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Interesting Clinical Trials in the USA
for
Metastatic, Castrate Resistant Prostate Cancer Patients

It is challenging to get clear details on a clinical trial, which complicates the decision making process. And clinical trials are always changing – opening enrollment, and closing enrollment. 
Here are several clinical trials for men who's cancer is both metastatic and castrate resistant (progressing with suppressed testosterone).  This is not an all-inclusive list, but one that I have hand-picked from my knowledge and experience, and from currently available trials.

A few pointers:
  • It can take 3 to 4 weeks to go through the screening process for a clinical trial.  You can usually speed this up by (1) developing a relationship with the clinical trial coordinator or nurse and 
    (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.  Not all clinical trials have placebo - the trials listed here have No Placebo.
     
  • Castrate-Resistant, and Hormone-Resistant mean the same thing in trials below.

(1)  Sipuleucel-T  [PROVENGE]  With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer
Phase 2 – No Placebo (half receive radiation to bone mets - half do not)

Basic Eligibility Criteria
  1. Two consecutive rising PSA’s, at least 1 week apart
  2. No pain, or minimal pain.  No “analgesics” within last 3 weeks
  3. NO chemo in last 3 MONTHS
  4. NO more than 2 types of chemo, total
  5. NO steroids, and NO other systemic treatment within last 4 weeks
  6. NO prostate or prostate bed radiation within last 3 months
  7. NO radiation to bone within last year
For further screening and information, contact:

LOCATIONS:
Duarte, CA,
Dr. Przemyslaw Twardowski  , City of Hope
Contact: Kathy Kelly, kkelly@coh.org (800) 826-4673

 
Pasadena, CA,
Dr. Stephen Koehler, City of Hope, S. Pasadena Cancer Center    
Contact: (626) 396-2900, ask for Research Department
 
Salt Lake City, UT
Dr. Neeraj Agrawal, Univ of Utah, Huntsman Cancer Institute
Contact:  Delani (801) 585-0255  (not recruiting yet - hoping to recruit by January or February)

(2)  Sipuleucel-T  [PROVENGE] and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Phase 2 – No Placebo

Basic Eligibility Criteria
  1. PSA of 5.0 or higher
  2. No pain, or minimal pain.  No “analgesics” within last 3 weeks
  3. NO chemo within last 3 MONTHS
  4. NO more than 2 types of chemo, total
  5. NO steroids within last 4 weeks
  6. NO ketoconazole, DES, or Megace within last 4 weeks
  7. NO stopping or starting of Zometa within last 4 weeks
For further screening and information, contact:
 
LOCATION:
Dallas, TX
Dr. Raquibul Hannan, University of Texas Southwestern Medical Center
Contact:  Jean Wu, RN,
jean.wu@utsouthwestern.edu , (214) 645-8525
 


(3) Re-treatment Safety of Radium-223 Dichloride [Xofigo] in Castration-resistant Prostate Cancer With Bone Metastases
Phase 1, 2 – No Placebo

Basic Eligibility Criteria

  1. Patient has already received the full 6 treatments of Xofigo – this trial is to treat more
  2. Finished Xofigo 6 treatment cycle more than 30 days ago
  3. NO enlarged lymph nodes greater than 6 cm
  4. NO visceral metastases (lung, liver, soft tissue) greater than 1 cm
  5. NO brain metastases
  6. NO chemo since last Xofigo treatment cycle
For further screening and information, contact:

LOCATION:
New Orleans, LA
Dr. Oliver Sartor, Tulane University

Contact:  Patrick Cotogno, pcotogno@tulane.edu, (504) 988-6542


(4)  Trial of Cabozantinib (XL184) in Castrate-Resistant Prostate Cancer Metastatic to Bone  
Phase 2 – No Placebo

 
Basic Eligibility Criteria:
  1. Must be willing to undergo bone biopsy
  2. Must be willing to do MRI
  3. NO prior chemo
  4. Two WEEKS since any external radiation
  5. Two MONTHS since Xofigo, Samarium, or Strontium
  6. NO Coumadin, Heparin, or baby aspirin
For further screening and information, contact:

LOCATION:
Ann Arbor, MI
Dr. David Smith, University of Michigan

Contact:  Oncology nurse at U of M Cancer Answer Line - (800) 865-1125

 
Jan Manarite
Early/Expanded Access Committee
PCRI Senior Educational Facilitator

(239) 395-0995 Direct
The PROSTATE CANCER RESEARCH INSTITUTE is a registered non-profit organization. Visit us at
www.PCRI.org
I am a prostate cancer researcher and advocate, not a medical professional. Information I share with you is to help expand your knowledge for discussion with your own physicians
and should not be considered actual medical advice.

 


 
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