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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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.

Short name PRIORITI

NCTNCT01753297 (opens ClinicalTrials.gov in a new tab)Other idA-38-52014-194
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
226 participants (actual)
Sponsor
Ipsen · Industry
Design
Randomized · Open label (no masking)
Countries
2 countries

China, Russia

Start
11 Dec 2012
Primary completion
9 Sept 2019
Completion
9 Sept 2019
First posted
20 Dec 2012 (estimated)
Last update posted
9 Dec 2020
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122014201620182020
  1. Ph 4

    PRIORITI

    NCT01753297

    11 Dec 2012 to 9 Sept 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Triptorelin 11.25 mgDrug

Arms2

  • Active comparator

    Triptorelin, 11.25 mg

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

  • No intervention

    Active surveillance

    Active surveillance after radical prostatectomy (RP)

Primary outcomes3

Outcomes the sponsor listed as primary.

  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).

    Registry description

    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).

    Registry description

    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).

    Registry description

    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 outcomes(11)

  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).

    Registry description

    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).

    Registry description

    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).

    Registry description

    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).

    Registry description

    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).

    Registry description

    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).

    Registry description

    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).

    Registry description

    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.

    Registry description

    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.

    Registry description

    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.

    Registry description

    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.

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 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).

Number of Subjects With BR Events

GroupValue (Participants)
Active Surveillance35
Triptorelin26
Primary outcomeMedian· 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

GroupValue (months)
Active SurveillanceNA
TriptorelinNA
Primary outcomeNumber· 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

GroupValue (months)
Active Surveillance30.0
Triptorelin39.1
Secondary and other outcome results(5)
Secondary outcomeMedian· 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 Event-Free Survival (EFS)

GroupValue (months)
Active SurveillanceNA
TriptorelinNA
Secondary outcomeNumber· 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

GroupValue (months)
Active SurveillanceNA
TriptorelinNA
Secondary outcomeMedian· 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)

GroupValue (months)
Active SurveillanceNA
TriptorelinNA
Secondary outcomeNumber· 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

GroupValue (months)
Active SurveillanceNA
TriptorelinNA
Secondary outcome· 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

GroupValue
Active Surveillancenot posted
Triptorelinnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Active Surveillance - Safety Population - Prior to Month 12Representing AEs reported in the active surveillance arm from Baseline (Day 1) until prior to Month 12 (Month 12 visit excluded). Subjects were treated according to each study centre's standard of care. No adjuvant treatment with any method (hormonal treatment and/or surgical castration and/or radiation therapy) was initiated prior to evidence of disease progression (clinical or biochemical).1 / 11211 / 11227 / 112
Triptorelin - Safety Population - Prior to Month 12Representing TEAEs reported in the triptorelin arm from Baseline (Day 1) until prior to Month 12 (Month 12 visit excluded); corresponding to 12 months after the first triptorelin injection. Subjects were treated with triptorelin as a hormonal adjuvant to RP and received intramuscular injections of 11.25 mg triptorelin every 3 months for a total of 3 injections (at baseline, 3 months and 6 months).0 / 1053 / 10531 / 105
Overall Safety Population - Posterior to Month 12Representing AEs reported in the overall safety population from Month 12 until end of study (Month 12 up to Month 36). Since no active study drug (ie, triptorelin) was administered to any subject during this period, AEs starting from the Month 12 visit were analysed and reported overall (ie, not separately for each treatment arm).2 / 2172 / 2177 / 217

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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