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Table 1 A summary of clinical trials with angiogenesis inhibitors in prostate cancer.

From: Angiogenesis inhibitors in the treatment of prostate cancer

Drug(s)

 

N

Population

Clinical benefit

Ref

VEGF monoclonal antibody

     

Bevacizumab 10 mg/kg q2wk × 6

Ph II

15

mCRPC

4 of 15 had PSA decline < 50%

No PSA decline > 50%

No objective responses

[30]

Bevacizumab 15 mg/kg d2

Docetaxel 70 mg/m2 q3wk

Estramustine 280 mg TID d1-5

PhII

79

mCRPC

PSA response > 50% in 77% of patients

42% with radiographic partial response

[32, 33]

Bevacizumab 10 mg/kg q3wk

Docetaxel 60 mg/m2

PhII

20

mCRPC, docetaxel failure

PSA response > 50% in 55% of patients

3 of 8 patients had objective radiographic response

[34]

Tyrosine Kinase Inhibitor

     

Sorafenib 400 mg BID

PhII

22

mCRPC,

No PSA decline > 50%

No objective radiographic responses

[36]

Sorafenib 400 mg BID

PhII

28

CRPC,

docetaxel-naïve

PSA response > 50% in 1 patient (3.6%)

No objective radiographic responses

[37]

Sorafenib 400 mg BID

PhII

55

CRPC,

docetaxel-naïve

PSA response > 50% in 2 patients (3.6%)

No objective radiographic responses

[38]

Sunitinib 50 mg/day × 4 wks of 6 wk cycle

PhII

34

CRPC

PSA response > 50% in 2 patients (5.9%)

1 objective radiographic response (2.9%)

[40]

Thalidomide

     

Thalidomide 200 mg/day

PhII

63

CRPC

PSA response > 50% in 14% of patients

No objective radiographic responses

[43]

Thalidomide 200 mg/day

PhIII

159

bCSPC

Crossover design, time to restarting intermittent ADT

Time to PSA progression favored thalidomide group

15 v 9.6 mo, p = 0.21 in first phase

17.1 v 6.6 mo, p = 0002 in second phase

[45]

Thalidomide 200 mg/day

Docetaxel 30 mg/m2 d1, 8, 15 of 28 day cycle

rPhII

75

mCRPC,

docetaxel-naïve

PSA response > 50% in 53% of thalidomide group vs

PSA response > 50% in 37% of control group (p = 0.32)

OS of 25.9 mo in thalidomide group vs

OS of 14.7 mo in control group (p = 0.0407)

[46–48]

Thalidomide 200 mg/day

Docetaxel 30 mg/m2 d1, 8, 15

Estramustine TID d1-3, 8-10, 15-17 of 28 day cycle

PhII

20

mCRPC,

docetaxel-naïve

PSA response > 50% in 90% of patients

[49]

Thalidomide 200 mg/day

Docetaxel 75 mg/m2 q3wk

Bevacizumab 15 mg/kg q3wk

PhII

60

mCRPC,

docetaxel-naïve

PSA response > 50% in 88% of patients

[50]

Pending Phase III studies

     

Docetaxel + Prednisone +/- Bevacizumab

PhIII

1050

mCRPC,

docetaxel-naïve

Preliminary results indicate no benefit in overall survival for bevacizumab arm

[35]

Docetaxel + Prednisone +/- Lenalidomide

PhIII

1015*

mCRPC,

docetaxel-naïve

Results pending

NCT00988208

Prednisone +/- Sunitinib

PhIII

819*

mCRPC, docetaxel failure

Results pending

NCT00676650

  1. *Anticipated Enrollment. mCRPC - metastatic castrate-resistant Prostate Cancer. bCRPC - biochemically recurrent castrate-resistant prostate cancer. bCSPC - biochemically recurrent castrate-sensitive prostate cancer.