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.
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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
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- 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
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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
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