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Comprehensive Treatment Protocol

What is High Risk Prostate Cancer?
There are different definitions. Basically, it is localized prostate cancer which because of a high PSA, high Gleason score, or advanced stage has a high chance of recurring after treatment or of spreading to other areas of the body. Our definition is:

PSA of 20 or higher, or
Gleason score of 8 or higher, or
Tumor stage of T3 or higher on digital rectal exam (tumor is already extending outside of prostate gland)

We also include early or possible pelvic lymph node involvement in this group because we will tend to use the same treatment

Patients with intermediate risk prostate cancer (PSA 10 - 19.9, or Gleason 7, or cancer felt/seen on both sides of prostate gland -- stage T2b) may wish to consider this protocol if they have more than one of these risk factors present.

What are the common treatment options for high risk PCa?

Radical prostatectomy. Tends to be a bad option because of the high chance that the cancer has already escaped outside the prostate gland. Prostatectomy removes the prostate only. If there are cancer cells beyond the prostate gland which surgery leaves behind, they will form new tumors in time, and the prostatectomy (and associated side effects) will have been for nothing.
External beam irradiation. This can also treat the seminal vesicles, the fat surrounding the prostate gland, and the pelvic lymph nodes. However, the cure rate tends to be quite low for high risk PCa. Adding hormonal therapy for 4 to 36 months in conjunction with the radiation will improve results substantially. Some forms of radiation like 3D, IMRT, or protons can be used to give a higher dose to the prostate gland, and result in a higher cure rate.
Brachytherapy. (Permanent or temporary radioactive seed implant). This should be done in combination with external beam radiation. The brachytherapy allows the prostate to safely receive a high dosage of radiation, increasing the cure rates.
Hormone therapy. This can be used as the sole form of treatment for PCa. However, it probably cannot cure the cancer, unless it is combined with another treatment like radiation / brachytherapy. There are different drug combinations available for hormone therapy. We prefer to use Triple Hormone Blockade (= triple androgen deprivation= AD3), which is a combination of three hormonal therapy drugs.

CTCA - Tulsa Treatment Program
Our program is designed to offer what we consider to be the most significant advances in the field of radiation medicine and hormonal therapy. The treatment gives a very high dosage to the prostate gland, and also addresses the possibility of cancer outside the prostate gland or in the pelvic lymph nodes. We also address the factors that led to your development of prostate cancer in the first place. Our quadruple modality treatment program consists of:

Triple hormone blockade (AD3)
High dose rate brachytherapy (HDR)
External beam irraditaion (EBRT)
Optimization of diet, supplements, lifestyle

1. Triple Hormone Blockade
We believe the most effective hormone therapy regimen is a combination of three drugs:

Lupron or Zoladex injections, which stops testosterone production by the testicles
Eulexin or Casodex tablets, which block testosterone binding sites on cancer cells
Proscar tablets, which stop the conversion of testosterone to its more active form, dihydrotestestosterone.

We use this combination until the PSA drops down to 0.10 or less, and continue it for 9 more months beyond that point, for a total duration of 15 months or so. In some patients the PSA may never drop this low, and this plan may be modified.

The HDR brachytherapy is usually performed 3 to 6 months after starting the hormonal therapy.

When the hormonal therapy is eventually stopped, Proscar 5 mg daily is continued forever as "maintenance therapy" to help reduce the chance that the PSA will rise in the future. This drug has minimal side effects, and is also marketed as "Propecia" to help balding men grow hair. The triple hormone therapy does cause some side effects, and we will monitor these and we have some ways to reduce those side effects.

2. High Dose Rate (HDR) Brachythytherapy

This treatment involves a 24 hour stay in hospital. Plastic needles are inserted into the prostate gland under anesthesia and ultrasound guidance, and three radiation treatments of 650 - 700 cGy each are given through the needles over 24 hours. Because of the large dose per treatment, this dose ends up being equivalent to approximately 5700 cGy of radiation (based on alpha-beta ratio of 4.9, tumor receiving >= 110% of prescribed dose, and 675 cGy * 3 fractions). When this is added to the 4500 cGy of external beam irradiation, this represents a huge dose to the cancer. The plastic needles can also reach extra-capsular cancer that has broken out into the tissue beside the prostate gland, or that has extended up into the seminal vesicles.

3. External Beam Radiation Therapy (EBRT)
At CTCA - Tulsa, we have 3D conformal radiation and IMRT (intensity modulated radiation therapy). However, for high risk cancer, it may be better to treat the entire pelvis with standard radiation techniques, so that all the lymph nodes in the pelvis can be treated. Even if no cancer is seen in the lymph nodes on scans, there still may be small amounts in them (micrometastases).
The risk of having cancer in the lymph nodes can be estimated by the Partin tables , and is usually in the range of 5 - 40% for high risk cancer. If your risk is less than 10 - 15%, or if you have a strong desire to avoid external beam radiation to the entire pelvis, then we can use 3D conformal EBRT or IMRT instead.

Because only a moderate EBRT dose of 4500 cGy is used, the side effects will tend to be mild and temporary. In comparison, patients who are treated with EBRT alone without brachytherapy will usually receive over 7000 cGy.

