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A Situation only You can Fix

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This week ,  I’m writing directly to you because we have a situation that only you can fix.   We survive on donations averaging about $75. Only a tiny portion of our readers give. If everyone reading this right now gave $7, our fundraiser would be done within a day. That’s right, the price of a sandwich from each of you is all we need. We’re a small non-profit with the costs of a top website: servers, developers, research and programs. Malecare’s Advanced Prostate Cancer program is something special.  If Malecare and our Advanced Prostate Cancer program is useful to you, take one minute to keep it online.  We do our best to keep you alive…please donate to keep us alive.  Please click on the “Donate” button, on the right, or go to and become a donor.  Thank you.
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Normally I don’t write about pre-clinical things unless they are particularly interesting. You guessed it; I found a preclinical item that is interesting.

According to a recent published study by Richard Pestell, M.D., Ph.D., MBA, Director of the Sidney Kimmel Cancer Center at Thomas Jefferson University the receptor CCR5, which is targeted by already approved HIV drugs that are on the market is also key in the driving of prostate cancer metastases. This suggests that by blocking this receptor we might also slow prostate cancer spread.

The study published online in the journal Cancer Research, researchers show that the receptor CCR5 best known for its role in HIV therapy may also be involved in driving the spread of prostate cancer to the bone, the most common site for prostate cancer spread.

“Because this work shows we can dramatically reduce metastasis in pre-clinical models, and because the drug is already FDA approved for HIV treatment we may be able to test soon whether this drug can block metastasis in patients with prostate cancer,” said Pestel, the senior author of the study.
This study builds on previous research from Dr. Pestell’s lab that showed that CCR5 signaling was key in the spread of aggressive forms of breast cancer to the lungs. Given that prostate cancer cells were attracted to the bone and brain, Pestell’s team investigated whether CCR5 could play a role in prostate cancer metastases as well.

They found that CCR5 was more highly expressed in prostate cancer tissue compared with normal tissue, and even more highly expressed in metastases compared with primary tumors. “In fact, we noticed that patients who had a lower expression of the CCR5-pathway genes had a longer survival time, whereas high expression of these CCR5 genes was associated with a shorter overall survival,” said co-first author Xuanmao Jiao, Ph.D., and an instructor in the department of Cancer Biology at Jefferson.
They concluded that CCR5 can play a role in the progression of prostate cancer and that it might be possible to use already FDA approved drugs that target CCR5 to treat advanced prostate cancer. If it can be demonstrated that controlling this pathway slows down prostate cancer metastases, given that these drugs have already passed muster with the FDA their use in treating prostate cancer can be comparatively quick.

Joel T. Nowak, M.A., M.S.W.

As of January 1, 2015 there will be some significant changes in the billing and reimbursement schedule for men receiving Bayer healthcare’s radium Ra223 dichloride (Xofigo). Xofigo is FDA approved for the treatment of men with castration-resistant metastatic prostate cancer (mCRPC) who have symptomatic bone metastases and no known visceral metastatic disease. These changes result from the following determinations from the Centers for Medicare & Medicaid Services (CMS).

• CMS has assigned a new permanent Healthcare Common Procedure Coding System (HCPCS) code to Xofigo. This code, A9606 (Radium ra-233 dichloride, therapeutic, per microcurie) will become effective this January 1, 2015. The code is mandated by CMS and is specifically designed to facilitate automated billing and reimbursement by the doctors and hospitals.

• Prior to the assignment of this code Xofigo was purchased and reimbursed at a flat patient ready dose (PRD), which meant that all patients paid the same no matter how much drug they received (Xofigo doses are calculated based upon a patients weight with heavier patients requiring more drug). Under the new CMS-mandated microcurie A-code, A9606, providers will have to purchase Xofigo and bill payers (insurance companies and patients without insurance) based on the number of microcuries administered (the amount of drug) to each patient, rather than per patient ready dose.

Bayer has indicated that for the average man the cost will not change. For men who are smaller their actual cost will decline and for heavier men their cost will increase.

Bayer has assured Malecare that it is committed to supporting patient access to Xofigo through its support programs for eligible uninsured and underinsured men. It also will continue its program to assist qualified men in meeting their co-insurance obligations.

If you need financial assistance in paying for Xofigo now or after January 1, 2015 you should contact Xofigo Access Services at 1-855-696-3446.

Joel T. Nowak, M.A., M.S.W.

Doctors are not trained to communicate with patients. Now, with the onset of electronic medical records this problem has become worse. Many of them hardly even look their patient in the eyes; instead their faces are often buried in the computer screen and not on us.

Since they don’t really know us, they stumble around, often awkwardly, unable to give us the difficult information we need to know and then run out of the examining room. Not knowing who we are means that they can not help us make decisions, they can not support us in our tough often life and death decisions about what drugs, treatments and settings we want to use in our fight. To often they don’t know what we want and what is important to us, especially as we approach the end of our life.

Many doctors struggle to tell us we have some serious disease, like advanced prostate cancer. They are also uncomfortable and simply terrible at talking to us about our death, which simply is the ultimate result of life.

