New prostate cancer treatment: what's here, what's coming

This page provides brief summaries about new prostate cancer treatment that is either available now—or is in development. It will be updated regularly, so check back to find out what’s being touted as the latest treatment on prostate cancer blogs, drug and device manufacturer web sites, government, and other institutional web sites. Also check our News You Can Use section.

February 1, 2012: A new radiopharmaceutical (I-131-MIP-1466) that is designed to deliver a therapeutic dose of radiation directly to metastatic prostate cancer, is expected to tested in clinical trials in early 2013. It will be the first trial of a small-molecule-based radiopharmaceutical specifically targeting prostate-specific membrane antigen (PSMA), a type of protein expressed in high levels on prostate tumors.

January 31, 2012: Scientists at Trinity College have developed a new vaccine to treat cancer at the pre-clinical level. This new approach is based on manipulating the immune response to malignant tumors. The next step is to develop the vaccine for clinical use.

January 31, 2012: Dutasteride, which is commonly used to treat prostate enlargement, may also reduce the need for treatments that pose risks of incontinence and impotence — and delay growth of early-stage prostate cancer — according to a study published online first in The Lancet.

January 25, 2012: Researchers from Massachusetts Institute of Technology (MIT) and Massachusetts General Hospital have created a new drug delivery system that delivers chemotherapeutic drugs to prostate cancer cells.

September 15, 2011: Oncothyreon Inc. announced enrollment of the first patient in a Phase 2 trial of PX-866 in men with recurrent or metastatic castration-resistant prostate cancer. PX-866 is a small molecule compound designed to inhibit the activity of phosphatidylinositol-3-kinase (PI-3K), a component of an important cell survival signaling pathway.

September 15, 2011: German scientists are developing a microchip sensor that can be implanted near a prostate cancer tumor to monitor its growth aggressiveness, by sensing when oxygen levels in surrounding tissue drop.

September 13, 2011: ZYTIGA® (abiraterone acetate), a new, once-daily, oral androgen biosynthesis inhibitor has been approved for use by the European Commission.

August 25, 2011: The FDA has granted Fast Track designation for the investigational drug Alpharadin (radium-223 chloride) for the treatment of castration-resistant prostate cancer in patients whose cancer has spread to the bone (bone metastasis).

July 26, 2011: Janssen-Cilag International NV has announced that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of ZYTIGA® (abiraterone acetate) under an accelerated regulatory review procedure. ZYTIGA is a once-daily, oral, androgen biosynthesis inhibitor developed for the treatment of prostate cancer.

June 23, 2011: Investigators at the Mayo Clinic, with collaborators in the United Kingdom, say they have cured prostate tumors in mice with an experimental human vaccine that had no apparent side effects.

June 7, 2011: OncoGenex Pharmaceuticals, Inc. announces new data showing how its lead investigational compound, custirsen (OGX-011/TV-1011), may work with innovative therapies MDV3100 and heat-shock protein 90 (Hsp90) inhibitors to suppress prostate cancer cell survival and improve treatment outcomes.

May 2, 2011: The FDA has approved abiraterone acetate (Zytiga) for treatment of late-stage, castration-resistant prostate cancer as a combination therapy with prednisone in patients who have received prior chemotherapy with docetaxel.

April 19, 2011: BioSante Pharmaceuticals, Inc. announced that it has licensed its prostate cancer vaccine to Aduro BioTech, a clinical-stage immunotherapy company, solely for use in combination with Aduro's proprietary vaccine platform based on Listeria monocytogenes (Lm).

February 15, 2011: The nation's first FDA-approved cancer treatment vaccine, Provenge (sipuleucel-T), is being offered for the first time in Western New York at Roswell Park Cancer Institute.

February 3, 2011: The FDA reports it will not approve an indication for the benign prostatic hyperplasia (BPH) drug dutasteride (Avodart) for use in prostate cancer prevention. GlaxoSmithKline applied to have the drug approved for use in patients with high prostate-specific antigen levels, but who did not have prostate cancer in a biopsy.

December 9, 2010: An FDA advisory panel has voted overwhelmingly that GlaxoSmithKline's dutasteride (Avodart) and Merck's finasteride (Proscar) should not be used to prevent prostate cancer because the drugs are linked to a higher incidence of high-grade tumors.

October 5, 2010: Two new treatments for castration-resistant prostate cancer have been approved the the FDA. Sipuleucel-T (brand name Provenge; from Dendreon) is the first immunotherapy approved for treatment of prostate cancer. Cabazitaxel (brand name Jevtana; from Sanofi-Aventis) is approved for second-line treatment of metastatic castration-resistant prostate cancer in men who were previously treated with the chemotherapy drug docetaxel (brand name Taxotere; from Sanofi-Aventis).

August 16, 2010: BioProtect's SpaceGuard Balloon is a new device for men with prostate cancer who are undergoing radiotherapy treatments. This implant separates the prostate from healthy tissues and organs surrounding the prostate to minimize the radiation that is delivered to these organs. The implant then dissolves after 3-6 months. A multi-center clinical trial is underway in the US, Europe and Israel.

