) [ Time Frame: Every 3 months, up to 5 years ]
    PSADT 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01753297

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China, Shanghai
Fudan University cancer hospital Site #156003
Shanghai, Shanghai, China
China, Shanxi
First Affiliated Hospital of the Fourth Military Medical University Site #156004
Xi'an, Shanxi, China
Chinese PLA General HospitalDepartment of UrologySite #156007
Beijing, China, 100853
Peiking University First Hospital Site #156011
Beijing, China
West China Hosspital, Sichuan UniversityDepartment of Urology Site #156008
Chengdu, China, 610041
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, China, 51006
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
Russian Federation
SIH Altaian Territorial Oncological Dispensary Site #643006
Barnaul, Russian Federation, 656052
SBHI Sverdlovskaya Regional Clinical Hospital #1 Site #643004
Ekaterinburg, Russian Federation, 620102
FSBI "Research Institute of Urology" of Ministry of health care of Russia Site #643002
Moscow, Russian Federation, 105425
State Budgetary Healthcare Institution "Moscow Clinical Scientific-Practical Center named after A. S. Loginov of Healthcare Department of Moscow" Site #643009
Moscow, Russian Federation, 111123
FSBI Russian Oncological Scientific Center named after N.N. Blokhina of RAMS, 23 Site #643001
Moscow, Russian Federation, 115478
Federal State Budgetary Health care Institution "Central clinical hospital of Russian Academy of Science (CCH RAS), in-patient unit, urological department Site #643005
Moscow, Russian Federation, 117593
FSI Moscow Research Oncological Institute named after P.A.Gertsen Site #643003
Moscow, Russian Federation, 125284
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, Russian Federation, 249036
Budgetary Health care Institution of Omsk region "Clinical oncological dispensary" Site #643007
Omsk, Russian Federation, 644013
Sponsors and Collaborators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen Identifier: NCT01753297     History of Changes
Other Study ID Numbers: A-38-52014-194
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Triptorelin Pamoate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents