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A phase II randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy with LHRH agonist or antagonist versus anti-androgen therapy with apalutamide in patients with biochemical progression after radical prostatectomy.

Date

30 Sep 2019

Session

Poster Display session 3

Presenters

Piet Dirix

Citation

Annals of Oncology (2019) 30 (suppl_5): v325-v355. 10.1093/annonc/mdz248

Authors

P. Dirix1, M. Strijbos2, K. Fransis3, N. Liefhooghe4, S. Van Bruwaene5, P. Uvin6, C. Ghysel6, D. Ost7, B. Engels8, R. Van den Begin9, F. Otte10, T. Roumeguere11, S. Palumbo12, Y. Neybuch13, V. Fonteyne14, L. Renard15, W. Everaerts16, B. Tombal17, P. Ost14, L.Y. Dirix18

Author affiliations

  • 1 Radiation Oncology, Iridium Kankernetwerk, 2610 - Antwerpen/BE
  • 2 Medical Oncology, GZA Ziekenhuizen Sint Augustinus, 2610 - Antwerp/BE
  • 3 Urology, University Hospital Antwerpen, 2650 - Edegem/BE
  • 4 Radiation Oncology, AZ Groeninge Hospital, 8500 - Kortrijk/BE
  • 5 Urology, AZ Groeninge Hospital, 8500 - Kortrijk/BE
  • 6 Urology, AZ Sint-Jan Hospital, 8000 - Brugge/BE
  • 7 Urology, Sint-Blasius Hospital, 9200 - Dendermonde/BE
  • 8 Radiation Oncology, UZ Brussel, 1090 - Jette/BE
  • 9 Radiation Oncology, Institut Jules Bordet, 1000 - Brussel/BE
  • 10 Radiation Oncology, Institute Jules Bordet, 1000 - Brussels/BE
  • 11 Urology, Erasme University Hospital-(Universite Libre de Bruxelles), 1070 - Brussels/BE
  • 12 Radiation Oncology, Hôpital Sainte Elisabeth, 5000 - Namur/BE
  • 13 Radiation Oncology, Hôpital Jolimont, 7100 - Haine-Saint-Paul/BE
  • 14 Radiation Oncology, UZ Gent, 9000 - Gent/BE
  • 15 Radiation Oncology, Cliniques Universitaires Saint Luc, 1200 - Sint-Lambrechts-Woluwe/BE
  • 16 Urology, University Hospitals Leuven - Campus Gasthuisberg, 3000 - Leuven/BE
  • 17 Medical Oncology, Cliniques Universitaires St. Luc, 1200 - Brussels/BE
  • 18 Medical Oncology, St-Augustinus Ziekenhuis, 2580 - Wilrijk/BE
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Resources

Abstract 3312

Background

Salvage radiotherapy (SRT) is a potentially curative option for patients with rising PSA (biochemical recurrence) after radical prostatectomy. Recently, success rates of SRT were significantly improved through the use of concomitant anti-androgen (AAT) or androgen-deprivation (ADT) therapy. In RTOG 96-01, 2 years of bicalutamide 150 mg resulted in a 5% OS benefit at 12-years. In GETUG-AFU 16, 5-year progression-free survival was significantly improved when SRT was combined with 6 months of an LHRH agonist. Based on GETUG-AFU 16, most European urologists and (radiation) oncologists now combine SRT with at least 6 months of ADT. However, ADT comes with several serious side-effects, both physical (cardiovascular, metabolic, musculoskeletal) and psychological (sexual, emotional and cognitive). Considering RTOG 96-01, and in view of new AAT options, it appears worthwhile to look for alternatives. In that respect, apalutamide (ERLEADA®), a next-generation anti-androgen, is an interesting candidate.

Trial design

This is a phase II randomized, open-label study comparing SRT in combination with 6 months of LHRH (ant)agonist (arm A) versus 6 cycles of apalutamide 240 mg daily (each cycle is 28 +/- 2 days) (arm B) in hormone-naïve patients with biochemical recurrence (PSA > 0.1 µg/L at least 8 weeks after radical prostatectomy). Patients with severe erectile dysfunction are excluded. All subjects will receive SRT as standard of care and will be randomly assigned in a 1:1 ratio to arm A or B. Primary objective is to compare sexual function, based on the EPIC-26 sexual domain score, at 9 months (i.e. 3 months after the end of hormonal treatment). Secondary endpoints include general quality of life (EPIC-26, EORTC QLQ C30 and PR25, FACT-P), acute as well as late toxicity (CTCAE version 5.0), and PSA (complete) response rates (i.e. decline from baseline in PSA level of 80% (90%) or greater). The trial was approved by the local ethics committee on April 2nd 2019 and started recruiting immediately thereafter.

Clinical trial identification

NCT03899077; 2018-004365-13.

Editorial acknowledgement

Legal entity responsible for the study

GZA Hospitals.

Funding

Janssen.

Disclosure

All authors have declared no conflicts of interest.

Resources from the same session

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