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.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ipsen
This trial is a phase IV (in Russia and China) as approved indication is locally advanced or metastatic prostate cancer in both countries.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | 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.
