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. Author manuscript; available in PMC: 2019 Jul 24.
Published in final edited form as: Nat Rev Clin Oncol. 2017 Oct 17;15(3):168–182. doi: 10.1038/nrclinonc.2017.160

Table 2 |.

Selected clinical trials involving neoadjuvant ADT with pCR rates reported

Study n Predefined study entry criteria in manuscript Treatment arm(s) pCR rate MRD (≤ 5 mm) MRD (<0.25 cm3) pCR defined? MRD defined?
T-stage Gleason score Number of cores Baseline PSA Imaging criteria
Labrie et al. (1997)110 161 Yes No No No No Leuprolide + flutamide for 3 months 7% NA NA No No
Van Der Kwast et al.(1999)111 47 No No No No No Leuprolide + flutamide for 3 months 0% NA NA No No
Leuprolide + flutamide for 6 months 9%
G leave et al. (2001)112 547 No* No No No No Leuprolide + flutamide for 3 months 5% NA NA Yes No
Leuprolide + flutamide for 8 months 9%
Klotz et al. (2003)113 213 Yes No No Yes No Cyproterone for 3 months 0% NA NA No No
TAPS (2014)114 35 Yes Yes No No No Goserelin + dutasteride for 3 months 0% NR 17% No Yes
Goserelin + bicalutamide + dutasteride for 3 months 10% NR 20%
Goserelin + bicalutamie + dutasteride + ketoconazole for 3 months 8% NR 23%
NeoAbi (2014)53 56 Yes Yes No Yes No LHRH agonist for 6 months + abiraterone for 3 months 4% 0% 44% No Yes
LHRH agonist for 6 months + abiraterone for 6 months 10% 14% 52%
NeoEnza (2015)115 48 Yes Yes Yes Yes No Enzalutamide for 6 months 0% 0% 36% Yes Yes
Enzalutamide + dutasteride + leuprolide for 6 months 4% 13% 74%
MDACC (2016)116§ 65 Yes Yes No Yes No Abiraterone + enzalutmide + LHRH agonist for 6 months 2% NR NR No Yes
Abiraterone + LHRH agonists for 6 months 5%
30 Yes Yes Yes Yes Yes Leuprolide + enzalutamide 10% 55% NR NA NA
Leuprolide + enzalutamide + abiraterone 15% 50%

ADT, androgen-derpivation therapy; LHRH, luteinizing-hormone releasing hormone; NA, not available; NR, not reported; pCR, pathological complete response; PSA, prostate specific antigen

*

Patients were stratified for Gleason score and baseline serum PSA level

MRD defined as <0.2 cm3 in this study

§

Full study not reported, data were obtained from abstract.