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Table 2 Outcomes of selected trials

From: A review of new hormonal therapies for prostate cancer in black men: is there enough data?

Trial (NCT)

Population

Comparison

Primary

Outcomes

Secondary

Outcomes

Results

Adverse Events

Tsao et al. 2016

NCT01735396 [12]

mCRPC black men

Antitumor activity (defined by a 30% decline in PSA level)

90% antitumor activity

No patients discontinuing treatment because of AE

Higher common AE

Ryan et al. 2018

NCT01314118 [13]

M0 CRPC black men

mCRPC white men

Rate of 50% PSA decline

Time to PSA and to Rx progression

Primary: No data

Secondary: No difference

NR

Ramalingam et al. 2017 [14]

mCRPC black men

mCRPC white men (2 W:1B)

Rate of 90, 50 and 30% PSA decline

Time on therapy, time to PSA progression, OS

Primary: 90% PSA did not differ between B and W, but 50 and 30% decline were significantly higher among B

Secondary: time on therapy, time to PSA progression and OS did not differ between B and W

NR

Leuva et al. 2019 [15]

mCRPC black men

mCRPC white men

Overall survival

Efficacy of treatment using tumor growth and regression, were calculated using serial PSA values

B Patients treated with Abi only or with Abi first showed superior survival than W patients:

25.4 months vs. 22.4 months

(p = 0.02)

Abi efficacy was 60% higher in B than in W patients

(p = 0.02)

No difference between B and W patients treated with Enza

NR

  1. B Black, W White, NR Not Reported, AE Adverse events, Abi abiraterone
  2. * Theory for growth and regression, that uses a novel set of equations, was validated in > 20,000 patients. G was an excellent biomarker of overall survival