Salvage Radiotherapy Versus Hormone Therapy for Prostate-specific Antigen Failure After Radical Prostatectomy: A Randomised, Multicentre, Open-label, Phase 3 Trial (JCOG0401)
Aged
Anilides
/ therapeutic use
Antineoplastic Agents
/ therapeutic use
Gonadotropin-Releasing Hormone
/ agonists
Humans
Male
Nitriles
/ therapeutic use
Prostate-Specific Antigen
/ blood
Prostatectomy
/ methods
Prostatic Neoplasms
/ blood
Salvage Therapy
Tosyl Compounds
/ therapeutic use
Treatment Failure
Prostate-specific antigen failure
Radical prostatectomy
Salvage therapy
Journal
European urology
ISSN: 1873-7560
Titre abrégé: Eur Urol
Pays: Switzerland
ID NLM: 7512719
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
received:
22
06
2019
accepted:
29
11
2019
pubmed:
24
12
2019
medline:
22
6
2021
entrez:
24
12
2019
Statut:
ppublish
Résumé
No standard therapy has been established for localised prostate cancer patients with prostate-specific antigen (PSA) failure after radical prostatectomy (RP). To determine whether radiotherapy ± hormone therapy is superior to hormone therapy alone in such patients. This study is a multicentre, randomised, open-label, phase 3 trial. Patients with localised prostate cancer whose PSA concentrations had decreased to <0.1 ng/ml after RP, and then increased to 0.4-1.0 ng/ml, were randomised to the salvage hormone therapy (SHT) group (80 mg bicalutamide [BCL] followed by luteinising hormone-releasing hormone agonist in case of BCL failure) or the salvage radiation therapy (SRT) ± SHT group (64.8 Gy of SRT followed by the same regimen as in the SHT group in case of SRT failure). From May 2004 to May 2011, 210 patients (105 in each arm) were registered, with the median follow-up being 5.5 yr. The primary endpoint was time to treatment failure (TTF) of BCL. TTF of BCL was significantly longer in the SRT ± SHT group (8.6 yr) than in the SHT group (5.6 yr; hazard ratio 0.56, 90% confidence interval [0.40-0.77]; one-sided p = 0.001). Thirty-two of 102 patients (31%) in the SRT ± SHT group did not have SRT treatment failure. However, clinical relapse-free survival and overall survival did not differ between the arms. The most frequent grade 3-4 adverse event was erectile dysfunction (83 patients [80%] in the SHT group vs. 76 [74%] in the SRT ± SHT group). Limitations include the short follow-up periods and surrogate endpoint setting to allow definitive conclusions. Initial SRT prolongs TTF of BCL in patients with post-RP PSA failure, indicating that SRT ± SHT is more beneficial than SHT alone. Patients who have prostate-specific antigen failure after radical prostatectomy benefit from salvage radiation therapy prior to salvage hormone therapy.
Sections du résumé
BACKGROUND
No standard therapy has been established for localised prostate cancer patients with prostate-specific antigen (PSA) failure after radical prostatectomy (RP).
OBJECTIVE
To determine whether radiotherapy ± hormone therapy is superior to hormone therapy alone in such patients.
DESIGN, SETTING, AND PARTICIPANTS
This study is a multicentre, randomised, open-label, phase 3 trial. Patients with localised prostate cancer whose PSA concentrations had decreased to <0.1 ng/ml after RP, and then increased to 0.4-1.0 ng/ml, were randomised to the salvage hormone therapy (SHT) group (80 mg bicalutamide [BCL] followed by luteinising hormone-releasing hormone agonist in case of BCL failure) or the salvage radiation therapy (SRT) ± SHT group (64.8 Gy of SRT followed by the same regimen as in the SHT group in case of SRT failure). From May 2004 to May 2011, 210 patients (105 in each arm) were registered, with the median follow-up being 5.5 yr.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The primary endpoint was time to treatment failure (TTF) of BCL.
RESULTS AND LIMITATIONS
TTF of BCL was significantly longer in the SRT ± SHT group (8.6 yr) than in the SHT group (5.6 yr; hazard ratio 0.56, 90% confidence interval [0.40-0.77]; one-sided p = 0.001). Thirty-two of 102 patients (31%) in the SRT ± SHT group did not have SRT treatment failure. However, clinical relapse-free survival and overall survival did not differ between the arms. The most frequent grade 3-4 adverse event was erectile dysfunction (83 patients [80%] in the SHT group vs. 76 [74%] in the SRT ± SHT group). Limitations include the short follow-up periods and surrogate endpoint setting to allow definitive conclusions.
CONCLUSIONS
Initial SRT prolongs TTF of BCL in patients with post-RP PSA failure, indicating that SRT ± SHT is more beneficial than SHT alone.
PATIENT SUMMARY
Patients who have prostate-specific antigen failure after radical prostatectomy benefit from salvage radiation therapy prior to salvage hormone therapy.
Identifiants
pubmed: 31866092
pii: S0302-2838(19)30896-6
doi: 10.1016/j.eururo.2019.11.023
pii:
doi:
Substances chimiques
Anilides
0
Antineoplastic Agents
0
Nitriles
0
Tosyl Compounds
0
Gonadotropin-Releasing Hormone
33515-09-2
bicalutamide
A0Z3NAU9DP
Prostate-Specific Antigen
EC 3.4.21.77
Types de publication
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
689-698Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2019. Published by Elsevier B.V.