Intelligent watchful waiting is an improved version of watchful waiting, which turns it from passively doing nothing to an active treatment.

Watchful Waiting is the term used to describe non-treatment of prostate cancer. The "watchful" part means keeping an eye on the cancer, "waiting" to start treatment at a later date if it is needed. The theory behind this is that prostate cancer tends to grow slowly, and often patients will die from an unrelated condition (like heart disease) before the cancer causes symptoms.

Watchful waiting means different things to different physicians and patients. To many, the term has come to mean little more than avoiding conventional therapy. Some patients choose WW because they are afraid of treatment and the side effects. An encounter with a negative physician can prompt a patient to choose WW rather than seek their recommended treatment. WW also can be a form of denial that a cancer really exists or is a serious threat.

Most patients do absolutely nothing for their prostate cancer while they are on watchful waiting. They continue eating and living the same way they always have, which ultimately allows the prostate cancer to continue growing in the same environment which created it. This is why watchful waiting means doing nothing to most people. For many, it means being passive and hoping that an unrelated condition will cause their death.

The waiting part is also very subjective. Some patients panic at the slightest rise in their PSA and will start conventional therapy. However, PSA measurements can fluctuate up and down by up to 30% from day to day. A rise in PSA from 6.5 to 7.5 can be meaningless. for example. Other patients may be told by their physician that the prostate nodule seems to "feels bigger", and they start treatment. However, digital rectal exams are notoriously inaccurate and subjective. What many patients lack is an accurate sense of their goals while on watchful waiting. They are unsure when they should stop WW and start conventional therapy.

1. Analyzing if you and your cancer are suited for iWW
2. Determining in advance why you are choosing iWW, what your goals are, and what your limits will be for starting conventional therapy
3. Optimizing your diet, supplements, and lifestyle to slow down the natural growth rate of the cancer, and to reverse the conditions which lead to developing prostate cancer
4. Setting up a program to monitor the growth of the cancer

Other names I have considered calling intelligent watchful waiting are "watchful wellness" or "active watchful waiting".

Prostate cancer will typically go through the following stages, and can be diagnosed at any point in the process.

1. Clinically insignificant prostate cancers commonly occur (often found on autopsies of older men).
2. Through a DNA mutation or some type of stimulating factor, an insignificant cancer becomes significant, and starts growing.
3. PSA begins to rise.
4. A nodule in prostate can be felt on rectal exam (DRE) by your physician.
5. Nodule grows in size, may extend throughout the prostate gland and be felt on opposite side of the gland.
6. Cancer breaks through the prostate capsule into surrounding fat or seminal vesicles, and may eventually extend into bladder, rectum, and pelvic muscle.
7. Cancer cells spread through lymphatic vessels into pelvic lymph nodes, and eventually into other lymph nodes throughout the body.
8. Cancer cells spread through the bloodstream to the bones, especially in the pelvis and spine.
9. Cancer cells may eventually spread to other organs like the liver, lungs, and brain.
10. Death occurs from multi-organ failure, infection, blood clotting, or other complication.

If you look at the staging systems for prostate cancer, you will see that the stages progress approximately through this list. Many prostate cancers grow slowly, so a patient will frequently die from an unrelated medical condition (like heart disease) before his cancer can pass through all these stages.

From published studies we can estimate the risk of cancer progression for the various stages, the risk of cancer spreading through the body (metastases), and the risk of dying. However, what we do not know from these studies is what these patients odds of progression would have been if they had followed conventional therapies like surgery or radiation. Perhaps there would not have been much difference in outcome. Without randomized studies, where patients are randomly chosen to undergo either watchful waiting or conventional treatment, we cannot really know if patients choosing conventional therapy will do significantly better.

In addition, there are other factors which mean that these WW study results may not be able to be applied to your situation. These factors are:

1. WW studies are generally from the pre-PSA era, and these patients had more advanced cancers at diagnosis than do today's patients. Today's patients are diagnosed earlier, and probably live significantly longer before their cancers progress.
2. There are no watchful waiting results available for cancers which cannot be felt on DRE, but rather were diagnosed on the basis on an elevated PSA alone. This represents a large number of today's prostate cancer patients.
3. These studies used various criteria for stopping watchful waiting and going on conventional therapy, likely different criteria than you will use. For instance, they did not use PSA measurements as a criteria for exiting watchful waiting.
4. The patients on these WW studies were merely passive participants, who did nothing active such as implimenting optimum diet, supplements, and lifestyle while following WW. Their cancers would be expected to continue relentlessly progressing in the same environment that created them.

