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. - Full Text View

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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Triptorelin pamoate

U.S. FDA Resources

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:	April 2013
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

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	Not yet recruiting
Shijingshan, Beijing, China
Contact: Li Ning-chen
China
Site #156005	Not yet recruiting
Guangzhou, China
Contact: Gao Xin
Site #156001	Not yet recruiting
Hangzhou, China
Contact: Xie Li-Ping
Site #156003	Not yet recruiting
Shanghai, China
Contact: Ye Ding-Wei
Site #156004	Not yet recruiting
Shanghai, China
Contact: Xia Shu-jie
Site #156006	Not yet recruiting
Tianjin, China
Contact: Xu Yong

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:	April 2, 2013
Health Authority:	Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin
Luteolytic Agents

Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 18, 2013

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)