Can dutasteride delay or prevent the progression of prostate cancer in patients with biochemical failure after radical therapy? Rationale and design of the Avodart after Radical Therapy for Prostate Cancer Study.

OBJECTIVE: To describe the Avodart after Radical Therapy for prostate cancer Study (ARTS), investigating the use of dutasteride (a dual 5alpha-reductase inhibitor that suppresses intraprostatic dihydrotestosterone, reduces tumour volume and improves other markers of tumour regression in prostate cancer) to prevent or delay disease progression in patients with biochemical recurrence after therapy with curative intent. PATIENTS AND METHODS: An increasing serum prostate-specific antigen (PSA) level after radical prostatectomy (RP) or radiotherapy (RT) is indicative of recurrent prostate cancer and typically pre-dates clinically detectable metastatic disease by several years. ARTS is an ongoing European multicentre trial in which patients are stratified by previous therapy (RP with or without salvage RT vs primary RT) and randomized to double-blind treatment with dutasteride 0.5 mg or placebo once daily for 2 years. Eligible patients will have a PSA doubling time (DT) of 3-24 months. Biochemical recurrence is defined as three increases in PSA level from the nadir, with each increase > or =4 weeks apart and each PSA level > or =0.2 ng/mL, and a final PSA level of > or =0.4 ng/mL (after RP) or > or =2 ng/mL (after primary RT). Study endpoints include time to PSA doubling, time to disease progression, treatment response (PSA decrease or an increase of < or =15% from baseline), changes in PSA and PSADT, and changes in anxiety (Memorial Anxiety Scale for Prostate Cancer). CONCLUSIONS ARTS: will be the first study to evaluate the effects of dutasteride on PSADT, disease progression and treatment response in patients with biochemical failure after RP or RT, and should help to elucidate the potential role of dual 5alpha-reductase inhibition in prostate cancer.

Novel method for open-access laparoscopic port insertion using the killian nasal speculum: the lister technique.

PURPOSE: Safe insertion of the first port during laparoscopic surgery has always been problematic, from the early use of the Veress needle to the open Hasson technique. We describe a novel, safe, and well-illuminated technique of port entry using the Killian nasal speculum. This technique has been used successfully in transperitoneal laparoscopic nephrectomy as well as extraperitoneal radical prostatectomy in our department. The Killian nasal speculum has an built-in light source allowing excellent vision, and its narrow "beak" perfectly separates the fat and rectus sheath, and allows muscle splitting without the need for any other instrument or assistant. This technique has been employed in obese patients, allowing easy access, and it creates a tight, leakproof entry port. The Killian nasal speculum is available in all hospitals that offer an ear, nose, and throat service, and comes in four different sizes and lengths to suit all types of patients.