Showing posts with label Testosterone. Show all posts
Showing posts with label Testosterone. Show all posts

December 1, 2016

Man Cured of Bladder Cancer with Testosterone Experimental Therapy


A man with advanced prostate cancer that didn’t seem to be treated has been “cured” by a new experimental therapy.

The new treatment involved shocking tumours to death using testosterone.

Other very ill men involved in the trial saw astonishing results, with tumours being seen to shrink and the progress of the disease stopping in its tracks.

Overall, most of the people involved in the trial seemed to undergo positive results. Scientists tested that by looking at levels of Prostate Specific Antigen (PSA), a blood marker used to monitor prostate cancer – and found that it fell in most of the 47 people involved in the study.

And one individual had so little of the market in his body – and no trace of the disease – that doctors said he appears to be cured after 22 cycles of the treatment.

The trial saw the men complete at least three cycles of what is called bipolar androgen therapy, or BAT. That sees their bodies get flooded with testosterone and then starved of it.

Until now, the male hormone had thought to help spur prostate cancer on. And so scientists have traditionally looked to treat it by cutting off the supply of testosterone.

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But the new study comes off the back of lab experiments that have seen cancer cells get suppressed or even killed by blasts of the same hormone.

Professor Sam Denmeade, from Johns Hopkins University School of Medicine in Baltimore, US, who led the new study, said: "We think the results are unexpected and exciting.

"We are still in the early stages of figuring out how this works and how to incorporate it into the treatment paradigm for prostate cancer.

"Thus far we have observed dramatic PSA response in a subset of men; PSA levels declined in about 40% of men and in about 30% of men levels fell by more than 50%.

"Some men also have objective responses with a decrease in the size of measurable disease, mostly in lymph nodes. Many of the men have stable disease that has not progressed for more than 12 months.

"I think we may have cured one man whose PSA dropped to zero after three months and has remained so now for 22 cycles. His disease has all disappeared."

Early findings from the on-going Restore study were presented at the EORTC-NCI-AACR symposium on Molecular Targets and Cancer Therapeutics in Munich, Germany.

All the patients had spreading cancer that was resistant to treatment with two of the latest hormone therapy drugs, abiraterone and enzalutamide.

The men received high dose injections of testosterone once every 28 days. At the same time, they were given a drug that stopped testosterone being produced naturally by the testicles.

"Our goal is to shock the cancer cells by exposing them rapidly to very high followed by very low levels of testosterone in the blood," said Prof Denmeade.

Six of the men tested positive for a protein called AR-V7 that may be associated with resistance to enzalutamide.

After BAT treatment, no sign of the protein was seen in the blood of all six. Two of the men had declines in PSA level of 50% or more.

The therapy appears to be well-tolerated by the patients, one man experiencing an increase in pain and another having a problem with urine retention.

Prof Denmeade said it was still not clear how the treatment worked, but it appeared to involve cell signalling and part of the process of cell division. Large doses of testosterone also seemed to cause prostate cancer cells to make breaks in their DNA.

Cancer cells stopped dividing and turned "senescent", meaning they "become like old men who sit around and tell stories but don't make much trouble", said the professor.

He cautioned that the therapy was still highly experimental and only suitable for men not suffering painful symptoms.

"Testosterone treatment can definitely worsen pain in men with prostate cancer who have pain from their disease," he said.

A multi-centre randomised US trial called Transformer is now comparing BAT with enzalutamide in men who have become resistant to abiraterone. It aims to recruit a total of 180 participants.

Prof Denmeade said: "If we find testosterone is superior then we would hope to move on to larger trials. Our problem is this is not a drug that is owned by a pharmaceutical company; it is generic testosterone. So moving forward is going to be difficult due to issues with finding funds to run a bigger trial."

Each year around 47,000 men are diagnosed with prostate cancer in the UK and 11,000 die from the disease.

Dr Matt Hobbs, deputy director of research at the charity Prostate Cancer UK, said: "Drugs that reduce the levels of testosterone (androgen deprivation therapy) are an effective treatment for thousands of men with advanced prostate cancer.

"However, at some point the cancer evolves and those drugs stop working. This research is intriguing because it offers a hint that - somewhat unexpectedly - for some men whose cancers have reached that 'hormone-resistant' stage it may be possible to kill or stop growth of the cancer cells by actually overloading them with testosterone.

"Many exciting new lines of attack against prostate cancer are emerging of which this is one.

“However, this is early stage research and further studies are needed in order to understand exactly how intriguing developments like this work and to test the findings more robustly in large clinical trials."

Press Association

March 16, 2015

Go Ahead Take Your Testosterone No Cardiovascular risks but a stronger libido


This  new Study and is a relief to thousands of men of different ages that take Testosterone. This body produced hormone tends to go down as we age but there other causes that we might be showing a low testosterone level. Testosterone will affect everything from your mood and good health to a good performance in bed. Without it we would feel tired all the time and not in the mood to take the initiative on anything we didn’t have too. The absence of it can also put us on a spiraling down depression. However Drs. always warn no to over do it with the fear that it might cause cardiovascular harm, so relax and they your doses as indicated without missing any. Adam Gonzalez, Publisher
Two new studies muddy the waters on the potential cardiovascular risks previously linked to testosterone-replacement therapy in men, with both studies suggesting the therapy might not be causing the cardiovascular harm suggested in previous analyses[1,2]. Both are scheduled for the presentation later this week at the American College of Cardiology (ACC) 2015 Scientific Sessions.
The first study included 7245 men with low testosterone levels from 15 hospitals and 150 clinics. Overall, the cardiovascular event rate—a composite of MI, stroke, or death—was 5.5% among those who received testosterone therapy and 6.7% among those who did not. After adjustment for baseline differences between the treated and untreated patients, the difference in the cardiovascular event rate was not statistically significant.
In the second study, a meta-analysis of 29 studies with more than 122 000 men, researchers found testosterone therapy was not associated with a significantly increased risk of adverse cardiovascular outcomes.
"When we pulled out all the studies so far, testosterone in any form—whether it was a gel, an injection, or older pills—did not increase the risk of cardiovascular events, such as heart attack, sudden cardiac death, stroke, or hospitalization for heart failure," Dr Pawan Patel (Regions Hospital, St Paul, MN), lead investigator of the meta-analysis, told heartwire . "Now, this is a not long-term, prospective, randomized controlled trial. Only with those long-term randomized controlled trials will we be able to say whether testosterone causes cardiovascular events or not."
The FDA Warning
Last week, the US Food and Drug Administration issued a warning about the potential risks of MI and stroke among men treated with testosterone-replacement therapy. The FDA began investigating the link between testosterone therapy and adverse cardiovascular outcomes in January 2014 on the basis of two studies linking the products with increased risks.
In the first study, an observational analysis of Veterans Affairs (VA) patients undergoing coronary angiography, the use of testosterone therapy was associated with a 29% higher risk of death, MI, or ischemic stroke when compared with men who were not receiving testosterone-replacement therapy. In the second study, men treated with testosterone were significantly more likely to have an MI in the first 90 days after starting the medication. Three months after the start of testosterone therapy, the risk of MI overall was increased by 36%. For those aged 65 years and older, the risk of MI was more than twofold higher in the 90 days after filling the prescription.
Those two studies, however, were not the only analyses suggesting a risk of cardiovascular events with testosterone. In the Testosterone in Older Men with Mobility Limitations (TOM) study, testosterone treatment in men aged 65 years and older was associated with an increased risk for cardiovascular events, including MI and hypertension. That study, which was funded by the National Institutes of Health, was stopped because of the cardiovascular risks.
Given the heightened concerns about adverse cardiovascular outcomes with testosterone therapy, the FDA now requires manufacturers of prescription testosterone products to clarify the approved uses of the medications on the product label and add information about the possible increased risk for heart attack and stroke with use of these products. Specifically, the label now states that testosterone-replacement therapy is approved "only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause hypogonadism."
The FDA added it is aware "testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging." The safety and benefits in this setting have not been established, it states. According to IMS Health, sales of prescription testosterone products were more than $2 billion in 2013.
What the New Data Show
The new studies presented this later week at the ACC cast some doubt on those previous concerns. In the first study, Dr Zuber Ali (Aurora Health Care, Milwaukee, WI) and colleagues studied 7245 men, mean age 54 years, prescribed testosterone-replacement therapy for low testosterone (<300 1.78="" 34="" 3="" 41="" acute="" among="" analysis="" and="" at="" cardiovascular="" compared="" death="" dl="" documented="" dyslipidemia="" factors="" follow-up="" font="" having="" hypertension.="" in="" increased="" many="" mean="" mi="" multivariate="" ng="" no="" of="" or="" patients.="" patients="" period="" risk="" stroke="" testosterone-treated="" the="" there="" untreated="" was="" were="" with="" years.="" years="">
Similarly, Patel and colleagues saw no increased risk of cardiovascular events in their meta-analysis. Given the heterogeneity of the studies, they used a random-effect model to calculate the relative risk of testosterone therapy among the patients who received the supplement in their 122 889-patient meta-analysis. Overall, their results suggested testosterone therapy did not increase the risk of adverse cardiovascular events (relative risk 1.168; P=0.431).
To heartwire , Patel said that given the shifting US demographics, with a growing number of older and elderly patients, more and more patients are being prescribed testosterone therapy. Overall, he believes the FDA warning might be premature. His study, as well as the study by the Wisconsin researchers, suggests the risks might be overestimated. However, Patel stressed that a randomized trial is the only way that clinicians and regulatory agencies will get the answers they need about the real risks of testosterone therapy.
Ali and coaouthors report no relevant financial relationships. Patel reports no relevant financial relationships; disclosures for the coauthor are linked to the abstract. The studies were independently funded by their health centers and without industry involvement.

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