August 11, 2010: Augmenix, Inc. announces the first commercial implantation of the company's SpaceOAR System. The SpaceOAR hydrogel (from spacing Organs At Risk) is designed to be a tissue compatible, absorbable spacer to reduce radiation injury to healthy tissues.

April 29, 2010: Dendreon Corporation announced that the U.S. Food and Drug Administration has approved their drug Provenge (sipuleucel-T) for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer.

February 17, 2010: A very small clinical study (29 men) conducted by researchers at Queen's University suggests that a very low dose of nitroglycerin may slow and even halt the progression of prostate cancer. While larger studies are needed, this is a very interesting new prostate cancer treatment.

November 25, 2009: GlaxoSmithKline announced that it is withdrawing its US Supplemental New Drug Application for Avodart (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease. The company expects to resubmit the file soon and they state that their action was not the result of new findings related to safety or efficacy.

November 13, 2009: Debiopharm and Ipsen have confirmed French regulatory clearance for a six-month sustained-release formulation of Decapeptyl, a LHRH agonist and new prostate cancer treatment for both locally advanced and metastatic prostate cancer. It is expected that Ipsen will launch the drug in France in the first quarter of 2010.

October 20, 2009: Satraplatin is an orally administered platinum-derived chemotherapy agent from Spectrum Pharmaceuticals, Inc., which is being studied for use in men with advanced, hormone-refractory prostate cancer.

June 24, 2009: The Mayo Clinic reports that two men who had advanced and inoperable prostate cancer have made remarkable recoveries following combination treatment with hormone therapy and an experimental immunotherapy drug called ipilimumab. Both men had their tumors shrink and their PSAs drop to levels where they were able to have surgery. Further research on this potential new prostate cancer treatment is planned.

May 26, 2009: UCLA urologists have opened enrollment for the West Coast site of a national study using high-intensity focused ultrasound (HIFU) to treat prostate cancer recurrence following radiation therapy. Several thousand HIFU procedures have been performed in other countries, but the treatment is currently considered to be investigational in the United States.

May 25, 2009: Researchers at the Center for Holistic Urology at Columbia University Medical Center and New York-Presbyterian Hospital/Columbia are investigating a novel herb-based therapeutic called Zyflamend. They suggest that Zyflamend provides an anti-inflammatory mechanism of action to decrease prostate cancer proliferation in cell testing.

April 14, 2009: Dendreon Corporation announced today that the pivotal Phase 3 IMPACT study of the new prostate cancer treatment PROVENGE® (sipuleucel-T) met its primary endpoint of improving overall survival in men with advanced prostate cancer, compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design. The safety profile of PROVENGE (which is still an investigational treatment) appeared to be consistent with prior trials.

April 9, 2009: Howard Hughes Medical Institute reports that a new therapy for metastatic prostate cancer has shown promise in early clinical trials with men whose disease has become resistant to current drugs. The drugs are second-generation antiandrogen therapies that prevent male hormones from stimulating growth of prostate cancer cells. In a phase I/II safety trial, 22 of 30 men who received low doses of one the drugs had a sustained decline in their PSA level. Larger phase III clinical trials are planned to evaluate this new prostate cancer treatment, including its effect on survival in men with metastatic cancer.

March 23, 2009: The Cancer Institute of New Jersey is testing whether using an arthritis pain drug (Celebrex®) and a cholesterol-lowering drug (Lipitor®) together hold any promise in slowing or stopping the growth of prostate cancer when they are combined.

March 11, 2009: Sicel Technologies, Inc. has received clearance from the FDA to begin marketing DVS®-HFT, a new version of the company's DVS (Dose Verification System), a wireless implantable dosimeter that measures the actual radiation dose at the tumor site as men with prostate cancer are undergoing external beam radiation therapy.

March 4, 2009: Ferring Pharmaceuticals USA announced the commercial availability of degarelix for injection (the trade name is pending). Degarelix is a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist that has been approved by the FDA for the treatment of hormone sensitive advanced prostate cancer. This new prostate cancer treatment is available for order through traditional and specialty pharmacy distributors, as reported on PR Newswire.

March 1, 2009: Positive preliminary results have been reported from a Phase II study of AT-101 in combination with docetaxel and prednisone in men with docetaxel refractory, castrate resistant prostate cancer. AT-101, is Ascenta Therapeutics’ oral, pan-Bcl-2 inhibitor. In this study, fourteen of 37 men treated had at least a 30 percent decrease in PSA level and seven men achieved a confirmed partial response (defined as a PSA decline of 50 percent or greater).

January 21, 2009: Researchers assessing both preclinical (in vitro and and in vivo data) and clinical trials on the effect of phytochemicals (plant-derived compounds), including genistein, lycopene, epigallocatechin gallate, resveratrol, and mistletoe, have determined that these substances have no therapeutic use to prevent tumor progression or extend survival.

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