4. Optimizing Diet, Supplements, and Lifestyle

Patients are encouraged to meet with our nutritionists, naturopathic physicians, and psychoneuroimmunology (PNI) specialists. Although we believe our treatment to be state-of-the art, there are things you can do for yourself which will maximize your well-being, and your body's chance of curing or controlling the cancer. We have an outline of our plan available on our website, but this will be individualized when you meet with the specialists. We seek to reverse the conditions in your body which lead to the development of prostate cancer in the first place. This natural / alternative therapy is being used to complement our traditional therapies. Various supplements can also help reduce the side effects of radiation, brachytherapy, and hormonal therapy.

Our recommended diet involves properly balancing your carbohydrates / protein / fat calories, with emphasis on vegetables, fruit, soy, and some fish. Sugar, refined carbohydrates, animal fats, dairy fat, certain vegetable oils, and red meat are limited.

Our supplement program includes Vitamin E, Selenium, EPA/DHA omega-3 oil, Lycopene, Multivitamin, Vitamin D3, zinc, and other individualized supplements.

Roles of the Different Specialists in the ZeroPSA Protocol

Nutritionist

Discuss the prostate cancer diet.
Review of best proteins, fats, and carbohydrate sources and amounts to eat
Weight and calorie goals

Naturopathic Doctor

Body composition analysis (% body fat, etc.)
Vitamin / supplement prescriptions
Natural immune system stimulation
Natural management of other health problems
Smoking cessation if necessary / desired

Psychologist (psychoneuroimmunology or PNI)

Stress reduction
Coping with cancer
Assessment of any anxiety or depression problems
Mind - body - cancer connection, imagery
Spirituality needs

Physical Therapist

Exercise program
Breathing and relaxation exercises

Radiation Oncologist

Coordination of treatment
Brachytherapy
External beam radiation
Hormonal therapy
Testing
Follow-up visits and monitoring

Results of Treatment
There are no results available yet available for this particular treatment combination, as it is unique. We expect that overall somewhere between 55 - 90% will be free from cancer recurrence within the first 5 years after treatment. Your chance of cancer recurrence depends upon your initial PSA, grade, and tumor stage. With a successful treatment, the PSA should drop to 0.1 or less during treatment, possibly rise slightly when the hormone therapy is stopped, then ultimately level off at less than 1.

Follow-Up Schedule
We will normally see you every 3 months while you are still on the hormone therapy to give you your next hormone therapy injection, to check your blood tests including PSA, to check your prostate gland, and to monitor for side effects and treat them if necessary. Once the hormone therapy is completed, we will typically do a follow-up every 3 - 4 months for the first 2 years, then every 6 months thereafter as long as your PSA remains low. Some (or all) of these follow-ups can be arranged through your local doctor if necessary.

What Happens if the Cancer Recurs after Treatment?
Despite HDR + EBRT + AD3 hormonal therapy + natural therapy, a certain percentage of high-risk PCA patients will develop cancer recurrence in the years following treatment. If the PSA starts rising, we will do scans and possibly another biopsy to determine where in the body the cancer is recurring. In many cases, the recurrence will be in the lymph nodes or bones because of the risk that micrometastases were already present at the time treatment was given.

The usual recommended treatment for recurrence of high risk PCa will be to go back onto hormone therapy. Typically, once the PSA rises to 2.5 - 5.0, or once the cancer is found in the bones or lymph nodes, we would restart triple hormone blockade. This will be given intermittently if possible, cycling on and off. This is also known as IAD3 or intermittent triple androgen deprivation.

To Find out More Information
Pattie or Sharon can provide information about our center, treatment, insurance issues, and travelling and lodging arrangements at 1-800-788-8485 ext 5170.

Questions and Answers
Q. Is it dangerous to wait 3 - 6 months before starting HDR brachytherapy?
A. No, because while you are on hormone therapy it will lower the PSA, kill many cancer cells, shrink the tumor, and shrink the prostate gland. Once you start the hormone therapy you are on cancer treatment.

Q. The pills are expensive for triple hormone blockade. Can I just take the injections? Can I take the drugs for a shorter time period?
A. The results are probably best to take all 3 medications for the prescribed time period of 13 - 16 months. There are some ways to get the pills for free if you meet financial criteria and there may be some ways to get the drugs at a discount.

Q.Can I take the external beam radiation at home?
A. Although we prefer to take responsibility for all the treatment, we can work with your doctors at home.

Q. Why do you do HDR temporary brachytherapy instead of permanent seed implant?
A.We've done both at our center and we feel there are several benefits to HDR , including greater control of where the dose goes, ability to give more radiation to the tumor itself, ability to treat outside the prostate gland, possibly less side effects, and no radiation exposure to family, friends, or medical staff.

Q. Can I take Saw Palmetto instead of Proscar?
A. Although Saw Palmetto can be used instead of Proscar to treat benign prostatic hypertrophy (BPH), we are not using Proscar for this purpose. We are using it as part of triple hormone blockade, and Saw Palmetto may not be effective for this purpose. On this program we recommend that Saw Palmetto be stopped and that you take Proscar instead.