TroVax® In Subjects With Hormone Refractory Prostate Cancer (HRPC)

Phase 2

Terminated

• Conditions: Hormone Refractory Prostate Cancer
• Interventions: Drug: Docetaxel; Drug: TroVax

• Registration Number: NCT01194960
• Lead Sponsor: Oxford BioMedica

Brief Summary

Based on both pre-clinical and clinical data, it may be advantageous to administer a cancer vaccine before chemotherapy to enhance immune responses, thus leading to a more effective therapeutic approach for subjects with metastatic HRPC. This clinical study will evaluate the role of combination therapy of TroVax® plus Docetaxel vs. Docetaxel alone on the progression free survival (PFS) of subjects with HRPC.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Disposition First Submitted: 2020-09-29
• Disposition First Submitted QC: 2020-09-29
• Status Verified: 2020-10
• Disposition First Posted: 2020-10-08
• Last Update Submitted: 2020-10-08
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TroVax plus Docetaxel	Docetaxel	Subjects will receive both TroVax plus 10 cycles of Docetaxel.
Docetaxel Alone	Docetaxel	Subjects will receive 10 cycles of Docetaxel alone until toxicity or progression.
TroVax plus Docetaxel	TroVax	Subjects will receive both TroVax plus 10 cycles of Docetaxel.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	Week 37	To establish whether the incidence of progression-free survival (as defined by the absence of progression assessed by both RECIST and PCWG2 criteria) at week 37 in the TroVax® plus Docetaxel treatment arm is higher than the incidence in the Docetaxel alone treatment arm.

Secondary Outcome Measures

Name	Time	Method
Clinical progression-free survival	37 weeks	To establish whether the incidence of clinical progression-free survival (defined by the absence of progression assessed by RECIST criteria alone) at week 37 in the TroVax® plus Docetaxel treatment arm is higher than the incidence in the Docetaxel alone treatment arm.

Trial Locations

Locations (7)

San Bernardino Urology; 🇺🇸 San Bernardino, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

GU Research Network; 🇺🇸 Omaha, Nebraska, United States

New York University Cancer Institute; 🇺🇸 New York, New York, United States

Gabrail Cancer Center Research; 🇺🇸 Canton, Ohio, United States

Charleston Hematology Oncology Associates; 🇺🇸 Charleston, South Carolina, United States