Prostate Cancer

Clinical Trials

Below is a list of Prostate Cancer clinical trials from the clinical trials database at Mayo Clinic.

This list includes only trials about which Mayo researchers choose to publish information. Mayo Clinic may be conducting other trials which are not in this database. Mayo's clinical trials include experimental treatments, often unavailable elsewhere, which frequently lead to improved patient care for people worldwide. Patients should ask their doctor at Mayo about clinical trials appropriate for their situation.

A Phase 2 Study of E7389 (Halichondrin B Analog) to Treat Patients Diagnosed with Prostate Cancer which has spread (Metastatic) and is Resistant to Hormonal Therapy
The purpose of this study is to find out the effects, good and bad, E7389 (Halichondrin B analog) has on a patient and their prostate cancer. E7389 (Halichondrin B analog) is an investigational drug. It has not yet been approved by the U.S. Food and Drug Administration (FDA) for use in treating prostate cancer.
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A Phase 3 Study of Docetaxel (Taxotere) in Combination with CG1940 and CG8711 versus Docetaxel and Prednisone in Taxane-Naive Patients with Metastatic Hormone-Refractory Prostate Cancer with Pain
This study is being done to:
- Study the effects (good and bad) of docetaxel in combination with CG1940/CG8711 versus docetaxel and Prednisone will have on a patient, their pain level, and their metastatic prostate cancer
- Compare the effectiveness of docetaxel in combination with CG1940/CG8711 versus docetaxel and prednisone alone

CG1940 and CG8711 are two parts of an investigational product that is made from prostate cancer cells. The prostate cancer cells used to make this CG1940/CG8711 have been changed so that they release something called GM-CSF (granulocyte-macrophage
colony-stimulating factor) to help make the immune system work against cancer. GMCSF is something made by a patient's body that increases the amount of certain white blood cells and makes them more active.
To make the CG1940/CG8711, the gene for GM-CSF was put into the prostate cancer cells using an artificial virus that has parts of a virus called Adeno-Associated Virus. The cells were then treated with radiation so they cannot grow or divide after they are injected under the skin. The cells themselves are not radioactive. Because a gene was put into the cells this is a form of gene therapy, which is experimental, and is not approved by the US Food and Drug Administration (FDA) unless patients are receiving it as part of a research study such as this one.

Docetaxel is an anti-cancer drug that has been approved by the FDA to treat different types of cancer including prostate cancer. Docetaxel is the common name for the commercial drug Taxotere. Prednisone is a type of drug called a steroid that is used in many different types of disease to reduce inflammation. It is used in prostate cancer treatment to ease symptoms such as pain.

Previous studies with CG1940/CG8711 alone have shown that it is generally well tolerated. In these studies it was observed that PSA (Prostate Specific Antigen) levels could continue to rise during the first few months of immunotherapy. It was also observed that for some patients the PSA level dropped or stabilized after it has initially risen. A possible explanation for this delayed drop in PSA is that it takes time for the body to develop an immune response against the cancer cells.
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CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
This study is being done to:
See if giving docetaxel chemotherapy, at the time a patient is starting hormonal therapy (treatments to lower testosterone) is more helpful than giving it only at the time the hormonal therapy is no longer working.

Hormonal therapy refers to drugs or surgical procedures such as an orchiectomy (removal of testicles) used to lower a patient's testosterone. This puts prostate cancer into remission (cancer has completely or partially gone away) in most patients as testosterone can worsen the cancer. It is the standard treatment for prostate cancer. Normally chemotherapy is reserved for when a patient's cancer starts to grow again despite having a low testosterone level. In this study the patient will either get a chemo therapy drug docetaxel when they start hormonal therapy or when/if their cancer grows with a low testosterone level. If a patient is to have chemotherapy when starting hormones for the first time, they may get chemotherapy when/if their cancer grows back with a low testosterone level.

This protocol is suggesting that a patient's doctor use docetaxel (a type of chemotherapy) if the patient's disease gets worse, even if they had received docetaxel when they started hormone therapy. A patient's doctor may try another hormone treatment before starting them on docetaxel chemotherapy. The reason for this study is to see if getting docetaxel when a patient starts hormone therapy (or within 90 days of starting hormonal therapy) and again, if their disease gets worse, is better than getting docetaxel only at the time the patient's disease gets worse. This study will tell us which way is more effective in treating a patient's disease.
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Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer (MC0253)
This research study is being done to compare the effects of conventional hormone therapy alone versus conventional hormone therapy with an investigational medicine (MDX-010) in the treatment of advanced prostate cancer.
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Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy with Brachytherapy Alone for Selected Patients with Prostate Cancer (0232)
This research study is being done to:

• Compare the effects (good and bad) of two different radiation treatments in patients with prostate cancer. The effects of placing small radioactive seeds inside your prostate (brachytherapy) after external radiation therapy will be compared to the effects of using brachytherapy alone in patients with prostate cancer.
• See which treatment is better.
• Look at your biopsied prostate cancer tissue for information that may help predict and treat prostate cancer in the future.
• Gather information about the effects of the treatment on your quality of life.
• Compare the cost between the two treatments, including long term costs, for patients under Medicare.

Phase III Study with Radiation Therapy (Hypofractionated 3D-CRT/IMRT Versus Conventionally Fractionated 3D-CRT/IMRT) in Patients Diagnosed with Locally Advanced (Stage 2) Prostate Cancer
One of the standard treatment options for locally advanced prostate cancer is external beam radiation therapy. More recent radiation planning methods with three dimensional therapy or intensity modulated radiation therapy (IMRT) allow safer delivery of higher than conventional daily doses of radiation.

This study is being done to compare the effects (good and bad) on the patient and their cancer of the standard dose of radiation therapy (41 treatments over eight weeks) with a higher daily dose (experimental) of radiation (28 treatments over five and a half weeks) to see if the effects of the treatments are similar.
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RTOG (Radiation Treatment Oncology Group) 0526, Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Cancer following External Beam Radiotherapy
The purpose of this study is to evaluate the safety and effectiveness of brachytherapy (radiation seed implants) as treatment for prostate cancer that has come back in the prostate after external radiotherapy. The study will look at the side effects of the implants as well as the ability of the implants to get rid of the cancer.

It is important for the patient to realize that sometimes when prostate cancer comes back in the prostate after radiation, it may be very slow growing and may not cause symptoms or problems for years. Sometimes just monitoring the patient's condition and not undergoing treatment is appropriate.
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SPORE in Prostate Cancer
This research study is being done to collect regular and routine follow-up information related to the outcome of treatment for prostate cancer.

This study is also being done to relate treatment outcome to measurement of substances in the blood such as PSA and other markers. Also environmental and genetic factors that might be responsible for prostate cancer are being investigated.
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Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone (90202)
This research study is being done to compare the effects (good and bad) of early treatment with zoledronic acid (Zometa) compared to standard treatment with zoledronic acid.
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