A good doctor gets to know and understand the thoughts, desires and life concerns of their patients. As hard as this might be there are some simple ways that would help a doctor overcome their barriers, their fears and let them get to know their patients.

Good doctor to patient communication can be very successful with a doctor asking four simple questions and then allowing the conversation to go as it develops:

1- What is your understanding of your health or condition?

2- What would be your goals if your health worsens?

3- What are your fears?

4- What are the trade-offs you would be willing to make and not willing to make?

Repeating these questions, actually conversations, again and again will, over time allow your or doctors to really get to know our wishes and desires. Each interview will yield different answers because the answers to these questions will change for us as our needs change, our concerns change and our disease progresses. These conversations will allow a doctor to get to know how you think and what is important to you. Knowledge like this will allow a doctor to respect and support you and your priorities.

Joel T. Nowak, M.A., M.S.W.

Recently there have been a number of conversations in the prostate media around the topic of treating oligometastatic prostate cancer with a curative goal. Oligometastatic prostate cancer describes the disease state where primary treatment has failed as evidenced by an increasing PSA along with scanning evidence of a limited number of lymph nodes involved in and near to the prostate bed.

Because of the development of better scanning technology and scanning contrasts more oligometastatic disease has been identified and so the conversation escalated about their treatment.

The most commonly discussed treatments have involved radiation therapy. In a presentation at the recent meeting of the Society of Urologic Oncology (SUO) Dr. Jeffrey Karnes discussed the possible role of surgery to treat men with oligometastatic disease.

Dr. Carnes confirmed the well-known fact that 33% of men who have primary treatment will ultimately experience a biochemical recurrence, which can be indicative of local or distant relapse. He said that the recently approved scanning technology, C-Choline PET is a useful tool in identifying the specific location of disease and that it has been incorporated in NCCN’s 2014 guidelines. He also confirmed that men with nodal-only metastases have a more favorable prognosis than those with bony or visceral metastases, the hallmark of oligometastatic disease.

Historically, the standard of care for men with oligometastatic disease is hormone therapy (ADT). ADT is not curative and comes with a host of significant side effects. Dr. Karnes pointed out that ADT is associated with much toxicity, negative quality of life changes and the risk that nodal metastases may harbor castration resistant disease.

He posed the fundamental question, can we cure metastatic prostate cancer? Toujer and colleagues demonstrated good survival outcomes in men with oligometastatic disease without hormones, with those having Gleason that is less than 8, negative margins, and fewer than 2 lymph nodes positive having the longest biochemical recurrence-free survival.

Dr. Karnes then reported his initial use of salvage lymph node dissection (surgery not radiation) performed in 2007 on a 60-year-old man who had received as his primary treatment high-dose brachytherapy, with recurrence in a single obturator lymph node. He reported that this man is alive today and has PSA less than 0.2, to date.

This launched the Mayo Clinic series of salvage lymph node dissections, which includes 52 cases, where all men had a radical prostatectomy in the past.

At a median follow-up of 20 months, 24 men had no further therapy, 18 did start ADT, and 10 had multimodal therapy. Twenty-nine patients had PSA less than 0.2, while 8 had biochemical recurrence after PSA originally became less than 0.2. Median time to biochemical recurrence after salvage node dissection was 438 days.

Dr. Karnes acknowledged that there are limitations to his study which include a heterogeneous treatment sample, a short follow-up, selection bias, along with the lack of a comparable control group. However, he concluded that at this time, salvage node dissection remains a valid treatment option in well-selected patients, and that this novel treatment deserves further study. Optimal patients have not been defined, but likely include those with low PSA, pelvic-only lesions, Gleason score less than 8, and longer interval to a recurrence.

Joel T. Nowak, M.A., M.S.W.

On Dec 2, 2014 Astellas Pharma Europe Ltd announced that the European Commission (EC) has granted a variation that amends their marketing authorization for enzalutamide (Xtandi). Based on this amended authorization Xtandi is now approved in Europe for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated.

Europe now joins the United States in allowing Xtandi to be given to men who have not yet had chemotherapy.

The rationales for this amendment are derived from the pivotal phase III PREVAIL study that demonstrated that Xtandi improved outcomes for men with advanced prostate cancer who have not received chemotherapy. These findings were:

• significantly reduced the risk of radiographic progression or death by 81% compared with placebo.

• Enzalutamide demonstrated a significant impact on overall survival compared to placebo.

• Men treated with enzalutamide experienced a 17-month delay in the time to initiation of chemotherapy compared to placebo.

“Enzalutamide provides a viable treatment option for a broad population of men with mCRPC, regardless of age, or their readiness for chemotherapy, which provides a meaningful period of time during which men have their disease controlled without the need for chemotherapy”, said Professor Bertrand Tombal, MD, PhD, Chairman of the Division of Urology and Professor of Physiology, Université Catholique de Louvain (UCL) and European Principal Investigator for PREVAIL. “The decision from the European Commission to approve enzalutamide, an effective and well tolerated alternative to chemotherapy, is a very important milestone for men with prostate cancer that has advanced.”

Astellas has indicated that they intend to launch Xtandi in the chemotherapy-naïve setting in the first European countries, including the UK beginning December 2014.

Joel T. Nowak, M.A., M.S.W.