There is some good news on the horizon, or at least we are setting up for the possibility of some future good news. Coming off of the recent news about the very successful phase II trial of CB7630 (abiraterone acetate), Cougar Biotechnology, Inc. has reached agreement with the FDA under a special protocol assessment (SPA) for its planned phase III clinical trial foe men who are chemotherapy-naive, and castration-resistant.
The SPA which is a written agreement between the company and the FDA regarding the design, endpoints, and planned statistical analysis approach of the trial.
The trial will be a randomized, double-blind, placebo-controlled trial of abiraterone plus prednisone in patients who have not yet received chemotherapy.
The positive results from phase II clinical trials of abiraterone were recently presented at the Genitourinary Cancers Symposium in Orlando, FL.
I have written about abiraterone in prior posts, so you can search this blog for information.
If you qualify for this trial I would urge you to stay in touch with its progress as it gets up and running. I will try and keep you informed about it and how to make contact with the trial sponsors as the process becomes up and running.
Based on the phase II results that have been made available I do have hope that we will see positive results. We are in desperate need of additional tools to fight advanced prostate cancer and a new tool before chemo would be very welcomed.
Joel T Nowak MA, MSW
This is great news, although not so much for those you have already gone through one or more rounds of chemo. With success of this Phase III trial, perhaps the exclusions will change.
I believe the trial also excludes those who are chemo naive, but who have been treated with ketaconazole. Not such great news.
how can i connect with someone who is already on the abiraterone trial study or taking taxotere chemo , my husband has recurring prostate cancer.
I have been on Abiraterone for appx. one year now, and is working great! My numbers are down and holding, and my tumors are shrinking! I went to Taxotere chemo before I started on the trial.
Is anyone aware of a trial that is current recruiting and taking patients who have had chemo? My Dad was ineligible to go on the trial last year because he hadn’t had chemo and now we find he can’t receive abiraterone because he has had chemo.
His PSAs are now over 230 and rising with no other hormone drugs working so we have no other options left.
I have compiled a list of possible clinical trials that are currently recruiting for which your dad might qualify. If you go to http://www.clinicaltrials.gov and search for the trial number you can read about the trial, including inclusions and exclusions.
You should contact the trial director listed to get additional information as well as have any specific questions answered. Before deciding to join a trial you should discuss the trial with your doctor.
Ixabepilone, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy and Chemotherapy – NCT00331344
Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy – : NCT00895310
Study of Patupilone in Prostate Cancer Patients Who Progress After Hormone Therapy and Docetaxel Chemotherapy – NCT00407251
Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer – NCT00414388
Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy- NCT00974311
Sunitinib Plus Prednisone In Patients With Metastatic Hormone-Refractory Prostate Cancer After Failure Of Docetaxel Chemotherapy (SUN 1120) – : NCT00676650
Study Using IMC-A12 or IMC-1121B Plus Mitoxantrone and Prednisone in Metastatic Androgen-Independent Prostate Cancer, Following Disease Progression on Docetaxel-Based Chemotherapy – NCT00683475
Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy- NCT00627354
PHA-739358 for Treatment of Hormone Refractory Prostate Cancer – NCT00766324
Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel – NCT00499694
Sorafenib, Pemetrexed, and Cisplatin in Treating Patients With Advanced Solid Tumors – NCT00703638
Hoping all is well to everyone! I have been invited to take part in this trial, Abiraterone, phase 3. Metastases to the scapular, seems to be confined with a psa of 4.2 and testosterone level of 21. The lupron injections have started to fail after two years and recent CT scan looks good for radiation, 10 treatments. After that testing and trial will begin. We can only hope this test works so that others can begin to have some relief. I am going on 8 years and am very thankful for that. If anyone has any experience with this trial, it would be appreciated greatly to correspond. I will keep posting as well. Thanks.
Hope everything is going well with you.
I’m wondering if there is a possibility getting abiraterone for trial locally in Indonesia. We’re really hoping to get this drug as my father has HRPC with bone metastases. Already had spinal decompression surgery, now on 3rd chemo. Did I mentioned he is paraplegic after the surgery. He’s very weak condition. He is also a doctor and have access to major hospital here if we need to administer the treatment locally. Any help and info would mean a lot to us. Thanks.
I checked and unfortunately there are not any trials of abiraterone being run in Indonesia. They are mostly in the U.S. with one trial in British Columbia. Sorry – Joel
Thanks for your info.
I will try to request the Oncologist team back home to make a referral to Dr. De Bono at Royal Marsden Hostpital.
Do you have any insight when it will be commercially available to the market. At least keeping your hope high can be a good medication. Thanks again.