Watchful Waiting Prostate Cancer Trial Opens

Study to Explore Surveillance for Low-Risk Disease

When Houston restaurateur Tony Masraff was diagnosed with early-stage prostate cancer, his life was packed with dancing, running marathons, playing tennis, gardening, leading a successful business and spending time with his family.

But it wasn't until his doctor at M. D. Anderson advised "watchful waiting" as an alternative to invasive surgery and radiation that he realized he could continue his active life - free of treatment side effects, but with the cancer.

Masraff is one of about 200 M. D. Anderson patients diagnosed with low-risk prostate cancer on active surveillance for their disease. They are monitored through regular prostate-specific antigen (PSA) tests, biopsies and check-ups.

He also is one of hundreds of thousands of men nationwide who have had their prostate cancer detected by regular PSA tests at such an early stage that managing low-risk disease through surveillance may outweigh the risks and possible side effects of treatments.

Now, a new study at M. D. Anderson will follow low-risk patients eligible for watchful waiting to determine if they can avoid or postpone therapy and related side effects, and still live as long as patients who immediately receive invasive therapy.

When is a patient considered "low risk"?

"With the advent of the PSA test, we see prostate cancer detected much earlier, but there is no evidence that early detection (followed by treatment) means longer survival," says Jeri Kim, M.D., principal investigator on the study and associate professor in M. D. Anderson's Genitourinary Center.

"Because of the sensitivity of the PSA, clinically insignificant tumors sometimes are over-diagnosed and patients may, as a consequence, be over-treated with radiation and surgery."

Kim's study will enroll 650 patients with prostate cancer who have been diagnosed within the last six months and clinically defined in one of the following categories:

Low risk- These patients are considered to be in the early stages of prostate cancer. Cancer centers define "low-risk" differently, Kim says. At M. D. Anderson, patients with low-risk disease usually have a:

• Gleason score of less than or equal to 7
• PSA that is less than 4
• No more than one cancer-positive core biopsy

When a patient undergoes a biopsy after an elevated PSA result and/or abnormal digital rectal examination, tissue samples are taken from several areas of the prostate. These samples are called core biopsies. M. D. Anderson recommends that patients have at least 10 core biopsies. Some centers recommend more.

Localized and refusing treatment- These patients have been diagnosed with localized prostate cancer (confined within the prostate) and have refused early intervention.

Localized cancer patients ineligible for other treatments- These patients are precluded from therapy due to other serious health conditions.

Patients who have had previous treatment for their prostate cancer are not eligible to participate.

Study participants will undergo the following tests/procedures:

• Baseline biopsy (in some cases) to confirm diagnosis
• PSA tests and digital rectal exams every six months
• Additional biopsies if changes occur in tumor size
• Transrectal ultrasonography (annually) to detect changes
• Biopsy one year after study entry

Patients also will be asked to complete every six months:

• A general health survey
• Six short surveys on diet and behavior

"We'll be following patients over time to see what kind of psychosocial adjustment effects they are having knowing that cancer is in their body," Kim says. "I would think that it would be pretty anxiety-provoking, but after just our first 10 patients we're learning that patients are willing to postpone treatment when their tumors are small and there is high likelihood that they will grow slowly over time.

"Prostate cancer is one of only a few cancers that can be latent in the body for some time and not require immediate treatment. Watchful waiting is not for everyone, but it is a viable option for some patients with small tumors."

Patient and cancer co-exist happily

Tony Masraff, now 68 years old, preaches "watchful waiting" to men diagnosed with early prostate cancer and has yet to regret not having more invasive therapy. He is diligent, however, in keeping his appointments and follow-up tests.

"I decided my quality of life was worth more than having a tumor taken out or radiated," Masraff says. "I don't worry about my prostate cancer. I really don't have time to worry about it."

For more information, please contact the M. D. Anderson Information Line at 1-800-392-1611, option 3.