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.

NCT01753297 | Completed Phase 4 Results

• 1 other identifier: A-38-52014-194
• Study Type: interventional
• Target: 226
• Locations: 2 countries
• Sites: 18

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Number of Subjects With BR Events

  The primary efficacy analyses of Biochemical Relapse-Free Survival (BRFS) was performed after 61 BR events were observed on the study global level. The number of subjects with BR events per treatment group is reported. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later.

  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).

• Median Time to BRFS

  BRFS was defined as the time from randomisation to time of BR. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. The time point at which the first elevated PSA measurement \>0.2 ng/mL was recorded was deemed to be the time of BR. The Kaplan-Meier method was used to obtain the estimates of median and/or first quartile (Q1) (if median was not reached) time to BRFS associated with each treatment. This outcome measure reports median time to BRFS (with Q1 time to BRFS reported in the subsequent outcome measure).

  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).

• Q1 Time to BRFS

  BRFS was defined as the time from randomisation to time of BR. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. The time point at which the first elevated PSA measurement \>0.2 ng/mL was recorded was deemed to be the time of BR. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to BRFS associated with each treatment. This outcome measure reports Q1 time to BRFS.

  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 (11)

• Median Time to Event-Free Survival (EFS)

  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).

• Q1 Time to EFS

  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).

• Median Time to Overall Survival (OS)

  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).

• Q1 Time to OS

  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).

• Time to Disease-specific Mortality

  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).

Study Arms (2)

Triptorelin, 11.25 mg

ACTIVE COMPARATOR

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

Drug: Triptorelin 11.25 mg

Active surveillance

NO INTERVENTION

Active surveillance after radical prostatectomy (RP)

Interventions

Triptorelin 11.25 mg DRUG

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

Triptorelin, 11.25 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Evidence of lymph nodes or distant metastasis
• Positive margins
• Evidence of any other malignant disease, not treated with a curative intent
• Had surgical castration

Sponsors & Collaborators

• Ipsen: lead

Study Sites (18)

Chinese PLA General HospitalDepartment of UrologySite #156007

Beijing, 100853, China

Location

Peiking University First Hospital Site #156011

Beijing, China

Location

West China Hosspital, Sichuan UniversityDepartment of Urology Site #156008

Chengdu, 610041, China

Location

The First Affiliated Hospital of the 3th Military Medical University of PLA (Southwest Hospital) Site # 156010

Chongqing, China

Location

SUN YAT-SEN Cancer Center Department of Site #156009

Guangzhou, 51006, China

Location

The third hospital affiliated to Sun Yat-sen University Site #156005

Guangzhou, China

Location

The first hospital affiliated to medical school of Zhejiang university Site #156001

Hangzhou, China

Location

Fudan University cancer hospital Site #156003

Shanghai, China

Location

First Affiliated Hospital of the Fourth Military Medical University Site #156004

Xi'an, China

Location

SIH Altaian Territorial Oncological Dispensary Site #643006

Barnaul, 656052, Russia

Location

FSBI "Research Institute of Urology" of Ministry of health care of Russia Site #643002

Moscow, 105425, Russia

Location

State Budgetary Healthcare Institution "Moscow Clinical Scientific-Practical Center named after A. S. Loginov of Healthcare Department of Moscow" Site #643009

Moscow, 111123, Russia

Location

FSBI Russian Oncological Scientific Center named after N.N. Blokhina of RAMS, 23 Site #643001

Moscow, 115478, Russia

Location

Federal State Budgetary Health care Institution "Central clinical hospital of Russian Academy of Science (CCH RAS), in-patient unit, urological department Site #643005

Moscow, 117593, Russia

Location

FSI Moscow Research Oncological Institute named after P.A.Gertsen Site #643003

Moscow, 125284, Russia

Location

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, 249036, Russia

Location

Budgetary Health care Institution of Omsk region "Clinical oncological dispensary" Site #643007

Omsk, 644013, Russia

Location

SBHI Sverdlovskaya Regional Clinical Hospital #1 Site #643004

Yekaterinburg, 620102, Russia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen Pharma SAS

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 20, 2012
• Study Start: December 11, 2012
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: December 9, 2020
• Results First Posted: December 9, 2020

Record last verified: 2020-12

Locations

CN (9); RU (9)