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PCS III: Androgen Blockade + RT in Prostate Cancer
NCT00223145Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Dec 2000
- Primary completion
- Dec 2026
- Countries
- 1
- Modality
- Peptides, Small Molecules
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 3, randomised, open-label trial of bicalutamide and goserelin in prostate cancer (PCa) (3 arms). Primary endpoint: Interval before biochemical failure at 10 years. Started Dec 2000; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
ADT + RT 70 Gy
6 months Androgen Blockade + 70 Gy RT
ADT + RT 76 Gy
6 months Androgen Blockade + 76 Gy RT
RT 76 Gy
Radiotherapy 76 Gy alone
03
Who it enrols
Patients with intermediate-risk T1-T2 prostate adenocarcinoma (Gleason <= 6 with PSA 10-20 or Gleason 7 with PSA <= 20), no regional or metastatic disease, and good performance status.
04
Endpoints
Primary
Interval before biochemical failure
Secondary
Toxicity of irradiation
Overall Survival
05
Results
Primary endpoints met
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