NCT01420965 - 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)

Crawford ED, Eisenberger MA, McLeod DG, Spaulding JT, Benson R, Dorr FA, Blumenstein BA, Davis MA, Goodman PJ
A controlled trial of leuprolide with and without flutamide in prostatic carcinoma. N Engl J Med. 1989 Aug 17;321(7):419-24. Erratum in: N Engl J Med 1989 Nov 16;321(20):1420.
Gittes RF
Carcinoma of the prostate. N Engl J Med. 1991 Jan 24;324(4):236-45. Review.
Jemal A, Center MM, DeSantis C, Ward EM
Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev. 2010 Aug;19(8):1893-907. doi: 10.1158/1055-9965.EPI-10-0437. Epub 2010 Jul 20. Review.

A Pilot Study to Test the Feasibility and Immunologic Impact of Sipuleucel-T (Provenge) Administered With or Without Anti-PD-1 mAb (CT-011) and Low Dose Cyclophosphamide in Men With Advanced Castrate-Resistant Prostate Cancer

Details for clinical trial NCT01420965

Clinical trial NCT01420965 - References