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.