A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Prostate Cancer Metastatic

In brief

The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.

Key facts

Study ID

NCT01322490

Run by

Bavarian Nordic

People needed

1297

Starts

2011-11-28

Expected to finish

2017-12-15

Last updated by the study team

2019-09-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
• Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).
• Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer.
• OR
• PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria).
• Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated).

You may not qualify if…

• Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per week is allowed).
• Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo.
• Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F.
• History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin.
• Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
• History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis.

Where it is running

• Scottsdale Healthcare — Scottsdale, Arizona, United States
• Alta Bates Summit Medical Center — Berkeley, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Prostate Oncology Specialists, Inc. — Marina del Rey, California, United States
• Desert Hematology-Oncology — Rancho Mirage, California, United States
• San Bernardino Urological Associates — San Bernardino, California, United States
• San Diego Clinical Trials — San Diego, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• VA San Diego Healthcare System — San Diego, California, United States
• Stanford Advanced Medical Center — Stanford, California, United States
• University of Colorado — Aurora, Colorado, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Washington Cancer Institute — Washington D.C., District of Columbia, United States
• South Florida Medical Research — Aventura, Florida, United States
• Manatee Medical Research Institute, LLC — Bradenton, Florida, United States
• Florida Urology Physicians — Fort Myers, Florida, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• Pinellas Urology, Inc. — St. Petersburg, Florida, United States
• James A Haley Veteran Affairs Medical Center — Tampa, Florida, United States
• Palm Beach Cancer Institute — West Palm Beach, Florida, United States
• North Idaho Urology — Coeur d'Alene, Idaho, United States
• Jesse Brown VA — Chicago, Illinois, United States
• First Urology PSC — Jeffersonville, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Alaska Clinical Research Center, Llc — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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