SURVIVING
PROSTATE CANCER
WITHOUT SURGERY

Comparison of Color-flow Doppler image (left) with conventional gray-scale ultrasound image (right).

Press Room

Sunday, March 1, 2009
WORLD’S LONGEST PROSTATE CANCER CURE RATES
(March 2, 2009 – Sarasota, FL) A long-term study revealing the longest reported cure rate for prostate cancer in the world was been presented at the annual meeting of the American Society of Clinical Oncology in Orlando, last week.

“Long-term outcomes for patients with prostate cancer having intermediate and high-risk disease treated with brachytherapy and supplemental conformal radiation” which reports an astonishing 16-year cure rate, was presented by radiation oncologist and principal investigator Michael J. Dattoli, MD.
The study consists of a group of 321 patients treated by Dr. Dattoli between 1992 and 1997, each of whom was diagnosed with prostate cancer categorized as at either intermediate- risk or high-risk of “extra-capsular extension.” 157 patients were categorized as intermediate-risk; 164 were high-risk. The stratification conforms to National Comprehensive Cancer Network guidelines and is of importance because it defines whether the cancer cells are at risk of having spread beyond the prostate gland, making “cure” by traditional surgical approaches virtually impossible.

These patients were treated with combination radiation therapy, a protocol for which Dattoli has been a noted pioneer. The men were first treated with daily 3-D conformal pelvic radiation, followed by palladium-103 brachytherapy (seed implant) using generous margins.
Cure, defined as “actuarial freedom from biochemical (disease) progression” was found to be 82% at 16 years (89% for intermediate-risk patients; 74% for high-risk).

“This study is encouraging for any man with intermediate or high-risk disease,” notes Dattoli, “as it confirms that combination, brachytherapy-based treatment regimes have proven to be effective options for these patients. These results are far superior to any reported with surgery (traditional or robotic) or with any other treatment options, with far less risk of the complications of erectile dysfunction or incontinence.”

Dattoli, and partner Richard Sorace, MD, at the Dattoli Cancer Centers & Brachytherapy Research Institute in Sarasota, Florida, have been perfecting the combination treatment protocol for over 20 years. “With the greatly advanced focal radiation technology we now have, we are confident that men – especially those with very aggressive disease – are seeing superior results to even those reported in this study,” Dattoli adds.

Look-back studies, such as this one, take many years to complete but are the foundation for progress in this field. “Our commitment to continuing the research and publishing these peer-reviewed studies is what will bring longer life and higher quality of life to prostate cancer patients in the future,” Dattoli states.
Already the extreme and often damaging radical surgery of the past 20 years is disappearing, as men now have proven options that defeat the cancer and preserve the quality of their lives after prostate cancer.

# # #

Copies of the study are available by contacting the Dattoli Cancer Center & Brachytherapy Research Institute – 877/​328-8654; www.dattoli.com


Special to: The Washington Post 8/​19/​2008

On Tuesday, August 5th, 2008; an article entitled, "To Screen or Not to Screen" was printed in the Washington Post. Dr. Dattoli wrote an editorial in response to the Post's article.

Regarding the news article, “To Screen or Not to Screen" (Aug. 19, 2008), I am writing to challenge the guidelines issued by the U.S. Preventive Services Task Force, which suggested that men over the age of 75 should not be screened for prostate cancer. Having spent more than 25 years studying this disease and treating more than 10,000 men, I am well aware of the dilemmas of when to treat and when not to treat prostate cancer. The current controversies in the field about the efficacy of treatment are directly related to the question of setting an age limit for screening. In my opinion, given recent trends in life expectancy for American males, a screening cutoff at age 75 is too early for many men who are otherwise in good health.

In the past, it was argued that prostate cancer patients with a life expectancy less than 10 years should not be treated, because they were more likely to die from some other cause. But with life expectancy increasing for the population as a whole, there are actually fewer and fewer cases of prostate cancer these days that do not call for some form of treatment. Older men should be evaluated on a case by case basis. The most recent SEER-Medicare data demonstrate a significant survival advantage for patients (ages 65 to 80) treated with radiation or surgery compared to patients who were not treated. Relatively noninvasive treatments, such as the most advanced radiation therapies (brachytherapy and/​or IMRT), are often appropriate for older men, including those over 75, who are otherwise in good health -- with less risk of surgical side effects that may reduce quality of life. In addition, a recent study has shown that in the early 1990's and as a result of PSA screening, the U.S. and U.K. had the same incidence of prostate cancer per capita; but since that time the U.S. has enjoyed more than a 4-fold decline in mortality compared to the U.K. And this was attributed directly to our TREATING elderly patients with definitive therapies vs watchful waiting, as is the method of choice in the U.K (Lancet Oncol. 2008 May;9(5):407-9).

According to the most recent actuarial data (National Vital Statistics Reports, June, 2008), even an 80-year-old man now has a life expectancy of 8.3 years, while a 75-year-old man can expect to live 10.9 years, and the trend is rising for all age groups. In the case of an 80-year-old whose general health is good and who has no other serious health conditions, he stands a good chance of living beyond 10 years and would be wise to consider treatment. A man’s overall health should be considered as well as his age, since an 84 year old may actually be healthier than his 54 year old counterpart who smokes cigarettes, consumes excessive alcohol, etc. While many doctors continue to use 10 years life expectancy as a strict benchmark, when biopsy pathology and other lab tests identify aggressive, potentially life-threatening tumors, a 5-year cutoff may be indicated, and that would suggest screening is appropriate for many men over the age of 75, who can be effectively treated with radiation and/​or hormonal therapy.

Michael J. Dattoli, M.D.
Physician-in-Chief,
Dattoli Cancer Center,
Sarasota, FL


Special to: Doctors Health Journal

NEXT GENERATION PROSTATE ULTRASOUND STUDIES
DEBUT AT DATTOLI CANCER CENTER

By Michael J. Dattoli, M.D.


Accurately diagnosing prostate cancer is essential to successful treatment. The widely used PSA blood test is only an indication of the relative health of the prostate gland, and as recent studies indicate, a low PSA can give a false sense of security to as many as 15% of men reporting them. The walnut-sized gland, deep in the man’s lower abdomen presents physical exam challenges because of its position in close proximity to many critical structures – such as the bladder, rectum and seminal vessels.

A biopsy is the definitive test for diagnosing prostate cancer. Most biopsies are performed utilizing ultrasound equipment which portrays images in hues of grey – the “grey scale.” Using this outdated method, biopsies are randomly spaced to obtain 6-12 cores. Since the cancer generally cannot be seen on a grey scale, this is something of a needle-in-a-haystack approach.

The color-flow Doppler prostate ultrasound, introduced to the West coast of Florida 4 years ago with the opening of our Cancer Center, brought a new perspective to diagnosing prostate cancers. The Doppler technology reveals in brilliant color areas of increased blood flow within the gland, indicating sites of suspected tumor growth. This information is profoundly important in planning the prostate biopsy, as it gives the physician color “targets” for the biopsy cores. Without this advanced study, randomly spaced biopsy cores often miss a cancer entirely and subject the man to repeat biopsies as the PSA level continues to rise. Precious time can be lost as inaccurate, costly and painful biopsies are repeated.

As good as the Doppler ultrasound is, until now is it has not been able to give a complete picture of the gland because of its two-dimensional nature and limited 3-D capabilities. With the addition of a brand new Sonocubic computer program, we are now able to look at the Doppler images in true 3-D. Areas of suspected tumor growth can be fully assessed from 360 degrees using this pioneering software. A three-dimensional and transparent model of the man’s prostate is created by the computer, adding greatly to the information needed prior to performing the all important biopsy. This model can be rotated on the monitor to view the transparent structure from all sides – actually making the technology 4-D.

Dattoli Cancer Center is the first installation of this software anywhere in the world. We expect this technology to greatly enhance our ability to accurately diagnose, stage and treat prostate cancers.


Special to: Renal & Urology News (Volume 3 No. 5) May 2004.

INCURABLE PCa? CONSIDER BRACHYTHERAPY
Used in conjunction with 3-D conformal EBRT, implanted seeds can successfully treat difficult cases

By Michael Dattoli, MD

Over the past decade, prostate brachytherapy has gained increasing popularity for the treatment of prostate cancer, especially in view of the favorable side-effect profile when compared to alternative therapies. The number of patients treated with this modality is now on par with both radical prostatectomy and full-course external beam radiotherapy (EBRT) as the primary treatment for early stage prostate cancer.
Despite entering the mainstream, patients diagnosed with intermediate and locally advanced high-risk prostate cancer are often discouraged from undergoing brachytherapy. Instead, their physicians frequently recommend radical prostatectomy, full-course external radiation with or without hormones, or hormones alone.

