Phase III Study of DCVAC Added to Standard Chemotherapy for Men with Metastatic Castration Resistant Prostate Cancer

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male 18 years and older
  • Histologically or cytologically confirmed prostate adenocarcinoma
  • Presence of skeletal, and/or soft-tissue/visceral/nodal metastasis
  • Disease progression despite Androgen Deprivation Therapy
  • Maintenance of castrate conditions
  • Life expectancy of at least 6 months based on Investigator´s judgment.
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  • At least 4 weeks after surgery or radiotherapy
  • A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy
  • Recovery from primary local surgical treatment, radiotherapy or orchiectomy

Exclusion Criteria:

  • Confirmed brain and/or leptomeningeal metastases
  • Current symptomatic cord compression requiring surgery or radiation therapy
  • Prior chemotherapy for prostate cancer
  • Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone)
  • Systemic corticosteroids at doses greater than 40mg hydrocortisone daily or equivalent for any reason other than treatment of prostate cancer (PCa) within the previous 6 months
  • Systemic immunosuppressive therapy for any reason
  • Treatment with immunotherapy against PCa within the previous 6 months prior to randomization
  • Clinically significant cardiovascular disease
  • Active autoimmune disease requiring treatment
  • Uncontrolled co-morbidities
  • Participation in a clinical trial using experimental therapy within the last 4 weeks prior to randomization
  • Participation in a clinical trial using immunological experimental therapy (e.g. monoclonal antibodies, cytokines or active cellular immunotherapies) within the last 6 months prior to randomization

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Alan Bryce, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20154277

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