In short, the WW studies can only be used as a very rough guide to what can be expected while following an intelligent watchful waiting program. These WW studies are accurate to refer to if:

• Your cancer was discovered on a DRE (rectal exam) or a TURP (removal of excess prostate tissue via instruments placed into the urine passage)
• You do not follow any sort of optimal diet / supplements / lifestyle while on WW
• And you do not use PSA to monitor for cancer progression while you are following WW.

Adolfsson used watchful waiting on 61 patients with stage T1 and T2 patients with moderate or well differentiated tumors (Gleason 2 – 6), who were all diagnosed by either TURP or DRE. This was in the pre-PSA era. He found that the number of patients who had metastases or died of prostate cancer was comparable to the relative numbers reported after radical prostatectomy and radiation therapy. He also reported on a similar group of 50 stage T3 patients (with extracapsular extension) who underwent watchful waiting.

These studies appear to demonstrate the slow but relentless progression of these patients from stage T1/T2 to T3, to distant metastases, and then ultimately to death.

Chodak Pooled Analysis Study

Dr. Chodak analyzed the results of all 6 studies on watchful waiting which had been published from 1985 through 1993. He found that cancer grade (Gleason score) was the most important factor in determining which cancers will progress on watchful waiting.

Progression rates at 10 years on watchful waiting

Gleason 7 - 10 tumors carried a high risk of developing metastases and dying from cancer. These results would suggest that watchful waiting may not be good option for Gleason 7 – 10 cancers, especially those which were detected on a DRE or TURP as they were on these studies.

There are some theoretical advantages to choosing iWW over conventional therapies. I say theoretical, because while regular WW has been researched in clinical studies, iWW has not been. As well, there are also some disadvantages of choosing iWW / WW over conventional therapy.

• No added risk of impotency. Potency (sexual ability) may actually improve with optimum diet, supplements, and lifestyle.
• No added risk of incontinence (loss of urine control).
• No added risk of other side effects like rectal or bladder damage, urinary obstruction, and post-operative pain and recovery.
• A majority of prostate cancer patients will not die from prostate cancer, and many patients with prostate cancer will not develop symptoms of the cancer during their lifetimes. iWW can spare many people from ever having to undergo conventional therapy.
• The number one reason why prostate cancer patients die is probably heart disease. Reversing poor health with the iWW optimum diet, supplementation, and lifestyle may help reduce the risk of dying of heart disease and other causes. Ironically, iWW may be the one treatment which can significantly increase life span in localized prostate cancer because of its effects on overall health.
• iWW can give you an assessment period, to see if your cancer is progressing, and to decide whether you want to pursue conventional therapy.
• iWW may give you the option of delaying conventional treatment.

• You may be criticized by family, friends, physicians, and others. You will have doubts about whether you are doing the right thing.
• Your cancer may spread to lymph nodes or bones while you are following iWW. In many cases, this will be because micro-metastases were already present at the time you were diagnosed, and your cancer would not have been curable even then by conventional therapy. In some cases, it may be because the first metastasis occurred while you were on iWW. If you develop metastases it will make you wonder when it first spread.
• There are no well defined PSA values above which metastases are likely. You cannot accurately say "As soon as my PSA hits ten I will start conventional therapy and avoid metastases". There is a risk of metastases at any PSA level, which gradually increases as the PSA increases. You must determine your own personal comfort / discomfort levels at which you will choose to exit iWW and seek conventional therapy.
• iWW can bring a far greater level of personal responsibility to your treatment than does completely handing over your care to a physician. For some men, this makes them more comfortable. For others, it is very stressful.
• If you are planning on eventually undergoing conventional therapy for cure, as time goes by the chance of cure will gradually decrease.

Who I think are good candidates for iWW

Patients have a right to choose whichever available treatment option is comfortable to them. This includes the right to choose no treatment, to choose an alternative treatment alone, or even to choose a treatment which is thought to be inferior, without being chastised by the medical community. This is especially true in the treatment of localized prostate cancer, where none of the available treatments has been proven better than any other, and where neither radiation nor surgery has been proven to prolong survival. For this reason, I feel that iWW can be an option for any prostate cancer patient to follow if he wishes.

