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. Author manuscript; available in PMC: 2019 Nov 1.
Published in final edited form as: Urol Oncol. 2018 Oct 9;36(11):475–487. doi: 10.1016/j.urolonc.2018.07.020

Table 1.

Trial comparisons.

Study Regimen Inclusion
criteria; Any
of the below
Local
therapy
Number of
patients who
completed
CTX and
underwent
local therapy
Median
follow-
up time
(months)
Percent
with
recurrence*
Neoadjuvant CTX

Clark et al, 2001; Cleveland Clinic1 Estramustine + etoposide × 3 cycles (28 day cycles) T2b-T3; GS ≥8; PSA ≥15 RP 18 14 12

Hussain et al, 2003; Karmanos and Michigan12 Docetaxel + estramustine q21days for 3–6 cycles T2b-T3; GS ≥8; PSA ≥15 RP or RT 28 130 64

Ryan et al, 2004; Memorial Sloan Kettering39 Vinblastine (6 weeks on, 2 weeks off) + estramustine × 2 neoadjuvant cycles, followed by concurrent vinblastine and estramustine with RT GS ≥8 and PSA ≥10; GS ≥7 and PSA ≥20; T3 and PSA ≥20; T4; N1 RT 23 60 65

Febbo et al, 2005; Dana Farber3 Weekly docetaxel × 6 months T3; GS ≥8; PSA ≥20 RP 19 26.5 63.2

Vuky et al, 2009; Virginia Mason Medical Center15 Docetaxel (3 weeks on 1 week off) and daily gefitinib × two months T2b-T3; GS ≥8; PSA ≥20 RP 22 28 34

Ross et al, 2012; Prostate Cancer Clinical Trials Consortium16 Docetaxel × 6 (q21 days) with bevacizumab (q21 days) given with the first 5 cycles T3; GS ≥8; PSA ≥20; PSA velocity >2 ng/mL/y RP 37 N/A 49

Zhao et al, 2015; Cleveland Clinic6 Weekly docetaxel × 6 weeks T2b-T3; GS≥8; PSA ≥15 RP 28 49.5 57

Bergstrom et al, 2017; Oregon/VA Portland/Washington8 Docetaxel (weekly) + mitoxantrone (3 out of 4 weeks) × 4 months T2c-T3a; GS ≥4+3; PSA ≥15 RP 54 120 63

Neoadjuvant CTX + ADT

Pettaway et al, 2000; MD Anderson20 LHRH agonist and antiandrogen + alternating cycles (× 12 weeks) of ketoconazole + doxorubicin or vinblastine + estramustine T3; GS 7 with PSA ≥10; T1-2 with GS ≥8 RP 33 13 31

Konety et al, 2004; Memorial Sloan Kettering18 LHRH agonist + 4–6 cycles of carboplatin, paclitaxel, and estramustine ≥T3; GS ≥8; PSA ≥20 RP 35 29 55

Prayer-Galetti et al, 2007; Italy21 LHRH agonist + docetaxel (q21 days) and estramustine × 4 cycles ≥T3; GS ≥8; PSA ≥15 RP 18 53 58

Kelly et al, 2008; CALGB 9981146 LHRH agonist + paclitaxel weekly, carboplatin monthly, and estramustine × 4 cycles ≥T3b; GS ≥7 and PSA >20 RT 27 38 70

Chi et al, 2008; Canadian multicenter17 LHRH agonist and antiandrogen + docetaxel (6 weeks with 3 or on 2 weeks off) for 3 cycles ≥T3; GS ≥8; PSA ≥20; GS 7 with 3 or more positive cores; PSA ≥10 with 3 or more positive cores RP 64 42.7 30

Sella et al, 2008; Israel22 LHRH agonist and antiandrogen + docetaxel (q21days) and estramustine × 4 cycles ≥T2c; GS ≥8; PSA ≥20 RP 22 23.6 45.4

Mellado et al, 2009; Spain45 LHRH agonist and antiandrogen + docetaxel (3 weeks on, 1 week off) × 3 cycles T3; T1c-T2 with GS ≥4+3 or PSA >20 RP 51 35 41.2

Narita et al, 2012; Akita University, Japan19 LHRH agonist and antiandrogen + docetaxel (weekly) and estramustine × 6 weeks ≥T3; GS ≥9; PSA ≥15 RP 18 18 16.7

Thalgott et al, 2014; Germany23 LHRH agonist and antiandrogen >40% 5-yr biochemical recurrence risk62 RP 29 48.6 55.2

Fizazi, et al. 2015; GETUG 1247 LHRH agonist alone LHRH agonist + docetaxel (q3 weeks) and estramustine × 4 cycles ≥T3; GS ≥8; vs. PSA >20; N1 RP or RT 206 vs. 207 105.6 54 vs. 43

Adjuvant CTX

Schmidt et al, 2006; National Prostatic Cancer Project—RP Protocol49 Cyclophosphamide q3weeks × 2 years vs. estramustine × 2 years vs. observation T2c – T3b; N1 RP 184 120 56 vs. 46 vs. 46

Schmidt et al, 2006; National Prostatic Cancer Project—RT Protocol49 Cyclophosphamide q3weeks × 2 years vs. estramustine × 2 years vs. observation T2c – T3b; N1 RT 253 120 77 vs. 49 vs. 63

Kibel et al, 2007; Multicenter25 Docetaxel (3 weeks on, 1 week off) × 6 cycles >50% 3-yr biochemical recurrence RP 76 29.2 60.5

Cetnar et al, 2008; University of Pennsylvania24 Paclitaxel weekly (3 weeks on, 1 week off) and estramustine × 4 cycles ≥50% 2-year PSA failure63 RP 17 24 30

Ahlgren et al, 2016 SPCG 1253 Docetaxel q3weeks × 6 cycles vs. survellance pT2 with positive margin and GS ≥4+3; pT3b and GS >3+4; N1 and GS >3+4 RP 459 56.8 47.9 vs. 38.9

Adjuvant CTX + RT + ADT

Hussain et al, 2012; University of Maryland55 LHRH agonist + paclitaxel weekly concurrent with adjuvant RT pT3N0N+ disease or rising PSA ≥ 0.05 RP 30 74.9 37

Hurwitz et al, 2017; RTOG 062131 LHRH agonist and antiandrogen + docetaxel (q3weeks) × 6 cycles post-RP PSA nadir > 0.2 ng/mL and GS ≥7; post-RP PSA nadir of <0.2 but ≥pT3 and GS ≥8 RT 74 52.8 35.1
*

Different regimen types and lengths allow only rough comparisons due to the possibility immortal time bias. Biochemical or clinical recurrence.