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How has Xofigo shutdown affected you?

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Its day 19 since Xofigo production stopped. Malecare continues to dig deep, trying to learn when production might start up again.
Meanwhile, How are you? Please email Joel at about how the Xofigo shutdown has affected your life.

Categories : Uncategorized, Xofigo
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It would be of great advantage to us if we were able to improve the early detection of responders to salvage external beam radiotherapy (RT) after failed radical prostatectomy (RP). Early detection would allow us to make earlier treatment decisions which should provide for better results.
In an attempt to better improve our understanding of early detection, between 2002 and 2007, at a single institution, 136 consecutive men received salvage radiation treatment (RT) to a dose of 66Gy without androgen-deprivation therapy (ADT) aftera prostatectomy (surgery) for a rising prostate-specific antigen (PSA) level. PSA measurements were systematically performed before radiation therapy at the fifth week of radiotherapy, and in the follow-up at least twice a year (every 6mo).

The median follow-up was 60 months. The 5-year freedom from biochemical and clinical failure rates were 57% (95% CI: 48%-66%) and 92% (95% CI: 87%-97%), respectively. The mean PSA5 was 0.61ng/ml (range: 0-7) and the mean PSA ratio was 0.67 (0-1.7). A PSA ratio< 1 was a significant prognostic factor in multivariate analysis for both definitions of biochemical failure (P = 0.01 for both) and for clinical failure (P = 0.005).

For men undergoing salvage radiotherapy, without ADT after surgery with a rising PSA level, the absence of PSA decline during radiation therapy is predictive of biochemical and clinical failure and may be used to rapidly identify poor responders.

Reference: Urol Oncol. 2014 Aug 28. pii: S1078-1439(14)00277-4.
doi: 10.1016/j.urolonc.2014.07.020; Gustave Roussy,

PMID: 25176583

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

The good news for us is that the survival of men diagnosed with prostate cancer has improved over time. The current 10-year relative survival rate is 99.7%! However, the long survival of men who have prostate cancer raises questions about their risk of a second primary cancer and the need for continued surveillance.

A very large population-based cohort of 441,504 men diagnosed with prostate cancer between 1992 and 2010 was identified from the Surveillance, Epidemiology and End Results Program (SEER) data (SEER13). The standardized incidence ratio (SIR) was calculated as an estimate of the risk of a second primary cancers (malignancy) based on the incidence in the general population.

The analysis of the data showed that men who survived prostate cancer had a lower risk of being diagnosed with another cancer overall compared with the US population. The risks of leukemia and cancers of the oral cavity and pharynx, esophagus, stomach, colon and rectum, liver, gallbladder, pancreas, lung and bronchus, and larynx were significantly lower.

However, prostate cancer survivors had a greater risk of developing bladder, kidney, and endocrine and soft tissue cancers.

Men who received treatment with radiation therapy (external-beam radiation therapy) had long-term increases in their risk of bladder cancer and rectal cancer risk compared with who did not receive radiation.

It was also found that there were significant racial differences in the risk of being diagnosed with a second primary cancer, and the magnitude and direction of these risks depended on tumor type.

Prostate cancer survivors remain at risk of subsequent cancers, particularly bladder kidney, endocrine and soft tissue cancers. Additionally, race and treatment choice plays an important role for long-term risk.

Prostate cancer survivors must remain vigilant in monitoring themselves as they are at an increased risk for certain second primary cancers.

Cancer. 2014 Sep 1;120(17):2735-41. doi: 10.1002/cncr.28769. Epub 2014 May 19. Davis EJ1, Beebe-Dimmer JL, Yee CL, Cooney KA.

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


Why You Must Get Provenge Now

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A recent announcement stated that Dendreon’s immunotherapy Provenge (sipuleucel-T) is too expensive to be used as a treatment for advanced prostate cancer under the National Health Service in England.

In preliminary draft guidelines out this morning, the National Institute for Health and Care Excellence has rejected the drug’s use to treat men with metastatic prostate cancer before they have received chemotherapy.

It is my personal opinion, Dendreon’s economic plans for survival is directly hitched to getting the drug used in Europe where it has been approved by regulators. Given the massive economic woes Dendreon faces, the decision in the UK to not use Provenge can be described only as a major setback which greatly increases the risk that the treatment might soon no longer be available to men with advanced prostate cancer.

I’ve always felt quite frustrated and very unhappy that Dendreon has not been able to flourish so that we could be secure in always having Provenge available as a treatment modality. This guidance issued by the National Health Service is a major blow and increases the risk that Provenge might become unavailable in the very near future.

So what does this mean, I urge each and everyone of you who may qualify to get Provenge NOW as it might not be available in the near future. I hate being a naysayer, I hope I am 100% wrong, but if I am not I urge that you take advantage now while it is still available.

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

Men currently being treated with Xofigo should ask their doctors, today, “What should I do in light of the current shortage of Xofigo?”

In our October 8, 2014 bog post, we cited data from the ALSYMPCA clinical trial for Xofigo, which was given to Malecare during an interview with Joseph Germino, MD, PhD, Vice President of United States Medical Affairs for Bayer HealthCare, LLC. Malecare has removed this data, because we now believe it might provide misleading implications regarding patient outcomes due to delayed Xofigo dose administration. We now feel that there is little understanding about what happens to a man when he stops taking Xofigo, mid course.

According to Dr Germino, in an email dated October 9,
“we don’t have a lot of data yet on patients with delayed doses.”
“I wouldn’t want to leave the impression that the data are stronger than they are – we haven’t studied this in a manner to precisely answer the question. ” stated Dr. Germino.

We are grateful to Dr. Germino for his follow-up with Malecare.

There is much incentive for Bayer to discover the source of the contamination of Xofigo and repair their factory. Until then, no one knows what the effect of this world wide shortage will be. Which is why, we say again, talk to your doctor, today.

A word about worry. Reading today’s post may make you feel worried. We share that feeling with you. Worry feels unpleasant, for sure, but we want you to use your worry as a motivator for action. Call your doctor. And then, afterwards, return to your life, as best as you can. Neither you nor we can visit the Xofigo factory and fix it. We have to rely on Bayer for that. But, you can spit into the face of this setback and enjoy the days that you have, right now. So, two messages for today: Call your doctor and keep enjoying life.

Darryl Mitteldorf, LCSW

Categories : Uncategorized
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