In contrast to these practices, prostate brachytherapy can be an effective treatment option for these patients. A recent report in Cancer (2003; 97:979-983) demonstrates patients undergoing palladium 103 (Pd-103) brachytherapy (using TheraSeed, Theragenics Corp.), along with supplemental 3-D conformal EBRT, experience long-term outcomes superior to either radical prostatectomy or full-course EBRT – with fewer side effects.

These data are important because the vast majority of patients treated in the study were considered categorically incurable using any other treatment method, especially radical prostatectomy. Still, 79% of these patients remain cancer-free after 10 years without the subsequent need for hormonal therapy or chemotherapy.

Another advantage to radioactive implants vs. conventional therapy such as surgery is that it is an outpatient procedure. The patient returns to routine activities within a day or two, in contrast to weeks or even months to fully recover from a radical prostatectomy. Meanwhile, supplemental 3-D conformal EBRT is delivered on an outpatient basis, takes only minutes per day, and is associated with minimal symptoms. This reduced side effect profile can be attributed to the fact that the combined radiation/​brachytherapy regimen requires an attenuated external beam dose when compared to full-course radiation regimens. The implants remain in place permanently and become inactive in approximately two to three months.

Physicians at Memorial Sloan-Kettering Cancer Center in New York first began using brachytherapy to treat prostate cancer in the early 1970’s, but had no way to position the seeds other than making an abdominal incision and exposing the prostate gland. They used needles to insert seeds one-by-one in a blood-filled field, making satisfactory seed distribution difficult. As a result, the implant procedure was not always successful and fell into disrepute.

However, the development of transrectal ultrasound imaging in the early 1980’s made it possible for physicians to use real-time imaging to guide seed-bearing needles into the prostate. Ultrasound-guided implants enabled physicians to more easily deposit radioactive seeds throughout the gland. Success rates improved dramatically. In the aforementioned report in Cancer, there is evidence supporting the use of this procedure in intermediate- and high-risk patients.

The study included 161 patients with advanced high-risk prostate cancer treated with brachytherapy between 1991 and 1995. Each patient had at least one of the three high-risk features (see Table); 77% had at least two or more high-risk features; and 66% had all three. The median patient age was 67.

All patients’ pre-treatment risk factors, except for staging, were independently reviewed by a team of physicians at the University of Washington in Seattle. Clinical staging using DRE was not included because it was subjective rather than objective (although 60% of patients had locally advanced T3 malignancies). Forty-three percent of patients had PSAs greater than 15; 70% had PSAs greater than 10, and 30% had elevated PAPs. Sixty-five percent of patients had Gleason scores greater than 7.

Patients were treated with Pd-103 seeds with a minimum brachytherapy dose of 8,000 to 9,000 centigray and supplemental external beam radiation doses of 4,140 to 5,040 centigray. None of the patients in the study received iodine (I-125) implants; the investigators prefer Pd-103 seeds because of their non-migrating concave shape and steep radiation fall-off.

Despite the aggressive nature of the cancers in this study group, no local recurrences were documented, even in patients with biochemical failure, all who underwent restaging prostatic biopsies. Ten years later, 79% of patients had PSAs of less than 0.2 ng/​mL, which is considered disease-free by the strictest of biochemical measures. In addition, 70% of patients in the study retained potency. No patient experienced rectal ulceration and only one patient – who had undergone two transurethral surgeries – experienced low-volume stress incontinence.

The failure rate is not as significant as it may seem at first glance. Only two of the 20% of patients with rising PSAs following treatment died from their disease; the remainder were considered failures because a very low PSA nadir was chosen to denote cure, and they simply did not meet this strict post-treatment PSA criteria. In fact, many have stable PSAs between 0.3 and 4.0. They are functioning well, believe they are cured, and probably are cured. Finally, with the advent of Intensity Modulated Radiation Therapy (IMRT), coupled with Pd-103 seeds, even fewer side effects are anticipated.

Dr. Dattoli is a board-certified radiation oncologist, and a noted author and speaker in this complex field of medicine. He is currently physician-in-chief at the Dattoli Cancer Center & Brachytherapy Research Institute, Sarasota, Florida.


High-Risk Features
PSA greater than 10
Elevated prostatic acid phosphatase
Gleason score between 7 and 10

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