There has been a lot of news in the area of early access for great drugs to treat advanced prostate cancer prior to the FDA’s approval.

I have informed you about the Early Access Program for MDV-3100 in men with castrate resistant prostate cancer previously treated with a Docetaxel based chemotherapy agent. The latest news of this program is that there has been two (2) new sites added making it available in a total of 22 states.

The early access trial is designed to monitor the drugs safety. Nobody will receive a pacebo and the MDV-3100 will not have a cost to a participants. However, there might be some outside costs, so check with the site where you participate.

To participate in the trial the basic requiements are:
• CRPC/HRPC – on hormone therapy with progressive disease
• Metastatic
• 3 weeks since Zytiga (abiraterone)
• Previously treated with Taxotere (docetaxel)
• No small cell or neuroendocrine features
• No brain metastases
• No history of stroke or seizure
• No significant cardiovascular disease
• HGB 9.0 or higher

If you are interested in participating and you think you qualify contact one of the sites below for further screening.
Alaska Clinical Research Center, LLC
Contact: Robin Adams (907) 276-1455
Anchorage, Alaska 99508

Pinnacle Oncology/Hematology
Contact: Sherril Bierman (480) 278-8804
Scottsdale, AZ 85258

Prostate Oncology Specialists
Contact: Jennifer Leung (310) 827-7707
Marina del Rey, CA 90292

Dr Ronald Yanagihara
Contact: Katrina or Lara (408) 847-6194
Gilroy, CA 95020

Tower Urology/ Tower Research Institute
Contact: Maria Reyes (310) 854-9898 x160
Los Angeles, CA 90048

Stanford University Cancer Ctr
Contact: Denise Haas (650) 736-1252
Palo Alto, CA 94304
Ocala Oncology Center
Contact: Amy Liebman (352) 732-4938
Ocala, FL 34471

PeachTree Hematology Oncology Consultants
Contact: Ann Johnston (678) 298-3241
Atlanta, GA

Northwest Georgia Oncology Centers
Contact: Mary Gilley (770) 281-5131
Marietta, GA 30060
Illinois Cancer Care
Contact: Lori Lynch (309) 243-3627
Peoria, IL 61615

Investigative Clinical Research of Indiana LLC
Contact: Leslie Weitman (317) 716-0323
Indianapolis, IN 46260

Metairie Oncologist
Contact: Lucy Cousin (504) 885-0577 x 317
Metairie, LA 70006

Jackson Oncology Associates PLLC
Contact: Teresa Davis (601) 974-5547
Jackson, Mississippi 39202

Nebraska Hematology Oncology
Contact: Ashley Waldred (402) 484-4908
Lincoln, NE 68506

Comprehensive Cancer Centers of Nevada
Contact: Ann Lovelace (702) 952-3400 x 5414
Las Vegas, NV 89169

New Hampshire
New Hampshire Oncology Hematology PA
Contact: Margaret White (603) 224-2556 x 1323
Hooksett, New Hampshire, 03106

New York
Accumed Research Associates
Contact: Tammi Allegra (516) 746-2190
Garden City, New York, 11530

Associated Medical Professionals of New York
Contact: Tonya Godfrey (315) 706-8112
Syracuse, NY 13210

North Carolina
Cancer Centers of North Carolina
Contact: Julia Berry (919) 781-7070
Raleigh, North Carolina 27607

Tulsa Cancer Institute
Contact: Sharon Franklin (918) 292-8085
Tulsa, OK 74136

Tulsa Southwestern Regional Med Ctr
Contact: Jennifer Dvorak (918) 286-5448
Tulsa, OK 74133

Oregon Urology Institute
Contact: Stephanie Kerns (541) 284-5508
Eugene, OR 97477

University of Pennsylvania
Contact: Jenelle Robinson (215) 662-7398
Philadelphia, PA 19104

South Carolina
Charleston Hematology Oncology Associates, PA
Contact: Deborah McNeal (843) 266-2540
Charleston, South Carolina, 29414

Carolina Urologic Research Center
Contact: Tabitha Joyner (843) 449-1010 x228
Myrtle Beach, South Carolina, 29572
The Jones Clinic, PC
Contact: Morgan Medus (901) 685-5969 x322
Germantown, TN 38138

UT Southwestern Medical Ctr
Contact: Allison Beaver (214) 645-5921
Dallas, TX 75390

Virginia Oncology Associates
Contact: Wendi Gobhardt (757) 213-5813
Norfolk, VA, 23502

Northwest Medical Specialties
Contact: Linda Dheane (253) 302-2896
Tacoma, WA 98405

By the way, the new sites are located in Nebraska and Oregon.

The other news on the early access trial circuit is we now have been able to open early access trials for :
Radium-223 Chloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases
No placebo – No cost for Alpharadin (check with trial site for any other costs)

Basic Eligibility Criteria:
• CRPC/HRPC – on hormone therapy with progressive disease
• At least 2 bone metastases – blastic (sclerotic), not lytic
• Some amount of pain/bone pain (must be taking daily meds – even if it’s Tylenol)
• No mets to lung, liver, or brain
• HGB 10.0 or higher
• Previously treated with Taxotere (or have refused Taxotere – patient’s choice)
• 4 weeks since chemo, and No chemo currently planned
• No abiraterone (Zytiga) while on Alpharadin – previous OK
• No previous extensive radiation to bone (> 25% of bone marrow), and No previous Quadramet or Strontium 89

If you think you fit this Basic Eligibility Criteria, contact one of the sites below for further screening.

Goshen Cancer Center
Contact: Rebecca Eickoff (317) 716-0323 or
Goshen, IN 46526
Tulane University
Contact: Patrick Cotogno (504) 988-6542 or
New Orleans, LA 70112
Comprehensive Cancer Ctrs of Nevada
Contact: Victoria Le (574)364-2888 or
Las Vegas, NV 89169

* Enrollment Tip for both trials:
It often takes a few weeks to complete the enrollment and screening process for an expanded access trial. You may be able to speed up this process
by supplying the clinical trial nurse with your own medical records, which may relieve him/her from trying to obtain them from another clinic. Factor all of this into your decisions. As always, discuss with your physician(s).

I would like to thank Jan Manarite from PCRI for working on and keeping me informed about these Early Access Trials.

Joel T Nowak, M.A., M.S.W.