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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)

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ClinicalTrials.gov Identifier: NCT01753297
Recruitment Status : Completed
First Posted : December 20, 2012
Results First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

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)
Actual 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
Actual Study Start Date : December 11, 2012
Actual Primary Completion Date : September 9, 2019
Actual Study Completion Date : September 9, 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. Number of Subjects With BR Events [ Time Frame: 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). ]
    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.

  2. Median Time to BRFS [ Time Frame: 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). ]
    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).

  3. Q1 Time to BRFS [ Time Frame: 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). ]
    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.


Secondary Outcome Measures :
  1. Median Time to Event-Free Survival (EFS) [ Time Frame: 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). ]
    EFS was defined as the time from randomisation to time of first clinical disease progression or death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to EFS associated with each treatment. This outcome measure reports median time to EFS (with Q1 time to EFS reported in the subsequent outcome measure).

  2. Q1 Time to EFS [ Time Frame: 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). ]
    EFS was defined as the time from randomisation to time of first clinical disease progression or death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to EFS associated with each treatment. This outcome measure reports Q1 time to EFS.

  3. Median Time to Overall Survival (OS) [ Time Frame: 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). ]
    OS was defined as the time between randomisation and death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to OS associated with each treatment. This outcome measure reports median time to OS (with Q1 time to OS reported in the subsequent outcome measure).

  4. Q1 Time to OS [ Time Frame: 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). ]
    OS was defined as the time between randomisation and death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to OS associated with each treatment. This outcome measure reports Q1 time to OS.

  5. Time to Disease-specific Mortality [ Time Frame: 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). ]
    Disease-specific mortality was measured as the time between randomisation and death related to prostate cancer.

  6. Median Time to PSA Doubling Time (PSADT) [ Time Frame: 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). ]
    PSADT was 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. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) PSADT associated with each treatment. This outcome measure reports median time to PSADT (with Q1 time to PSADT reported in the subsequent outcome measure).

  7. Q1 Time to PSADT [ Time Frame: 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). ]
    PSADT was 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. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) PSADT associated with each treatment. This outcome measure reports Q1 time to PSADT.

  8. Percent Change From Baseline in PSA Levels [ Time Frame: Screening (Day -14) and Months 3, 6, 9, 12, 24 and 36. ]
    As per inclusion criterion, all subjects in both treatment groups had PSA levels ≤0.2 ng/mL at the screening visit. Starting from Month 3, any elevated PSA concentration >0.2 ng/mL had to be confirmed by a second measurement performed 4 to 6 weeks later. No confirmation test was required after evidence of disease progression (BR and/or clinical disease progression). Subjects remained in the study until Month 36, even if they had a biochemical failure (PSA levels >0.2 ng/mL); then they could enter follow-up. The percent change from baseline was defined as the percent change from the screening visit (Day -14). Percent change from baseline in PSA levels are reported as median values at Months 3, 6, 9, 12, 24 and 36. Note: the raw baseline values for PSA levels are reported in the Baseline Characteristics section.

  9. Change From Baseline in Serum Testosterone Levels [ Time Frame: Baseline (Day 1) and Months 3, 6 and 9. ]
    Serum testosterone levels were evaluated on blood samples taken before triptorelin injection at baseline and at 3, 6 and 9 months only in subjects in the triptorelin arm. Change from baseline in testosterone levels are reported as median values at Months 3, 6 and 9. Note: the raw baseline values for testosterone levels are reported in the Baseline Characteristics section.

  10. Change From Baseline in FACT-P Total Score [ Time Frame: Baseline (Day 1) and Months 9, 24 and 36. ]
    Health-Related Quality of Life (HRQoL) was assessed using the FACT-P questionnaire (v4) at baseline and at 9, 24 and 36 months. The FACT-P score is composed of 27 general questions about physical, social, emotional, and functional well-being, as well as a 12-item questionnaire about prostate-specific concerns. The total FACT-P score was calculated as the sum of 39 item scores (range of 0-156); higher scores indicate a better quality of life. Change from baseline in FACT-P total score are reported as mean values at Months 9, 24 and 36. A negative change from baseline indicates decreased QoL. Note: the raw baseline values for FACT-P total score are reported in the Baseline Characteristics section.

  11. Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS) [ Time Frame: Baseline (Day 1) and Months 9, 24 and 36. ]
    HRQoL was assessed using the SF-36 health survey (v2) at baseline and at 9, 24 and 36 months. The 36 items cover 8 health domains: PF, role-physical, BP, SF, MH, RE, VT and GH. Subscale scores were normed to the 2009 US general population (mean=50; SD=10) to give norm-based scores. Two summary measures were then calculated: PCS was derived from PF, role-physical, BP and GH; MCS was derived from SF, MH, RE and VT. The PCS and MCS norm-based scores ranged 0-100; higher scores indicate a better QoL. Change from baseline in SF-36 PCS and MSC norm-based scores are reported as mean values at Months 9, 24 and 36. A negative change from baseline indicates decreased QoL. Note: the raw baseline values for PCS and MSC norm-based scores are reported in the Baseline Characteristics section.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

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 ClinicalTrials.gov identifier (NCT number): NCT01753297


Locations
Show Show 18 study locations
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
  Study Documents (Full-Text)

Documents provided by Ipsen:
Study Protocol  [PDF] June 7, 2013
Statistical Analysis Plan  [PDF] July 22, 2019

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01753297    
Other Study ID Numbers: A-38-52014-194
First Posted: December 20, 2012    Key Record Dates
Results First Posted: December 9, 2020
Last Update Posted: December 9, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents