Observation is safe, cost-effective, and results in a better quality of life for patients with low-risk, localized prostate cancer, rather than undergoing immediate treatment, says a study carried out at Massachusetts General Hospital and the Dana-Farber Cancer Institute.

The study findings were published in Annals of Internal Medicine.

According to the authors, their statistical models demonstrated that for 70% of men with low-risk prostate cancer at diagnosis “observation is a reasonable and, in some situations, cost-saving alternative to initial treatment.”

Julia Hayes, MD, and team believe that their findings confirm that active surveillance and watchful waiting, often referred to as observation, is a reasonable option with low-risk prostate cancer – an option that is underused.

Dr. Hayes said:

“About 70 percent of men in this country have low-risk prostate cancer, and it’s estimated that 60 percent of them are treated unnecessarily.”

This is a huge number of patients with low-risk prostate cancer who either receive some form of radiation therapy or undergo a radical prostatectomy (their prostate gland is surgically removed), and face the pain and discomfort of treatment, plus the risk of urinary incontinence and erectile dysfunction.

Localized Prostate Cancer – Removal No Better Than Observation – the (low) risk of death over a 12-year period for newly diagnosed patients with low-risk prostate cancer who underwent a radical prostatectomy is the same as for those who opted for observation, according to a clinical trial called PIVOT, which was published online on 19 July in the New England Journal of Medicine.

Dr. Hayes and colleagues looked at a range of scenarios using mathematical models they had created. They concentrated on male seniors aged between 65 and 75 at diagnosis. They also compared estimated costs that are associated with several forms of observation and treatment.

Patients who are advised to undergo active surveillance and chose this option:

  • Undergo a blood test every three months to measure levels of PSA (prostate specific antigen
  • Undergo a rectal examination twice a year
  • Have a prostate gland biopsy at one year and then every three years

If things remain the same – PSA levels stay fairly constant, rectal examinations reveal nothing unusual, and the biopsies results show the prostate cancer continues to be low risk – the “watchful waiting” continues.

If at any time tests show that the cancer has become more aggressive, or is more aggressive than originally thought, treatment aimed at curing the disease begins. Hayes said “This approach could also be described as deferred treatment.”

Patients with low-risk, localized prostate cancer who opt for treatment to cure the disease may undergo:

  • Radical prostatectomy – surgery to remove the prostate gland and some of the tissue around it.
  • IMRT – intensity-modulated radiation therapy. This is a type of 3-dimensional radiation therapy. Computer-generated images are used to show the shape and size of the tumor. Thin radiation beams of different intensities are aimed at the tumor from several angles. With this type of radiation therapy there is less damage to healthy tissue close to the tumor.
  • Brachytherapy – radioactive seed implants are placed within or near to the tumor. Sometimes known as internal radiation therapy or implant radiation therapy.

The team calculated and compared the quality-adjusted life expectancy (QALE) for patients undergoing observation versus treatment.

QALE measures both the quality and the quantity of life lived – it is a measure of disease burden. Quantity of life lived is easy to measure. Factors that influence quality of life include having to undergo invasive tests, the impact of the treatment, disease recurrence, and complications.

The investigators also calculated what the lifetime costs are for each strategy. They ranged from $48,699 for a 65-year old man treated with IMRT therapy to $18,302 for a 75 year-old patient who opted for watchful waiting.

For patients newly diagnosed with localized, low-risk prostate cancer, the researchers concluded that:

  • observation is more effective than initial treatment
  • observation in some cases is less expensive than initial treatment
  • observation yielded 11 months more QALE than brachytherapy (the most effective treatment)
  • observation yielded 11 months more QALE than radical prostatectomy (the least effective treatment)

The team admitted that their study made assumptions based on limited research data, but concluded that:

“It appears that active surveillance and watchful waiting are safe alternatives to initial treatment for prostate cancer based on these assumptions. But it’s important to emphasize that these decisions are very much a matter of individual choice.”

Co-author Philip Kantoff, MD, said “This study delineates the cost benefit of active surveillance as well as watchful waiting – the less aggressive assessment strategy. A previous study by Dr. Hayes and colleagues demonstrated that active surveillance is a reasonable option for men with low-risk disease and associated with a better quality of life. As non-treatment becomes a more accepted option for these patients, selecting those who require less aggressive assessment including biopsy will become important.”

A study carried out at the Case Western University School of Medicine in Cleveland, and presented at the American Society for Therapeutic Radiology and Oncology’s 49th Annual Meeting, Los Angeles, in 2007, found that prostate cancer patients who undergo brachytherapy have a 50% lower risk of dying compared to those on watchful waiting/active surveillance.

Prostate cancer patients with low risk tumors may safely defer treatment for many years, researchers from the Beth Israel Deaconess Medical Center reported in the Journal of Clinical Oncology (September 2009 issue).

Study co-author Martin Sanda, MD, said “With the advent of PSA [prostate antigen] screening nearly 20 years ago, we started to detect prostate cancers at much earlier stages. Consequently, while PSA testing has enabled us to successfully begin aggressive treatment of high-risk cancers at an earlier stage, it has also resulted in the diagnosis of cancers that are so small they pose no near-term danger and possibly no long-term danger.”

Written by Christian Nordqvist