As I will discuss, there are some patients for whom iWW may be a better or worse option. For example, patients with early systemic spread of their cancer to the lymph nodes or a few spots in the bones may be able to improve their length of survival if they start hormone therapy immediately. For these patients, iWW may not be the best option.

To determine if iWW is right for you, you need to analyze how aggressive your cancer is, what your lifespan is, and what your demeanor is.

How Aggressive is Your Cancer?

1. Low Risk PSA less than 10, Gleason 6, or less, stage T1 or T2a
2. Intermediate Risk PSA 10 - 19.9, or Gleason 7, or Stage T2b
3. High Risk PSA greater than 20, or Gleason 8 - 10, or stage T3 - T4

It has been suggested that the ideal candidates for watchful waiting should have less than 10 years to live. Some studies indicate that prostate cancer which has been left untreated for more than 10 years will tend to have progressed and started causing symptoms and a risk of death. The published watchful waiting studies show that prostate cancer will slowly and relentlessly progress, and if you live long enough you will develop extracapsular extension, then metastases, and possibly eventually death. Of course, by following natural therapies while on iWW, the speed of cancer progression may become much slower, or even be stopped altogether. In that case, perhaps the cancer would take 20 years to spread systemically instead of 10. A second point to consider is that with careful monitoring of the PSA and with well chosen stopping points, you can start conventional therapy at an appropriate point if progression does occur.

Determining if someone has less than 10 years to live can be difficult. Statistically, this probably applies to men older than 70 - 75 years with average health, less than this for men with other significant health problems. Of course, there is no way to accurately predict lifespan for an individual.

Anyone who wants to follow iWW can, and already has at least some part of their demeanor suited to iWW. However, there are a few beliefs and desires which make someone well suited. Don't worry if you do not have all these beliefs.

• A belief that conventional therapies probably do not extend life-span significantly
• A belief that prostate cancers are being over-diagnosed and over-treated
• A willingness to improve overall health (*)
• A strong desire to avoid impotence and other side effects
• A desire to become more educated about prostate cancer
• A greater comfort level by being in charge of own health care

The most important factor which distinguishes iWW from WW in this list is the willingness to improve overall health -- to reverse the conditions which lead to the development of prostate cancer in the first place. A second factor is the desire to become more educated about prostate cancer, so that you can better know when to enter and exit iWW, and how to monitor the state of your cancer while you are on iWW.

• More vegetables, fruit, legumes, soy products, water and green tea
• Less animal fats, less saturated fats, less total fat. Use olive oil.
• Less meat, especially less red meat.
• Cold-water fish (tuna, salmon, pickerel, mackerel, etc) can be good.
• Less dairy products like cheese, milk, ice cream.
• Less processed foods, junk food, fast food
• Less sugar, candy bars, soda, and refined carbohydrates

• Core supplements = vitamin E, selenium, lycopene, omega-3 oil like EPA/DHA, vitamin D or D3, multivitamin, zinc
• Other optional supplements.

• Regular exercise
• Reduce stress
• Weight loss if you are overweight
• Quit smoking and other unhealthy practices

If your PSA increases from 7.0 to 7.5 will you panic, call your physician and schedule your prostatectomy for the following week? Or will you calmly reflect that PSA values can fluctuate up and down, and that it still has a long way to go before reaching the 50% increase to 10.5 which you set as your stopping point?

This is why you need to determine your goals and your stopping points in advance, to help avoid anxiety and uncertainty if your PSA goes up slightly, and to avoid sudden emotional decisions to go with a conventional therapy. You may want to write your stopping points down somewhere, maybe on a computer file. You can always modify them later, after careful thought.

There are several types of exit points which you can use, and it is best to use a combination of them. These possible exit points include PSA changes, local cancer progression in the prostate, and systemic (metastatic) cancer progression.

These exit points are chosen depending upon what your goal is. It is very important to determine what your overall goal is for watchful waiting. Your possible goals may be:

1. Remain on iWW for a short time period to postpone treatment, evaluate options, or evaluate how fast the cancer is growing.
2. Remain on iWW until there is evidence of cancer progression.
3. Remain on iWW until markers reach what you consider to be dangerous levels, indicating that the cancer may soon spread systemically if not treated.
4. Remain on iWW until systemic metastases occur.
5. Remain on iWW until systemic symptoms appear or worsen.
6. Remain on iWW until health is in jeopardy.

Your goal may be different then this. Whatever it is, write it down. These goals are listed in order of seriousness. Generally, if you choose #2 as your goal, you would probably also want to exit iWW if you experienced #3, #4, #5, or #6.

The first rule of PSA measurements is that they can fluctuate over a 24 hour period. This fluctuation may be as high as +/- 30%. Two common causes of PSA fluctuation are sexual activity or prostate inflammation. Medically induced causes of PSA fluctuation include digital rectal exams, and prostate ultrasounds and biopsies. Also, PSA measurements done in different labs may also be different. What all this means, is that PSA fluctuations of +/- 30% may be within normal variation.

In order to know if the PSA is truly rising, you can either look for a rise in PSA of 50% above baseline, or look for a definite rising trend, such as three successively higher PSA measurements taken at intervals of at least three months apart. These are my recommendations then, to see if PSA is progressing while on PSA:

1. PSA rises to at least 1.5 times the baseline PSA, or,
2. PSA increases on three successive occasions, with measurements taken at least 3 months apart

The baseline PSA is the last PSA you took prior to starting watchful waiting. If you feel that the reading was artificially high or low (due to daily variability), you can pick one of your earlier PSA's as the baseline.

Some patients want to wait until their PSA reaches a "dangerous level" before going on conventional therapy. Some people suggest that a PSA level above 10.0 is associated with a higher chance of the cancer being spreading through the body. Many published studies show that prostate cancers with a PSA above 20.0 have a low chance of cure. Unfortunately, there is no well defined value above which the cancer will metastasize. You may wish to choose a value of 10 or 15.

Local Progression can be determined by changes in digital rectal exam (DRE), increasing tumor size or stage on MRI or ultrasound, by the appearance or worsening of symptoms, or by changes on a repeat biopsy.

A digital rectal examination is very subjective. Physicians will have varied skill levels, and there can be differences in opinion about whether there is a nodule present, its size, and whether it extends beyond the prostate. Even with the same physician checking your prostate on a regular basis, he may have difficulties determining if a nodule is getting bigger or smaller unless there are significant changes. The only semi-accurate way to tell if a tumor is enlarging or shrinking is to 1) preferably have the same physician check it regularly, and 2) consider a change in stage as being a significant change. A change in size of the nodule alone should be looked at as a much softer indication. Have your physician tell you what current tumor stage your prostate tumor is at each time he examines you (i.e T1c, T2a, T2b, T3a, etc.), and how large the nodule is.

This is a more objective measure way to determine progression than a DRE. If the tumor can be seen clearly on a scan then it can be measured. Each of the three diameters, x, y, and z can be measured in centimeters, and the volume of the tumor nodule (in cubic centimeters) can be estimated by multiplying 0.52 * x * y * z. There can be some slight variations in tumor measurements, and I would consider a 50% increase or decrease in tumor volume as being a significant change. As well, scans can suggest if the tumor is directly against the prostate capsule, is extending through it , or is extending up into a seminal vesicle.

Symptoms related to the prostate gland and surrounding tissues can include problems urinating, blood in the urine or semen, pain, and potency problems. These symptoms can be caused by both benign conditions or by tumor growth. The AUA urinary symptom score gives a numeric value of 0 to 35 which indicates the amount of urine obstruction symptoms. It is possible to calculate your AUA score once every several months.

While I am not a big advocate of repeating biopsies, it is an option for monitoring cancer status while following watchful waiting. The first problem with biopsies is that they are painful, and may cause infections, bleeding, or even nerve damage. As well, biopsies may (rarely) cause cancer cell spread along the biopsy needle tract.

The second problem is that pathology biopsies and reports can be subjective. If a repeat biopsy comes back as "negative" while on WW, this probably does not mean that the cancer was spontaneously cured, but usually means that the biopsies missed the tumor in the prostate gland. Multiple biopsy cores are usually taken of the prostate gland and a certain percentage of the cores will contain cancer. That percentage can go up or down merely by chance, depending on where the needle biopsies cores were taken in the gland. Using this percentage may not be a reliable way to assess if the cancer is progressing.

