PSA velocity is a predictor of prostate cancer detection in men above age 60 as well as in younger men, according to findings presented at the annual meeting of the American Urological Association. William Catalona MD and colleagues presented evidence that PSA velocity “is significantly higher in men of all ages with prostate cancer compared to those without prostate cancer,” although the measure “performed the best in young men.” “Interestingly,” Catalona’s group writes, “the median PSAV in men with prostate cancer was less than 0.75 ng/ml/year regardless of age, suggesting that this threshold may be too high. Overall, this data confirms that PSA velocity is a useful tool for prostate cancer detection.”
Full story: PSA Velocity is a Signficiant Marker of Prostate Cancer in Older Men as Well as in Younger Men May 31, 2007

Novacea, Inc. (Nasdaq: NOVC) and Schering-Plough Corporation (NYSE: SGP) today announced that they have entered into an exclusive worldwide license agreement for the development and commercialization of Asentar (DN-101). Novacea is currently conducting a large international Phase 3 trial (ASCENT-2) evaluating Asentar in 900 patients with androgen-independent prostate cancer (AIPC). Asentar is a novel, proprietary, high-dose oral formulation of calcitriol, a potent hormone that exerts its effects through the vitamin D receptor (VDR). Full story:
Novacea and Schering-Plough Enter Into Worldwide Development and Commercialization Agreement for Asentar, a Novel Treatment for Prostate Cancer

A single PSA measurement in middle age can predict diagnosis of advanced prostate cancer up to 25 years later in an unscreened population, according to research presented at the annual meeting of the American Urological Association (AUA).

Almost all advanced cancers could be found early by intense screening of at-risk patients, according to researchers from New York and Malmo, Sweden who analyzed samples taken from a population-based cohort of 21,277 men in Malmo, Sweden between 1974 and 1986 to determine whether initial PSA plasma levels correlated with future diagnosis of advanced disease.

Of the 21,277 cases, 498 men actually developed prostate cancer, and 161 suffered from advanced disease (greater than T3 or metastasis). Association between PSA levels and eventual development advanced disease was determined using conditional logistical regression. In men with a total PSA of .5, .75, 1., 1.5 and 2 ng/ml, the probability of being diagnosed with advanced disease by age 75 was 2 percent, 3 percent, 4 percent, 7 percent and 12 percent, respectively. Risk was highly concentrated, with 89 percent of advanced cancers occurring in men with the top 10 percent of PSA levels.

This finding was presented Moderated Poster Session 59 at AUA on Wednesday, May 23 , 2007.

Jim Kiefert, chair of the executive committee of US Too International prostate cancer support group, interviewed yesterday at the American Urological Association (AUA)’s annual meeting by CNBC’s pharmaceuticals reporter Mike Huckman, said some members of his support group wept when they heard FDA had delayed approval of Dendreon’s vaccine for advanced prostate cancer, Provenge. The interview with Kiefert is part of the video at this CNBC link. Meanwhile advocates are signing a petition and plan to demonstrate in Washington D.C. and hope to meet with the head of the FDA.

Lack of cancer education, writes Aria White, NNPA Special Correspondent, causes desperate deaths for African-Americans. Because of a lack of education on cancer and cancer-prevention in the African-American community, African-Americans are more likely than any other race or ethnicity to die from cancer, according to medical experts, White reports.

”The problem is that we don’t do enough of what works,” says Sanya Springfield, Ph.D., Director of the Center to Reduce Cancer Health Disparities, in an interview.

According to the National Cancer Institute (NCI), African-American men are 35 percent more likely to die from cancer than White men and African-American women are 18 percent more likely to die from cancer than White women.

Cancer death disparities are top priority at the National Cancer Institute. The NCI’s Center to Reduce Cancer Health Disparities tries to determine the cause for such health disparities in minorities.

”The difficulty lies in funding, there are plenty of models out there that work, there just aren’t enough of them,” Springfield says.

FoxNews (“Fair and Balanced”) aired Killer Bureaucracy: Why the FDA is Keeping Lifesaving Drugs from Cancer Patients May 19, 2007. Paul Gigot interviewed Dr. Scott Gottlieb. Scott Gottlieb MD, a stock analyst appointed to a top FDA job by President Bush in 2005, returned to Wall Street where he promotes Dendreon’s Provenge in his Forbes/Gottlieb Medical Technology Investor newsletter.

Timing of Androgen Deprivation Therapy and its Impact on Cancer-specific Survival after Radical Prostatectomy: A Matched-cohort Analysis (Abstract 601)

Adjuvant androgen deprivation therapy (ADT) can improve survival following radiation therapy or radical prostatectomy. Researchers from the Mayo Clinic in Rochester, Minnesota conducted a study that focused on 6,401 patients who underwent radical prostatectomy between 1990 and 1999 with node-negative prostate cancer. Patients were divided into five groups: those who underwent ADT in the adjuvant setting; those with ADT initiated at PSA greater or equal to 0.4 ng/ml, ADT initiated at PSA greater or equal to 1 ng/ml. ADT initiated at PSA greater or equal to 2 ng/ml and ADT at systemic progression. Median follow-up for the cohort was 10 years.

The study found that patients who underwent adjuvant ADT experienced improved 10-year systematic progression-free survival (95 percent vs. 90 percent) and 10-year cancer-specific survival (98 percent vs. 95 percent) compared to patients who did not undergo adjuvant ADT. The results do not dictate whether the initiation of ADT at any other stage can impact survival, although the survival advantage was found to diminish if ADT is administered farther in the disease process. These findings do, however, support the immediate use of ADT in high-risk radical prostatectomy patients while suggesting the limitations of ADT in enhancing survival after prostate-specific antigen progression.

This abstract will be presented during Podium Session 20 on Sunday, May 20 2007 starting at 3:30 p.m.

The Food and Drug Administration (FDA) is advising consumers not to purchase or use “True Man” or “Energy Max” products promoted and sold as dietary supplements throughout the United States. Both products — touted as sexual enhancement products and as treatments for erectile dysfunction (ED) — contain potentially harmful, undeclared ingredients.The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.

The undeclared analog ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Seattle P-I reporter DAN RICHMAN in an article updated tonight writes:

Seattle-based Dendreon Corp. will delay releasing its much-anticipated Provenge drug to fight prostate cancer until at least next year and possibly until 2010, spokeswomen said Thursday.

Because of that delay, the company Thursday cut 15 percent of its 250-person work force, laying off the roughly 40 staffers who were preparing to begin marketing Provenge later this year, said one spokeswoman, Monique Greer, in an interview Thursday morning.

The Food and Drug Administration last week unexpectedly declined to approve Provenge, Dendreon’s only product, without more data supporting the drug’s effectiveness.

“We expect interim data in 2008, but it’s event-driven, by deaths or survival, so it could be 2010 until we have final-survival analysis,” Greer said in an interview Thursday morning. The drug will make it to the market “at the earliest in 2009, potentially,” she said.

She said the company plans to meet with the FDA in the near future and will base its next steps on the results of that meeting.

Full Story Seattled PI, Dendreon will Delay Provenge…

A site to advocate for “Provenge Now!” has been launched. Provenge is Dendreon’s immunotherapy for prostate cancer, which was approved 17-0 for safety and 13-4 for efficacy by an FDA Advisory Committee vote March 29th this year. On May 9, Dendreon announced that FDA has sent them a “Complete Response Letter,” commonly called an approvable letter, requesting more data. Dendreon CEO Mitchell Gold said “The FDA has requested additional clinical data in support of the efficacy claim.”