scholarly journals Orteronel Switch Maintenance Therapy in Metastatic Castration Resistant Prostate Cancer After First-Line Docetaxel: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (SAKK 08/11)

The Prostate ◽  
2016 ◽  
Vol 76 (16) ◽  
pp. 1519-1527 ◽  
Author(s):  
Richard Cathomas ◽  
Simon J. Crabb ◽  
Michael Mark ◽  
Ralph Winterhalder ◽  
Christian Rothermundt ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Maintenance Therapy ◽  
Controlled Trial ◽  
Castration Resistant Prostate Cancer ◽  
First Line ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Castration Resistant ◽  
Switch Maintenance Therapy

Randomized, Double-Blind, Placebo-Controlled Trial of Epoetin Alfa in Men With Castration-Resistant Prostate Cancer and Anemia

2009 ◽  
Vol 27 (4) ◽  
pp. 644-646 ◽  
Author(s):  
Eric Winquist ◽  
Jim A. Julian ◽  
Malcolm J. Moore ◽  
Abdenour Nabid ◽  
Jinka Sathya ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Controlled Trial ◽  
Epoetin Alfa ◽  
Castration Resistant Prostate Cancer ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Castration Resistant

Mixed 20-peptide cancer vaccine in combination with docetaxel and dexamethasone for castration-resistant prostate cancer: A randomized, double-blind, placebo-controlled, phase 2 trial.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 214-214 ◽  
Author(s):  
Masanori Noguchi ◽  
Gaku Arai ◽  
Shin Egawa ◽  
Chikara Ohyama ◽  
Seiji Naito ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Vaccine ◽  
Specific Antigen ◽  
Human Leukocyte ◽  
Phase 2 ◽  
Castration Resistant Prostate Cancer ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Phase 2 Trial ◽  
Castration Resistant

214 Background: A novel cancer vaccine consisting of 20 mixed peptides (KRM-20) was designed to induce cytotoxic T lymphocytes (CTL) against twelve different tumor-associated antigens. The aim of this phase 2 trial was to examine whether KRM-20 in combination with docetaxel and dexamethasone enhances anti-tumor effects in patients with castration-resistant prostate cancer (CRPC). Methods: In this double-blind, placebo-controlled, randomized, phase 2 study, we enrolled chemotherapy-naïve patients with progressive CRPC from 10 medical centers in Japan. Eligible patients were randomly assigned 1:1 centrally to either KRM-20 combined with docetaxel and dexamethasone or placebo with docetaxel and dexamethasone. Patients initially received 5 weekly subcutaneous KRM-20 (20 mg) or placebo injections with daily oral dexamethasone (1 mg) following 5 courses of docetaxel (70 mg/m2 every 3 weeks). The primary endpoint was to compare each treatment for prostate-specific antigen (PSA) decline. Results: Between Jul 31, 2013 and Jul 11, 2014, 51 patients were enrolled to the trial: 25 were assigned to the KRM-20 arm, and 26 were allocated to the placebo arm. Mean % PSA levels from baseline in the KRM-20 arm significantly decreased during the treatment compared witht those in the placebo arm ( P = 0.028, MANOVA). Human leukocyte antigen matched peptide-specific immunoglobulin G ( P = 0.018) and CTL ( P = 0.007) responses in the KRM-20 arm significantly increased after the treatment. The appearance of myeloid-derived suppressor cells in the KRM-20 arm significantly decreased after the treatment ( P = 0.007). The addition of KRM-20 did not result in increased toxicity. There was no between-group differences in progression-free or overall survival. Conclusions: These findings suggest potential clinical benefits for the combined use of KRM-20 with docetaxel and dexamethasone in patients with CRPC. Clinical trial information: UMIN000011028.

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