Another feature reported is the Gleason score, which is a value that ranges from 2 to 10 and indicates how aggressive the cancer looks under the microscope, 2 being the best, 6 being the most common, and 10 being the worst. This is also known as the cancer grade. Pathologists often disagree on the Gleason score of a particular tumor, and different pathologists will frequently label the same tumor different values. To improve accuracy, you can have the same pathologist review the previous pathology slides along with the current biopsy, and have him report whether he thinks the Gleason score (and amount of cancer) has increased or decreased. As well, there can also be some random variation in the grade depending on where the biopsies were taken from in the prostate gland.

For the actual biopsy process, it is best if the urologist or radiologist doing the biopsy takes 6 to 12 cores from the prostate, and puts them in at least 6 separately labeled bottles, which indicate which part of the prostate gland the biopsies came from. The pathologist should do a detailed report. From this information you should be able to determine: 1. The maximum Gleason score obtained in the biopsy. 2. The percentage of biopsy cores which contain cancer. 3. Whether the cancer is on the right, left, or both sides. 3. Any other information you feel is pertinent for monitoring your progress.

Prostate cancer has an affinity for spreading to the bones. A bonescan is usually the best way for detecting new cancer in the bones, or a progressions of that cancer.

A CT scan or MRI scan of the pelvis +/- abdomen can be used to see if the lymph nodes are growing in size, which would suggest that cancer is growing in those lymph nodes. These scans will miss small amounts of cancer in the lymph nodes. An MRI of the prostate + pelvis can provide useful information about the tumor size in the prostate, and the status of the pelvic lymph nodes. Alternatively, a Prostascint scan (which takes 5 days to do) can show cancerous lymph nodes throughout the body more accurately than a CT or MRI.

If your goal is to remain on iWW for a short time period before seeking conventional therapy

• Determine why you need this delay (other commitments, to evaluate options, to evaluate cancer growth rate)
• Estimate a time period during which you'll follow iWW, for example 6 or 12 months.
• Watch for any signs of cancer progression while you are on iWW with PSA and DRE.

If your goal is to remain on iWW until there is evidence of Cancer Progression

• PSA rises on 3 sequential occasions, with each measurement separated by 3 months or longer.
• PSA increases to 1.5 times the baseline PSA.
• DRE shows that the cancer has increased its tumor stage.
• Prostate tumor measurements on MRI or ultrasound show that the tumor volume has increased to 1.5 times its baseline volume.
• Urination is becoming significantly worse in conjunction with an enlarging tumor on DRE or a rising trend in the PSA.
• Scans show new or increasing bone or lymph node metastases.

If your goal is to remain on iWW until markers reach a dangerous level at which the cancer may spread systemically

• PSA reaches a value of 10 (or 15)
• DRE worsens to stage T2b (on both sides of prostate)

If your goal is to remain on iWW until systemic metastases appear

• Bonescan shows new hot spots in the bones
• CT, MRI, PET, or Prostascint scan shows new metastases in the bone, lymph nodes, or other organs.

If your goal is to remain on iWW until systemic symptoms appear

• This can be risky, and may result in paralysis or death. It is safer and probably better to start hormonal therapy once cancer is found in the lymph nodes or bones.
• Stop iWW if increasing pain develops in the legs, hips, back, or other bones which are in the same areas as hot spots on the bonescan.
• Tumors in the spine may compress nerves or the spinal cord, resulting in pain, leg weakness, areas of numbness, loss of urinary or bowel control, or even paralysis.
• If there is cancer in the spine while following watchful waiting, you should do an MRI of the spine every 3 months to reduce the chance of spinal cord compression and paralysis.
• Swelling (edema) developing in the legs may indicate lymph node enlargement in the pelvis.

If your goal is to remain on iWW until health is in jeopardy

• This is a risky approach which may result in paralysis or death. If there is cancer in the spine, you should do an MRI of the spine every 3 months to reduce the chance of spinal cord compression and paralysis.
• Exit iWW if there are dangerous appearing tumors in the spine or in a femur leg bone.
• Symptoms of nerve or spinal cord compression.
• Unexpected weight loss of 10 lbs.
• Blood counts are significantly dropping. For instance, hemoglobin (found in red blood cells) has decreased to 10 - 12.