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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753297
First received: December 17, 2012
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: Triptorelin 11.25 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Biochemical Relapse-Free Survival (BRFS) [ Time Frame: Every 3 months, up to 5 years ] [ Designated as safety issue: No ]
    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:
  • Event-Free Survival (EFS) [ Time Frame: Every 3 months, up to 5 years ] [ Designated as safety issue: No ]
    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

  • Overall Survival (OS) [ Time Frame: Every 3 months, up to 5 years ] [ Designated as safety issue: No ]
    OS defined as the time between randomisation and death from any cause

  • Time to disease-specific mortality [ Time Frame: Every 3 months, up to 5 years ] [ Designated as safety issue: No ]
    Disease-specific mortality measured as the time between randomisation and death related to prostate cancer

  • PSA Doubling Time (PSADT) [ Time Frame: Every 3 months, up to 5 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 226
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753297

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
China, Beijing
Site #156002 Withdrawn
Shijingshan, Beijing, China
China, Shanghai
Site #156003 Recruiting
Shanghai, Shanghai, China
China, Shanxi
Site #156004 Recruiting
Xi'an, Shanxi, China
China
Site #156007 Recruiting
Beijing, China
Site #156011 Active, not recruiting
Beijing, China
Site #156008 Recruiting
Chengdu, China
Site # 156010 Recruiting
Chongqing, China
Site #156005 Recruiting
Guangzhou, China
Site #156009 Recruiting
Guangzhou, China
Site #156001 Recruiting
Hangzhou, China
Site #156006 Withdrawn
Tianjin, China
Russian Federation
Site #643006 Recruiting
Barnaul, Russian Federation
Site #643004 Recruiting
Ekaterinburg, Russian Federation
Site #643001 Recruiting
Moscow, Russian Federation
Site #643002 Recruiting
Moscow, Russian Federation
Site #643005 Recruiting
Moscow, Russian Federation
Site #643003 Recruiting
Moscow, Russian Federation
Site #643007 Recruiting
Omsk, Russian Federation
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Patrick Cabri, M.D. Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01753297     History of Changes
Other Study ID Numbers: A-38-52014-194
Study First Received: December 17, 2012
Last Updated: September 30, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Triptorelin Pamoate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014