Phase 4
N=226
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.
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01753297 ↗Enrolled (actual)
226
Serious AEs
3.7%
Results posted
Dec 2020
Primary outcome: Primary: Number of Subjects With BR Events — 35; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Triptorelin 11.25 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Ipsen
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With BR Events |
35; 26 | — |
| PRIMARY Median Time to BRFS |
NA; NA | 0.158 |
| PRIMARY Q1 Time to BRFS |
30.0; 39.1 | — |
| SECONDARY Median Time to Event-Free Survival (EFS) |
NA; NA | 0.639 |
| SECONDARY Q1 Time to EFS |
NA; NA | — |
| SECONDARY Median Time to Overall Survival (OS) |
NA; NA | 0.557 |
| SECONDARY Q1 Time to OS |
NA; NA | — |
| SECONDARY Time to Disease-specific Mortality |
— | — |
| SECONDARY Median Time to PSA Doubling Time (PSADT) |
NA; NA | 0.525 |
| SECONDARY Q1 Time to PSADT |
13.4; 9.1 | — |
| SECONDARY Percent Change From Baseline in PSA Levels |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Serum Testosterone Levels |
-444.60; -438.80; -429.80 | — |
| SECONDARY Change From Baseline in FACT-P Total Score |
4.75; 0.88; 1.48; 3.78; 2.76; 3.81 | — |
| SECONDARY Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS) |
2.78; 2.60; 4.49; 3.46; 4.79; 4.86 | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01753297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.