Health Diaries > Prostate Cancer > The Prostate Cancer Blog

October 12, 2007

Prostate Cancer Clinical Trials in Dallas, Texas Area

Filed under: Research

My name is Barry Mirtsching, MD. I have directed a clinical research program here at Medical City Dallas Hospital for about 10 years. We now have about 60 studies for various malignancies that are active at the Center for Oncology Research & Treatment. We have expanded to a second location in Plano, TX, for patients who live farther to the North.

I believe we have the most comprehensive program of clinical studies for prostate cancer in the Dallas area. We attempt to have multiple options open for our prostate cancer patients, so they can sequentially have access to a series of therapies. I believe that has tremendously improved survival and disease control in the hormone-refractory patient group of patients that we see.

Our current trials for prostate cancer include (with brief descriptions of the studies and risks):

G-VAX Vaccine Study for Hormone-Refractory Prostate Cancer
G-VAX is a cellular vaccine against prostate cancer. Initial studies have demonstrated activity of G-VAX in prostate cancer patients who have failed hormone treatments (hormone refractory prostate cancer, HRPC). Two national studies of G-VAX for HRPC have been conducted at CORT. The first, VITAL-1, is no longer enrolling patients. This study tested the G-VAX therapy against standard therapy with docetaxel (Taxotere) and prednisone in patients who do not have bone pain related to metastatic disease. The second study, VITAL-2, is continuing at CORT, enrolling patients who have active bone pain related to their metastatic disease. This study tests standard therapy with Taxotere and prednisone with or without the G-VAX vaccine. All patients do receive standard therapy.

The risks of chemotherapy for HRPC in this study are fatigue, nausea, vomiting, muscle or bone aches, sensory neuropathy, fever, allergic reaction, or low blood counts. These risks are those of standard treatment. The risk of G-VAX is injection site swelling and discomfort.

DN-101 (Ascentar) for Hormone-Refractory Prostate Cancer
DN-101 (Ascentar) is a high-dose formulation of the active form of vitamin D. Vitamin D, once thought of as only a hormone that regulates calcium metabolism, is now known to be an important growth regulator in many types of tissues, by its action on vitamin D receptors. Activation of vitamin D receptors slows or stops cell division, and promotes differentiation of cells, the process of cells taking on normal functions. In an initial phase II study, addition of DN-101 to standard chemotherapy with docetaxel (Taxotere) and prednisone has been shown to increase response to treatment and prolong disease control in patients with hormone-refractory prostate cancer (HRPC). CORT is conducting a phase III study of standard Taxotere and prednisone therapy with or without Ascentar for the first-line treatment of HRPC. All patients do receive standard therapy.

The risks of chemotherapy for HRPC in this study are fatigue, nausea, vomiting, muscle or bone aches, sensory neuropathy, fever, allergic reaction, or low blood counts. These risks are those of standard treatment. The risk of G-VAX is injection site swelling and discomfort.

XRP6258 for Hormone-Refractory Prostate Cancer
XRP6258 is a novel taxane that has been shown to be active in patients with hormone refractory prostate cancer (HRPC) who have failed or progressed after prior therapy with docetaxel (Taxotere) and prednisone, the standard first-line treatment for HRPC. CORT is conducting a study of XRP6258 plus prednisone versus standard mitoxantrone (Novantrone) and prednisone in HRPC patients who have failed prior Taxotere therapy.

The risks of XRP6258 are sensory neuropathy, fatigue, nausea, vomiting, low blood counts, fever, infection, allergic reaction, or hair loss. The risks of standard mitoxantrone therapy are fatigue, hair loss, low blood counts, fever, infection, mouth ulcers, or cardiac dysfunction.

Satraplatin for Hormone-Refractory Prostate Cancer
Satraplatin is a platinum chemotherapy compound that can be administered orally. It appears to have minimal risk of neuropathy or kidney injury. Phase III studies have demonstrated that Satraplatin is more active that prednisone alone for patients with advanced HRPC who have already failed existing standard therapies. Satraplatin is pending approval by the FDA. It is currently available only within a study program. CORT is please to offer access to Satraplatin through the Expanded Access Study. All patients who qualify will receive Satraplatin. The risks of Satraplatin include nausea, vomiting, fatigue, diarrhea, and low blood counts.

Combining Chemotherapy with Initial Hormone Therapy for Metastatic Prostate Cancer
Androgen ablation hormonal therapy (castration or LHRH drugs to reduce androgen levels) are the standard initial management for metastatic prostate cancer patients, as most have hormonally sensitive disease. Patients with high risk features (more extensive boney metastatic disease, high Gleason histologic scores) might benefit from the initial addition of chemotherapy to hormonal treatment.

CORT is participating in the national ECOG 3805 study called the CHAARTED (ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease), which moves docetaxel (Taxotere) chemotherapy earlier into the hormone-sensitive phase of metastatic prostate cancer treatment. Patients with poorer risk, higher PSA levels and higher alkaline phosphatase (bone enzyme) levels with bone pain are randomly assigned to treatment with hormones versus hormones with Taxotere chemotherapy. The goal of the study is to determine if the addition of docetaxel to standard androgen ablation therapy improves remission duration and survival, when compared to androgen deprivation therapy alone.

