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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

Schroeder, Fritz H. ; Bangma, Chris H. ; Wolff, Johannes M. ; Alcaraz, Antonio ; Montorsi, Francesco ; Mongiat-Artus, Pierre ; Abrahamsson, Per-Anders LU ; McNicholas, Tom A. ; Castro, Ramiro S. and Nandy, Indrani M. (2009) In BJU International 103(5). p.590-596
Abstract
To describe the Avodart after Radical Therapy for prostate cancer Study (ARTS), investigating the use of dutasteride (a dual 5 alpha-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. 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... (More)
To describe the Avodart after Radical Therapy for prostate cancer Study (ARTS), investigating the use of dutasteride (a dual 5 alpha-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. 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 >= 4 weeks apart and each PSA level >= 0.2 ng/mL, and a final PSA level of >= 0.4 ng/mL (after RP) 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 <= 15% from baseline), changes in PSA and PSADT, and changes in anxiety (Memorial Anxiety Scale for Prostate Cancer). 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 5 alpha-reductase inhibition in prostate cancer. (Less)
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author
; ; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
radical, therapy, prostate cancer, 5 alpha-reductase inhibitor, dutasteride
in
BJU International
volume
103
issue
5
pages
590 - 596
publisher
Wiley-Blackwell
external identifiers
  • wos:000263449600005
  • scopus:60449116534
ISSN
1464-4096
DOI
10.1111/j.1464-410X.2009.08373.x
language
English
LU publication?
yes
id
c06ec326-a6ec-4963-9bf5-a85816b4432c (old id 1372568)
date added to LUP
2016-04-01 11:53:42
date last changed
2021-03-24 04:49:18
@article{c06ec326-a6ec-4963-9bf5-a85816b4432c,
  abstract     = {To describe the Avodart after Radical Therapy for prostate cancer Study (ARTS), investigating the use of dutasteride (a dual 5 alpha-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. 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 &gt;= 4 weeks apart and each PSA level &gt;= 0.2 ng/mL, and a final PSA level of &gt;= 0.4 ng/mL (after RP) or &gt;= 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 &lt;= 15% from baseline), changes in PSA and PSADT, and changes in anxiety (Memorial Anxiety Scale for Prostate Cancer). 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 5 alpha-reductase inhibition in prostate cancer.},
  author       = {Schroeder, Fritz H. and Bangma, Chris H. and Wolff, Johannes M. and Alcaraz, Antonio and Montorsi, Francesco and Mongiat-Artus, Pierre and Abrahamsson, Per-Anders and McNicholas, Tom A. and Castro, Ramiro S. and Nandy, Indrani M.},
  issn         = {1464-4096},
  language     = {eng},
  number       = {5},
  pages        = {590--596},
  publisher    = {Wiley-Blackwell},
  series       = {BJU International},
  title        = {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},
  url          = {http://dx.doi.org/10.1111/j.1464-410X.2009.08373.x},
  doi          = {10.1111/j.1464-410X.2009.08373.x},
  volume       = {103},
  year         = {2009},
}