Patients With T1-4 Advanced Prostate Cancer
Conditions
Brief summary
To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)
Interventions
Sponsors
Finnish Prostate Cancer Group
Tampere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Inclusion Criteria (run-in period): T1-T4, metastatic (M1) prostate cancer T1-T4, non-metastatic (M0) prostate cancer with PSA \> 60 ng/mL T3-T4, non-metastatic (M0) prostate cancer with PSA \> 20ng/mL T1-T4, N+ prostate cancer WHO performance status 0-2 Written informed consent • Inclusion criteria to the randomised period: Patients who fulfilled all entry criteria of the run-in period Patients who completed the 24-week run-in period Patients who responded to the 24-week run-in period with a decrease of PSA to \< 10 ng/mL. If the baseline was \< 20ng/mL, at least 50% decrease from the baseline measurement is required
Exclusion criteria
(run-in period): Any previous or concurrent treatment of prostate cancer, except TURP, 5-alpha reductase inhibitor, radical prostatectomy or radiotherapy Any medication/treatment affecting sex hormone status \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time To Progression (TTP) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall and prostate cancer-specific survival, time to treatment failure, quality of life | — |
Countries
Finland
Outcome results
None listed