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.


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.
Schröder
Fritz H
FH
Erasmus MC, Rotterdam, the Netherlands. secr.schroder@erasmusmc.nl
Bangma
Chris H
CH
Wolff
Johannes M
JM
Alcaraz
Antonio
A
Montorsi
Francesco
F
Mongiat-Artus
Pierre
P
Abrahamsson
Per-Anders
PA
McNicholas
Tom A
TA
Castro
Ramiro S
RS
Nandy
Indrani M
IM
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001378:Azasteroids / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D042944:Cholestenone 5 alpha-Reductase / Q000037:antagonists & inhibitors*; D018450:Disease Progression; D004311:Double-Blind Method; D000068538:Dutasteride; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000188:drug therapy*; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000628:therapy; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D001378:Azasteroids; D004791:Enzyme Inhibitors; D042944:Cholestenone 5 alpha-Reductase; D000068538:Dutasteride