Men with Metastatic Castration Resistant Prostate Cancer

Status: open

A Randomized, Double Blind, Multicenter, Parallel-Group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men with Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy.

Treatment for Prostate Cancer

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Description

The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care Chemotherapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer.

Inclusion Criteria: Histologically or cytologically confirmed prostate adenocarcinoma; Presence of skeletal or soft-tissue/visceral/nodal metastasis; ECOG Performance status 0-2. Disease progression despite ADT as indicated by: PSA increase that is ≥ 2 mg/mL and ≥ 25% above the minimum PSA as reached during ADT or above the pre-treatment level OR Progression of measurable lymph nodes (≥ 15mm) or visceral lesion measurable Exclusion Criteria: Confirmed brain and/or leptomeningeal metastases; Current symptomatic cord compression; Prior chemotherapy for prostate cancer; Treatment with anti-androgens, inhibitors of adrenal-produced androgens or other hormonal tumor-focused treatment performed on the day of screening or within previous four weeks

Sponsors

This trial is sponsored by Sotio.

Providers Associated With This Trial

Principle Investigator

Sub Investigators

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