Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Genitourinary tumours, prostate

4679 - Docetaxel (D) with androgen suppression (AS) for high-risk localized prostate cancer (HrPC) patients (pts) who relapsed PSA after radical prostatectomy (RP) and/or radiotherapy (RT): a randomized phase III trial.


08 Sep 2017


Genitourinary tumours, prostate


Cytotoxic Therapy;  Surgical Oncology;  Radiation Oncology;  Prostate Cancer


Stephane Oudard


Annals of Oncology (2017) 28 (suppl_5): v269-v294. 10.1093/annonc/mdx370


S. Oudard1, I. Latorzeff2, A. Caty3, L. Miglianico4, E. Sevin5, A. Hardy Bessard6, R. Delva7, F. Rolland8, C. Chevreau9, F. Priou10, P. Beuzeboc11, G. Gravis12, C. Linassier13, P. Gomez14, E. Voog15, P. Chinet14, X. Muracciole16, C. Abraham Jaillon17, R. Elaidi18, S. Culine19

Author affiliations

  • 1 Oncology Department, Hopital European George Pompidou, 75015 - Paris/FR
  • 2 Oncologie, Clinique du Parc, 31500 - Toulouse/FR
  • 3 Medical Oncology, Hôpital Saint-Lambret, 59020 - Lille Cedex/FR
  • 4 Oncology, CHP Saint-Grégoire, 35760 - St. Grégoire/FR
  • 5 Oncology, Centre Francois Baclesse, 14076 - Caen/FR
  • 6 Medical Oncology, Centre CARIO - HPCA, 22190 - Plérin sur mer/FR
  • 7 Oncology, Centre Paul Papin, 49100 - Angers/FR
  • 8 Oncology, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 9 Medical Oncology, Institut Universitaire du Cancer -Toulouse- Oncopole, 31059 - Toulouse/FR
  • 10 Oncology, CHD Vendee - Hopital Les Oudairies, 85925 - La Roche sur Yon/FR
  • 11 Medical Oncology, Institut Curie, 75248 cedex5 - Paris/FR
  • 12 Medical Oncology, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 13 Medical Oncology, CHRU Bretonneau, 37044 - Tours/FR
  • 14 Oncology, Centre Frédéric Joliot, 76000 - Rouen/FR
  • 15 Oncology, Clinique Victor Hugo Le Mans, 72000 - Le Mans/FR
  • 16 Oncology, Hôpital de la Timone, 13385 - Marseille/FR
  • 17 Oncology, Centre Hospitalier de Versailles - Hopital Andre Mignot, 78157 - Le Chesnay/FR
  • 18 Medical Oncology, ARTIC - Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, 75015 - Paris/FR
  • 19 Medical Oncology, Hôpital St. Louis, 75010 - Paris/FR


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 4679


HrPC pts with PSA relapse after local therapy may have a poor prognosis and AS may be a therapeutic option. D+AS is standard of care in hormone-naive metastatic PC. We evaluated the benefit of D+AS in HrPC pts with PSA relapse after RP and/or RT.


Multicenter, randomized phase 3 study (NCT00764166) comparing AS (triptorelin, every 3 months for 1 year) versus AS+D (70 mg/m2 Q3W, 6 cycles). To be enrolled, pts needed ≥ 3 rising PSA values >0.2ng/mL (after RP) or > 1ng/mL above nadir (after RT) modified by nadir + 2ng/ml (RTOG-ASTRO Phoenix, 2006) and ≥ 1 of the following criteria: Gleason ≥8, PSA doubling time (PSADT) ≤6 mths, PSA velocity >0.75 ng/mL/year, positive surgical margins (SM), pN1, time from curative therapy to PSA relapse ≤12 months. Pts were stratified on type of local treatment (RP or RT) and PSADT (≤ or > 6 mths). Primary endpoint was PSA-PFS defined by a PSA above 0.2ng/ml and rise ≥ 50% from baseline confirmed by 2 subsequent values. Secondary endpoints were PSA response (decrease ≥50%), radiological progression (rPFS), overall survival (OS) and safety.


between 2003-2007, 250 pts (median age 65 years), were randomized to AS+D (arm A, n = 125) or AS (arm B, n = 125). Local treatment: RP (95 pts, 38%), RT (69 pts, 28%) or RP+RT (86 pts, 34%). Risk factors were as follows: Gleason ≥8: 29%, PSADT≤ 6 mths 54%, PSA velocity >0.75 ng/mL/yr 84%, positive SM 37%, pN1 4%, PSA relapse ≤12 mths 45%. 58% of pts had ≥3 risk factors. Six pts had a PSA >20 ng/ml at baseline. There was no significant difference in PSA response (94% vs 98%), PSA-PFS and rPFS between 2 arms (table). Median OS was not mature. Most common grade ≥3 toxicities in arm A were neutropenia (58%), febrile neutropenia (8%) and hair loss (4%). AS toxicities were mainly grade 2 hot flushes (47%) and depression (11%).Table:


AS + D (n = 125)AS alone (n = 125)HR (95%)p-value
PSA-PFS (months)20.7 [19.2-21.5]18.6 [17.6-20.2]0.85 (0.62-1.16)0.31
rPFS (years)8.8 [7.7-10.2]9.7 [6.9-10.9]1.01 (0.72-1.40)0.95
25eme percentile (OS, years) (0.76-1.77)0.49


AS+D failed to improve PSA-PFS, rPFS in HrPC pts relapsing PSA after local therapy.

Clinical trial identification


Legal entity responsible for the study

Stéphane OUDARD, MD, PhD


Sanofi Aventis


S. Oudard: Honoraria from Sanofi, Novartis, Roche, Ipsen, BMS outside submited work L. Miglianico, E. Sevin, A-C. Hardy Bessard: Fees from Sanofi. C. Chevreau, C. Linassier, S. Culine: Fees from Sanofi, Astellas, Janssen. F. Priou: Fees from Sanofi. P. Beuzeboc: Fees from Sanofis, Astellas, Janssen. G. Gravis: Travel paid by Sanofi, Astellas, Janssen All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.