NCT00394511 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Swanson GP, Thompson IM, Tangem C, et al
: Phase III randomized study of adjuvant radiation therapy versus observation in patients with pathologic T3 prostate cancer (SWOG 8794). [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-1, S1, 2005.
Thompson IM, Paradelo JC, Crawford ED, Coltman CA, Blumenstein B
An opportunity to determine optimal treatment of pT3 prostate cancer: the window may be closing. Urology. 1994 Dec;44(6):804-11. Review.

Phase III Randomized Evaluation of Adjuvant Radiotherapy vs No Adjuvant Therapy Following Radical Prostatectomy and Pelvic Lymphadenectomy in Surgical Stage C Adenocarcinoma of the Prostate

Details for clinical trial NCT00394511

Clinical trial NCT00394511 - References