Effect of docetaxel added to bicalutamide in Hormone-Naïve non-metastatic prostate cancer with rising PSA, a randomized clinical trial (SPCG-14)

Authors

  • Andreas Josefsson a Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; b Wallenberg Center for Molecular Medicin, Umeå University, Umeå, Sweden; c Department of Urology and Andrology, Institute of surgery and perioperative Sciences, Umeå University, Umeå, Sweden
  • Åsa Jellvert d Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; e Region Västra Götaland, NU Hospital Group, Department of Surgery, Uddevalla, Sweden; f Department of Oncology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden
  • Erik Holmberg d Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; g Regional Cancer Centre West, Gothenburg, Sweden
  • Klaus Brasso h Copenhagen Prostate Cancer Center, Department of Urology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
  • Peter Meidahl Petersen i Department of Oncology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
  • Sirpa Aaltomaa j Department of Urology, Kuopio University Hospital, Kuopio, Finland
  • Marjaana Luukkaa k Department of Oncology, Turku University Hospital, Turku, Finland
  • Paul Verhagen l Department of Urology, Erasmus Medical Centre, Rotterdam, the Netherlands
  • Ronald de Wit m Department of Medical Oncology, Erasmus University Medical Centre Cancer Institute, Rotterdam, the Netherlands
  • Göran Ahlgren n Department of Urology, Lund University, Skåne University Hospital, Sweden
  • Ove Andrén o School of Medical Sciences, Örebro University, Örebro, Sweden
  • Enrique Castellanos p Department of Oncology, Karolinska University Hospital, Stockholm, Sweden
  • Mihalj Seke q Centrallasarettet Växjö, Växjö, Sweden
  • Anders Widmark r Department of Radiation Sciences, Umeå University, Umeå, Sweden
  • Jan-Erik Damber a Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

DOI:

https://doi.org/10.1080/0284186X.2023.2199940

Keywords:

Prostate cancer, docetaxel, randomized clinical trial, psa relapse, bicalutamide

Abstract

Background

Historically, endocrine therapy was used in a range of scenarios in patients with rising PSA, both as a treatment for locally advanced non-metastatic prostate cancer and PSA recurrence following curative intended therapy. In the present study the objective was to investigate if chemotherapy added to endocrine therapy could improve progression-free survival (PFS).

Materials and Methods

Patients with hormone-naïve, non-metastatic prostate cancer and rising prostate-specific antigen (PSA), enrolled from Sweden, Denmark, the Netherlands, and Finland, were randomized to long-term bicalutamide (150 mg daily) or plus docetaxel (75 mg/m2, q3w, 8–10 cycles) without prednisone, after stratification for the site, prior local therapy or not, and PSA doubling time. The primary endpoint was 5-year PFS analyzed with a stratified Cox proportional hazards regression model on intention to treat basis.

Results

Between 2009 and 2018, a total of 348 patients were randomized; 315 patients had PSA relapse after radical treatment, 33 patients had no prior local therapy. Median follow-up was 4.9 years (IQR 4.0–5.1). Adding docetaxel improved PFS (HR 0.68, 95% CI 0.50–0.93; p = 0.015). Docetaxel showed an advantage for patients with PSA relapse after prior local therapy (HR 0.67, 95% CI 0.49–0.94; p = 0.019). One event of neutropenic infection/fever occurred in 27% of the patients receiving docetaxel. Limitations were slow recruitment, lack of enrolling patients without radical local treatment, and too short follow-up for evaluation of overall survival in patients with PSA relapse.

Conclusion

Docetaxel improved PFS in patients starting bicalutamide due to PSA relapse after local therapy or localized disease without local therapy. Confirmatory studies of the efficacy of docetaxel in the setting of PSA-only relapse in addition to endocrine therapies may be justified if longer follow-up will show increased metastatic-free survival.

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Published

2023-04-03

How to Cite

Josefsson, A., Jellvert, Åsa, Holmberg, E., Brasso, K., Meidahl Petersen, P., Aaltomaa, S., … Damber, J.-E. (2023). Effect of docetaxel added to bicalutamide in Hormone-Naïve non-metastatic prostate cancer with rising PSA, a randomized clinical trial (SPCG-14). Acta Oncologica, 62(4), 372–380. https://doi.org/10.1080/0284186X.2023.2199940

Issue

Vol. 62 No. 4 (2023): Acta Oncologica

Section

Articles