Studienregister

Studienregister der Deutschen Gesellschaft für Urologie e.V.

SP005 VIABLE

AcronymISRCTNEudraCTClinicaltrials.govDRKS
SP005 VIABLE2012-002814-38: IND: 015255

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 LineChemotherapy

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

The primary objective is to show superiority of treatment with DCVAC/PCa in addition to Standard of Care Chemotherapy (docetaxel plus prednisone) over placebo in addition to Standard of Care Chemotherapy (docetaxel plus prednisone) in men with mCRPC as measured by OS.

Secondary Outcomes

The secondary objectives include assessments of safety, time to tumour progression, time to prostate-specific antigen progression, progression free survival, occurrence of skeletal related events (SRE),proportion of patients requiring second line treatment introduction and time to second line therapy and changes in quality of life (QoL).

 

Diagnosis

Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC).

Patient attributes

Age

18-99

Inclusion criteria

  • Histologically or cytologically confirmed prostate adenocarcinoma

  • Presence of skeletal or soft-tissue/visceral/nodal metastasis

  • Disease progression despite androgen deprivation therapy (ADT-> details see protocol) or

  • Progression of measurable lymph nodes (≥ 15mm) or visceral lesion measurable per RECIST v1.1 criteria (confirmation by IRF required);

  • Two or more new lesions appearing on bone scan/imaging compared with a prior scan (confirmation by IRF required)

  • Laborartory criteria see protocol

 

Exclusion criteria

  • Confirmed brain and/or leptomeningeal metastases(other visceral metastases are acceptable)
  • Prior chemotherapy for prostate cancer

  • Current symptomatic cord compression requiring

  • Patient co-morbidities: HIV, active HBV or HCV

  • more Details see protocol

 

Trial design

  • Phase III
  • Multicenter
  • Randomized
  • Double-blind
  • Placebo-controlled

Intervention

Patients receive DCVAC/PCa or placebo as a prepared study medication according to the treatment plan. All patients will receive first line Standard of Care chemotherapy (docetaxel plus prednisone).

 

Documents (password protected)

Responsibilities in overall trial

Chiltern International GmbH

    National Coordinating Investigator

    Jan Fagerberg

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