Investigation of Early Hormonotherapy Efficacy of Prostate Cancer

Kaunas University of Medicine

Status: Unknown

Conditions: Prostate Cancer

Treatments: Drug: Triptorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT00375687

KMU-Urol1

Details and patient eligibility

About

The purpose of this study is to determine whether early hormonotherapy is effective in the treatment of high risk prostate cancer patients after radical prostatectomy.

Full description

The primary purpose of this study is to evaluate the hypothesis, that early administration of adjuvant hormonotherapy (triptorelin) can prolong survival data for high risk patients. Control group (randomised study) will be treated with hormonotherapy, when PSA recidive appear (on demand treatment). Secondary purposes will be to compare PSA dinamics and quality of life data in the groups.

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• preoperative PSA>20ng/ml
• postoperative PSA >0.2 ng/ml
• Gleason > 7
• pT3b
• signated infomed consent

Exclusion criteria

• neoadjuvant hormonaltherapy before RP
• R1 RP
• N+ RP
• unstable cncomitant conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)