The side effects most frequently experienced with Taxotere include fatigue, nausea, vomiting, diarrhea, fever, infection, sensory neuropathy, low blood counts, and fever. Standard androgen ablation hormonal therapy may produce fatigue, hot flashes, impotence, increased risk of thrombosis, or loss of libido.

Combination Chemotherapy for Hormone-Refractory Prostate Cancer Failing Initial Therapies
The regimens of ketoconazole, doxorubicin (Adriamycin), vinblastine (Velban), and estramustine (KAVE) or estramustine and vinblastine (EV) are active in patients with hormone refractory prostate cancer (HRPC) who have progressed following docetaxel (Taxotere) chemotherapy. CORT is participating in the multicenter MDA-3410 study, which tests the KAVE therapy or the EV regimen, followed by weekly doxorubicin for six weeks in HRPC. Patients who complete therapy are then randomly assigned to therapy with a radioactive isotope, Strontium-89 (Sr-89, which is FDA-approved for treatment of metastatic prostate cancer). The goal of the study is to measure the response rate, remission duration, and tolerance of patients to this treatment.

Risks of these treatments include hair loss, fatigue, nausea, vomiting, diarrhea, thrombosis, low blood counts, fever, sensory neuropathy, deficiency of adrenal hormones, and cardiac dysfunction.

For more information on our research studies, visit www.CORTPA.com, or speak with a Study Coordinator at 972-566-5588.

The CORT blog is located at http://cancernews.wordpress.com. The prostate studies are also located there.

Barry C. Mirtsching, MD
Clinical Director
Center for Oncology Research & Treatment, PA
Dallas, TX
bmirtsching@cortpa.com

Office Locations:
Medical City Dallas Office: 7777 Forest Lane, Suite B-242, Dallas, TX 972-566-5588

Presbyterian Hospital of Plano Office: 6124 W. Parker Rd., Suite 532, Plano, TX 75093 972-981-4012

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A true story from a cancer patient

My name is Jacqui Hunt. In 2001 I was diagnosed with B cell non-Hodgkins Lymphoma, or lymphatic cancer.

I was told that there was no effective treatment for my condition and all that modern medicine could provide was to monitor the progress of the cancer and give chemotherapy to reduce symptoms when they became more severe. Chemotherapy could bring about temporary reduction in the condition but the cancer would inevitably return and the second time it would probably be much more aggressive.

After the initial shock of the diagnosis and a period of considerable fear, I set about dealing with the cancer in my own way using any type of alternative or integrative therapy that I thought might help.

Despite all my efforts the cancer did progress and by the middle of 2004 I had developed a tumour in my stomach measuring 13cm x 8cm x 4cm. It was palpable and measured by ultra sound scan. My stomach protruded as if I was 6 months pregnant and I could feel a strong pulse in my stomach over the tumour.

It was at this time that I was introduced to the Chinese herbs Agrimseng. The acupuncturist who was treating me had visited a cancer hospital in China and had learned of a combination of Chinese herbs that had been developed specifically to treat cancer. He asked me if I would be willing to try the herbs Agrimseng and I agreed, as I felt I had nothing to loose and much to gain. I was convinced the herbs were well researched and were completely safe with a great deal of ancient Chinese herbal knowledge behind them. As the herbs were gifted to me, part of the agreement to use them was that I would have ultra sound scans each six months to track the progress of the tumour.

By the end of 2004 at the same time that I started taking the herb Agrimseng I also began my training to become a qualified Mindbody Psychotherapist in Core Energetics, Australia.

Over the next few months I started to feel better. My energy levels increased and I somehow felt more positive in myself. My stomach began to feel more settled and seemed not to protrude quite as much. They were subtle changes. The scans were not showing much at first, although the depth of the tumour didn’t seem to be so easy to pick up and the radiologists stopped reporting that particular measurement.

One radiologist, who knew I had had no traditional treatment, became concerned when she couldn’t find a tumour of the size previously recorded. She thought she had made a mistake. But I already knew by this time that the tumour was reducing.

In the final session with the Oncologist in May 2006 he could find no palpable tumour, my stomach had returned to normal size and I was feeling very well. My spleen size which had been significantly increased had also returned to normal.

By June 2007, six years after diagnosis and at a time when the cancer would be expected to be spreading there is no sign of the tumour and I am fit and healthy. I believe that my return to good health was brought about by the use of the Agrimseng Herbs combined with extensive psychotherapy, in particular Mindbody psychotherapy, Both the Agrimseng herbs and the Mindbody psychotherapy work with the emotional body, and I believe it is at this level that we need to truly heal ourselves.

Jacqui Hunt

For more information, please go to: www.ahrc.co.nz or ph: 0064 9 4788968

One of the leading technologies is HIFU and should also be looked into. Currently available in other countries while clinicals take place in the states.



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