Randomized Adjuvant Phase III Trial of Six Cycles of Docetaxel+Hormonal Treatment Versus Hormonal Treatment in Patients With Intermediate or High-risk Prostate Cancer Treated With Radical Radiotherapy
Primary endpoint:
- PSA progression rate, ASTRO guidelines.
Secondary endpoints:
- PSA doubling time after progression
- Quality of Life (QoL)
- Safety
- Metastases free survival
- Overall survival
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA progression rate
From randomization to progression
No
Pirkko-Liisa i Kellokumpu-Lehtinen, Prof
Principal Investigator
Tampere University Hospital
Finland: Finnish Medicines Agency
SPCG-13
NCT00653848
May 2007
December 2017
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