Gland of Opportunity

Dr. William J. Catalona built an unrivaled repository of blood and tissue samples. Washington University wants to keep it. Now a judge will decide: Who owns the prostates?

Almost immediately, PSA tests became de rigueur for men who are at risk for prostate cancer. Celebrities who survived cancer, including Dole, former financier Michael Milken and General Norman Schwarzkopf, touted PSA tests in television, newspaper and magazine interviews and credited blood tests for saving their lives. Less fortunate victims, including rock musician Frank Zappa, LSD guru Timothy Leary and actor Telly Savalas, succumbed.

In short, the prostate gland, an organ that was once taboo, came out of the closet. It was OK for a former presidential candidate to talk about his prostate while endorsing Viagra, a drug that can help reverse post-operative impotence. Research money skyrocketed, both in the private and public sector. In 1992 the federal government spent $31.4 million on prostate-cancer research. By 2002 the amount had zoomed to $278.4 million. Milken, who became as zealous a philanthropist as he was a financier, established the Association for the Cure of Cancer of the Prostate (CaP CURE), a private foundation that has raised more than $100 million for prostate-cancer re-search since 1994 and distributed it on a streamlined basis to scientists who once had to wait months or years for government funding.

Catalona became a darling of the mainstream press, with interviews in the New York Times, the Wall Street Journal, USA Todayand other publications. His research had mushroomed in 1991, when he began enrolling St. Louis-area men in a long-term study designed to fine-tune PSA testing and further prove its efficacy. Over time, about 36,000 men enrolled in the study and received regular PSA tests. Based on mass screenings supervised by Catalona, the Food and Drug Administration in 1998 approved a new form of the PSA test manufactured by Hybritech, a San Diego biotech company that helped fund the doctor's work. (The test is not without its critics. For more, see accompanying sidebar.)

In 1983, Catalona claims, he started saving blood and tissue from patients to help investigate the causes of prostate cancer and potential treatments. Eventually the doctor expanded the collection to include specimens from relatives of prostate-cancer patients that could prove instrumental in determining the disease's genetics and finding a cure.

Although more than 200,000 men are diagnosed with prostate cancer annually in the United States and about 30,000 die each year, collections of research-quality tumor tissues are as rare as Rembrandts. Approximately 10,000 men have donated samples now stored at Washington University. Besides being big, the collection preserved at minus 70 degrees Fahrenheit may be the oldest in existence. As such, it is coveted by researchers looking for telltale markers of prostate cancer on chromosomes or proteins within the bloodstream.

Dr. Gerald Andriole, head of urology at Washington University's medical school, says the frozen tumor tissue and blood may one day help patients decide whether they should undergo surgery, radiation or any treatment at all, given that prostate cancer often poses no risk to a man's life because many tumors have slow growth rates.

"Right now, based on what we know about prostate cancer, it's literally a coin toss: You could choose surgery or you could choose radiation," Andriole says. By analyzing samples from the repository, researchers may be able to determine that men with certain markers were cured by radiation that didn't work for patients who had different markers. "It could be a genetic marker on a chromosome, it could be a cell-surface marker, which is usually a protein, it could be combinations of different types of markers," Andriole says. "If we knew that all the men who had x, y, z [markers] responded well to radiation, then you could say, 'If my tumor is x, y, z, I want to have radiation.' Some men are destined never to die of prostate cancer. Wouldn't it be terrific if we could call you up and say, 'Gee, you have prostate cancer, but guess what? We've done these marker studies and guys who have the marker profile that you have, they almost never die of prostate cancer.'"

Catalona and Andriole, who wants the tissue bank to remain at Washington University, agree on at least one thing: The stash is special.

"The repository is unlike any other repository, in the sense that it's been collected over a long period of time, so people can go back now and look at these tissue samples and see if the markers are present," says Gregory Piche, Catalona's attorney. But the specimens don't last forever, the lawyer notes: "These samples are not stable. When you use them [for research], you consume them."

That's one reason the university wants to guard them, Andriole says. "Some of this material -- the tissue, the DNA, for example -- you use it once, adios amigos: It's lost," he explains. "You don't want to let somebody with some half-baked, not completely thought-through concept just use your repository."

The value and rarity of the repository is reflected in how much CaP CURE has spent to build up the nation's stock of prostate tissue. After Milken founded the group nine years ago, one of his first steps was donating money to collect and maintain specimens at three universities, including Washington University, which received $500,000. According to a 1999 article in the journal Science, the private foundation was doling out $800,000 a year to support the banks.

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