Prostate Cancer Patients Have New Medical Treatment

LOS ANGELES, April 18 /PRNewswire/—In the April 2001 issue of The Oncologist, triple hormone blockade was assessed among 110 prostate cancer patients with mean PSA scores of 13.2. Today, all patients are off treatment with prostates intact, without having undergone radiation therapy or surgery. The longest follow up is 10 years. No patient reported permanent side effects after treatment concluded and to date, none required re-treatment. Physician originator says treatment marks "the beginning of the end of surgical removal of the prostate."

For the nearly 180,000 prostate cancer patients diagnosed this year, current medical options include watchful waiting, radiation therapy or radical prostatectomy to surgically remove the cancerous prostate. Recent studies indicate that such invasive treatments can cure some men but this cure comes at a heavy price to the patient including risk of permanent urinary incontinence, fecal incontinence and/or impotence. During the past two years, several medical studies have pointed out the high failure rates of these therapies, as well as the increasing percentage of patients left with permanent side effects and drastically altered quality of life. Nearly 32,000 men die of the disease in the U.S. each year.

For more than 50 years, hormone blockade therapy has been used only as treatment for patients whose invasive treatments failed or who were initially diagnosed with metastasized prostate cancer. Until now, that is. For the first time, this study explains how triple hormone blockade alone successfully treats patients with clinically localized or locally advanced prostate cancer without surgery or radiation therapy.

With the publication of this study detailing the treatment of prostate cancer with only 13-months of a three-drug hormone blockade protocol, it appears men now have another viable medical option in their war against this disease.

"With convincing evidence of a real alternative now at hand, I believe this will be the beginning of the end of radical prostatectomy as the gold standard for treating prostate cancer," concluded Robert Leibowitz, M.D., originator of the triple hormone blockade as sole treatment for the disease. Dr. Leibowitz is a board-certified hematologist/oncologist in Los Angeles, CA sub-specializing in the treatment of prostate cancer. He is also a former clinical instructor and research fellow at the Harvard Medical School.

Dr. Leibowitz conducted the evaluation of 110 consecutive patients to determine the effectiveness of triple androgen blockade as an alternative to such options as radiation or surgery for those with clinically localized or locally advanced prostate cancer. The content of the study shows the following: For an average of 13 months, patients were treated with a three-drug androgen blockade regimen that blocks production of male sex hormones (testosterone). Treatment included the use of injectible luetenizing hormone-releasing hormone agonist every 28 days, daily oral doses of antiandrogen plus daily oral doses of finasteride. Oral finasteride is the only maintenance therapy.

"We use the same hormone-blocking medicines that urologists or radiation therapists use after their treatments fail," noted Dr. Leibowitz. "We just do it sooner."

On average, patients were age 67 with a PSA of 13.2 and Gleason score of 6.6. No patient in the study had undergone radiation or surgery. It took patients approximately three months to achieve undetectable PSA levels. For the first 57 patients who completed treatment, the average PSA is 1.88 with a median follow up of nearly five years. For all patients currently off treatment, the average PSA score is 1.3. As of October 2000, no patient in this series has required re-treatment.

An enormous benefit of triple hormone blockade is that it can successfully treat cancer cells that may have escaped from the prostate, wherever they are in the body. The authors believe cancer cells are already outside of the prostate in well more than half of all men diagnosed with prostate cancer today.

During treatment, most patients reported temporary symptoms associated with triple hormone blockade therapy including hot flashes, loss of libido and impotence. Upon treatment conclusion, such symptoms almost always reversed. On average, patients started treatment with a baseline testosterone of 373 that was clinically taken down to zero. One year after treatment ended, average testosterone levels were higher than before treatment began and averaged 412.

The most promising news from this evaluation is that 100% of patients treated achieved undetectable PSA levels while on short-term triple hormone blockade. Following treatment, most patients achieved a "stable PSA plateau" rather than continuously rising PSA numbers. Dr. Leibowitz notes that with this report and others, a reassessment of currently accepted options for treating localized prostate cancer is essential. He also calls for prospective, randomized clinical trials to evaluate hormone blockade therapy alone compared to surgery or radiation therapy.

"We are hopeful that this study will help men understand that they have more treatment options than they think when diagnosed with prostatecancer," says Dr. Leibowitz. "Triple hormone blockade is a viable therapy for thousands of men, and starting today, they should be made aware of this option when deciding how to treat their disease."

For the full text of this study, please go to the journal's current issue on their website at www.TheOncologist.com. For a list of patients from across the nation and internationally who have successfully been treated with triple hormone blockade or to reach Dr. Leibowitz directly, please call 310/229-3555.