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Information on clinical trials in the United States.

More Interesting Clinical Trials in The United States:

for metastatic, castrate-resistant

prostate cancer patients

 

To add to an email we distributed in November 2013, here are a few more clinical trials that may be of interest to patients in the United States. 

It is challenging to get clear details on a clinical trial in order to really make a decision.  And clinical trials are always changing – opening enrollment, and closing enrollment.  Here are several clinical trials for men who are both metastatic and castrate resistant (progressing with suppressed testosterone).  This is not an all inclusive list, but a hand-picked collection from our knowledge and experience.

A few pointers:
 
  • It can take 3 to 4 weeks to go through the screening process for a trial.  You can usually speed this up by (1) developing a relationship with the clinical trial coordinator or nurse  (2) giving them copies of your medical records personally.  Ask the trial coordinator or nurse how this 3-4 week process plays into the timing of some of the 3 and 4 week criteria below (to be off certain treatments).
     
  • Make sure the benefits outweighs the risks for you.  Ask questions about necessary testing, travel, what’s free, and what’s not.  Remember, you can pull out of a clinical trial any time you want.

     
  • Castrate-Resistant, Refractory, and Advanced mean the same thing in trials below.
Enzalutamide [Xtandi] With or Without Vaccine Therapy for Advanced Prostate Cancer

Phase 2 – All receive Xtandi
(half receive ProstVac - half do not)

Basic Eligibility Criteria
  • PSA 2.0 or greater, with 2 consecutive rises
  • Metastatic to bone or soft tissue
  • No pain, or minimal pain.
  • At least four weeks since radiation or Xofigo
  • At least six weeks since Casodex or Nilandron
  • No allergy to eggs or egg products
  • NO history of seizure
  • NO previous Zytiga
LOCATION:
Bethesda, MD
National Insitutes of Health
Contact: Laura Otten, R.N., (301) 451-1228, ottenl@mail.nih.gov
                 or Ravi Madan, M.D., (310) 496-3493, rm480i@nih.gov
 

Prostate Cancer Medically Optimized Genome Enhanced ThErapy in Castrate Resistant Patients Receiving Abiraterone Acetate Therapy (PROMOTE)

Basic Eligibility Criteria
 

  • PSA 2.0 or greater, with 2 consecutive rises
  • Metastatic to bone or soft tissue
  • At least two weeks since any radiation
  • At least four weeks since Casodex
  • At least 2 months since PROVENGE
  • At least one year since chemo, Xtandi, or ketconazole
  • NO previous Xofigo

LOCATIONS:
Rochester, MN
Mayo Clinic
Contact:
Manish Kohli, 507-538-7623,  kohli.manish@mayo.edu  
 
Scottsdale, AZ
Mayo Clinic
Contact: Alan H. Bryce, 507-538-7623    
 
Jacksonville, FL
Mayo Clinic
Contact: Winston W. Tan    507-538-7623
Phase II Study of Sipuleucel-T [PROVENGE] and Indoximod for Patients With Refractory Metastatic Prostate Cancer

Phase 2 – All receive PROVENGE (half receive Indoximod - half do not)

Basic Eligibility Criteria
 
  • PSA 2.0 or greater
  • Metastatic to bone or soft tissue
  • No pain, or minimal pain.
  • No Crohn’s disease or significant gastrointestinal issues
LOCATIONS:
Chicago, IL
Univ of Illinois Medical Center
Contact: Arkadiusz Z Dudek, MD, PhD, 312-413-8878, adudek@uic.edu   

Minneapolis, MN
Masonic Cancer Center, Univ of Minnesota
Contact: Gautam Jha, M.D., 612-625-5373, jhaxx014@umn.edu
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 (Prospect)
Phase 3 – some men receive placebo

Basic Eligibility Criteria
 
  • PSA 2.0 or greater, with 2 consecutive rises
  • Metastatic to bone or lymph nodes
  • No pain, or minimal pain.
  • NO previous chemo
  • NO previous PROVENGE

LOCATIONS:  32 States

Contact:  Paul Collins, paul.collins@ppdi.com,  or  Janet Hurt, janet.hurt@bavarian-nordic.com
 
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