Bolla M, Van Poppel H, Van Cangh P, et al : Does post-operative radiotherapy (P-RXT) after radical prostatectomy (Px) improve progression-free survival (PFS) in pT3N0 prostate cancer (PC)? (EORTC 22911). [Abstract] J Clin Oncol 22 (Suppl 14): A-4504, 383,
Bolla M, Van Poppel H, Van Cangh P, et al : Post-operative radiotherapy (P-RXT) after radical prostatectomy (Px) improves progression-free survival (PFS) in pT3NO prostate cancer (PC) (EORTC 22911). [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1):
Davis JB, Reiner B, Dusserre A, Giraud JY, Bolla M; EORTC Quality assurance of the EORTC trial 22911. A phase III study of post-operative external radiotherapy in pathological stage T3N0 prostatic carcinoma: the dummy run. Radiother Oncol. 2002 Jul;64(1)
Ganswindt U, Stenzl A, Bamberg M, Belka C Adjuvant radiotherapy for patients with locally advanced prostate cancer--a new standard? Eur Urol. 2008 Sep;54(3):528-42. doi: 10.1016/j.eururo.2008.06.059. Epub 2008 Jun 23. Review.
Gomella LG Re: identification of patients with prostate cancer who benefit from immediate postoperative radiotherapy: EORTC 22911. Eur Urol. 2008 Apr;53(4):855-6.
Graefen M Words of wisdom. Re: Identification of patients with prostate cancer who benefit from immediate postoperative radiotherapy: EORTC 22911. Eur Urol. 2008 Mar;53(3):664-5.
Tombal B, Scaillet P, Opsomer R, et al : Immediate external beam radiation therapy (EBRT) after radical prostatectomy (PCa): long-term influence on QOL, urinary and rectal symptoms. [Abstract] American Urological Association: Annual Meeting, May 20-25, 20
van der Kwast TH, Bolla M, van Poppel H, et al : Gleason Score and margin status are the strongest predictors for benefit of radiotherapy after radical prostatectomy. [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
