Sometimes No Treatment is the Right Option for Low-Risk Prostate Cancer, But More Research is Needed, M. D. Anderson Team Says

March 22, 2006. 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 Houston restaurant operator 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 The University of Texas M. D. Anderson Cancer Center advised "watchful waiting" as an option 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 men diagnosed with low-risk prostate cancer at M. D. Anderson on active surveillance for their disease, having changes 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 outweighs the risks and possible side effects of treatments.

M. D. Anderson plans to tests more men who are willing to pursue watchful waiting with a view to gathering key information for the future development of guidelines fordoctors and their patients.

"With the advent of the PSA test, we see prostate cancer detected much earlier but there is no evidence that early detection means longer survival. Because of the sensitivity of the test, clinically insignificant tumors sometimes are over-diagnosed and patients may, as a consequence, be over-treated with radiation and surgery," said Jeri Kim, M.D., principal investigator of the study and assistant professor in the Department of Genitourinary Medical Oncology at M. D. Anderson.

The study will enroll 650 prostate cancer patients who have been clinically defined either as low risk, or patients with localized prostate cancer who have refused early intervention, or patients with localized cancer who 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.

Patients will have a biopsy at the beginning of the study to confirm the diagnosis of localized prostate cancer followed by PSA tests and digital rectal exams every six months. The need for additional biopsies will be determined at the end of the first year of surveillance, and participants on the study will be given a transrectal ultrasonography annually to detect any possible changes.

Patients also will be asked to complete a survey on their general health conditions as well as six other short surveys which will be used to monitor diet and behavior as part of related research.

Prostate cancer is one of only a few cancers that can be latent in the body for some time and not require immediate treatment," said Dr. Kim. "Many researchers have documented over the years that men die with their disease rather than from it, and while we need to intervene early, we also need to intervene appropriately with respect to the stage of disease, the man's age, his health in general and quality of life."

Tony Masraff, now 68 years old, preaches "watchful waiting" to men diagnosed with early prostate cancer and has yet to regret not having a more invasive therapy to rid him of the cancer. 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," said Masraff. "I don't worry about my prostate cancer. I really don't have time to worry about it."

M. D. Anderson's policy on "watchful waiting" for prostate cancer is as follows:

Because not all prostate cancers will progress to threaten patients' lives, M. D. Anderson does consider watchful waiting as a treatment option for very carefully selected patients with low-grade prostate cancer. These patients fall into two general categories:

Patients who believe the side effects of treatment (impotence, urinary incontinence) are excessive. Watchful waiting would be considered for these men if they:

• Recognize there is no validated screening method for early detection of disease progression
• Have a low Gleason score
• Have low-volume disease
• Have a PSA level within the normal range (or accounted for by an enlarged prostate)
• Are willing to submit to follow-up with annual biopsies and quarterly PSA tests

Patients in whom the risk for cancer is less than the risk from unrelated, co-existing health conditions.  Watchful waiting would be considered acceptable if:

• Patients have a less than 10-year expected survival
• The Gleason score is low
• Patients have low-volume disease
• The PSA level is within the normal range 
• Patients have an estimated survival of less than 5 years and a cancer judged not to be at risk during that time
• Patients are willing to submit to follow-up with quarterly PSA tests and annual biopsies 

The challenge of watchful waiting is that oncologists still cannot anticipate progression of the disease in a timely enough fashion to avoid risky treatment delays, and there are still no reliable methods to select patients in whom cancer is unlikely to spread. As the ability to predict prostate cancer progression improves, the risks of watchful waiting can be minimized.

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This article posted March 22, 2006 by J. Strax.