UCLA, UCSF obtain FDA approval for PSMA PET imaging in men with prostate cancer



The University of California’s two nationally ranked medical centers, UCSF and UCLA, and their nuclear medicine teams have obtained approval from the U.S. Food and Drug Administration to offer a new imaging technique for prostate cancer that locates cancer lesions in the pelvic area and other parts of the body to which the tumors have migrated.

Known as prostate-specific membrane antigen PET imaging, or PSMA PET, the technique uses positron emission tomography in conjunction with a PET-sensitive drug that is highly effective in detecting prostate cancer throughout the body so that it can be better and more selectively treated. The PSMA PET scan also identifies cancer that is often missed by current standard-of-care imaging techniques.

UCLA and UCSF researchers studied PSMA PET to provide a more effective imaging test for men who have prostate cancer. Because the PSMA PET scan has proven to be more effective in locating these tumors, it should become the new standard of care for men who have prostate cancer, for initial staging or localization of recurrence.”


Dr. Jeremie Calais, Assistant Professor, David Geffen School of Medicine, UCLA

A clinical trial conducted by the UCSF and UCLA research teams on the effectiveness of PSMA PET proved pivotal in garnering FDA approval for the technique at both universities. The PSMA drug used in the technique was developed outside the U.S. by the University of Heidelberg.

“It is rare for academic institutions to obtain FDA approval of a drug, and this unique collaboration has led to what is one of the first co-approvals of a drug at two institutions,” said Dr. Thomas Hope, an associate professor at UCSF. “We hope that this first step will lead to a more widespread availability of this imaging test to men with prostate cancer throughout the country.”

How it works

For men who are initially diagnosed with prostate cancer or who were previously treated but who have experienced a recurrence, a critical first step is to understand the extent of the cancer. Physicians use medical imaging to locate cancer cells so they can be treated.

PSMA PET works using a radioactive tracer drug called 68Ga-PSMA-11, which is injected into the body and attaches to proteins known as prostate-specific membrane antigens. Because prostate cancer tumors overexpress these proteins on their surface, the tracer enables physicians to pinpoint their location.

The current standard of care in prostate imaging is a technique called fluciclovine PET, which involves injecting patients with fluciclovine, a synthetic radioactive amino acid. Since prostate cancers consume more amino acids than normal prostate cells, the tumors accumulate large amounts of the synthetic tracer, making them easier to detect during scans.

In their research comparing PSMA PET and fluciclovine PET, the UCLA and UCSF research teams found that imaging with PSMA PET was able to detect significantly more prostate lesions than fluciclovine PET in men who had undergone a radical prostatectomy but had experienced a recurrence of their cancer. Their findings indicate that PSMA PET should be strongly considered both before initial treatment in men with high-risk cancers and in cases of cancer recurrence after surgery or radiation to provide more precise care. The PSMA tracer also can be used in conjunction with CT or MRI scans.

UCSF and UCLA are the only two medical centers in the U.S. that can offer PSMA PET to the public through this FDA approval. A limited number of other U.S. medical centers are currently using PSMA as an investigational technique, generally as part of a clinical trial. However, more hospitals will have the opportunity to adopt the technology after applying for expedited FDA approval, which is now possible as a result of the initial FDA approval gained by UCLA and UCSF.

“I believe PSMA PET imaging in men with prostate cancer is a game changer because its use will lead to better, more efficient and precise care,” said Dr. Peter Carroll, a professor at the UCSF Helen Diller Family Comprehensive Cancer Center.

“Prostate cancer is one of the most common cancers in men, with more than 190,000 newly diagnosed cases expected just this year alone,” said Dr. Johannes Czernin, chief of the Ahmanson Translational Theranostics Division at UCLA. “That’s why this major effort between the UCLA and UCSF nuclear medicine divisions and our many partners was important and will significantly change for the better how this cancer is detected and treated.”

The UCLA research team was led by the nuclear medicine faculty from the molecular and medical pharmacology department’s Ahmanson Translational Theranostics Division. They worked in collaboration with the departments of urology, radiation oncology and radiology, along with support from the Geffen School of Medicine, the UCLA Jonsson Comprehensive Cancer Center and the Prostate Cancer Foundation.

The UCSF research team was led by faculty from the molecular imaging and therapeutics section of the department of radiology and biomedical imaging, who worked in collaboration with the departments of urology, radiation oncology and medical oncology. Support was provided by the UCSF Helen Diller Family Comprehensive Cancer Center and a philanthropic gift to the UCSF Department of Urology, and by the Prostate Cancer Foundation.

“‘Game changer’ is almost an understatement for how prostate cancer patient care could be improved by this technique,” said Dr. Jonathan W. Simons, CEO of the Prostate Cancer Foundation. “After investing more than $26 million in research on PSMA over many years, we are honored to congratulate the research teams at UCSF and UCLA on their milestone achievement.”


When David McEowen discovered he had a recurrence of prostate cancer, his physicians used PSMA PET as part of his treatment plan. Today, he is cancer-free.

Source:

University of California – Los Angeles Health Sciences



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SC officials say they can’t obtain drugs by Friday execution


COLUMBIA, S.C. (AP) — South Carolina prison officials say they have to delay an execution scheduled for Friday because they won’t be able to obtain the necessary lethal injection drugs.

An attorney for the state Department of Corrections wrote in a letter to the South Carolina Supreme Court last week that the agency cannot carry out the execution of Richard Bernard Moore due to the lack of drugs, which it has not had stocked since 2013. The Associated Press obtained a copy of the letter.

The court scheduled Moore’s execution after he exhausted his federal appeals this month. Moore, 55, has spent nearly two decades on death row following his conviction for the 1999 killing of a convenience store clerk in Spartanburg County. He would be the first person executed in South Carolina in nearly a decade.

The state’s usual injection protocol calls for three drugs: pentobarbital, pancuronium bromide and potassium chloride. But the corrections agency has said it has not had the drugs in stock since 2013, when its last supplies expired. The agency has previously said it reserves the right to execute Moore with a single lethal dose of the sedative pentobarbital.

Lindsey Vann, one of Moore’s attorneys, called the delay “unprecedented” on Monday, adding that she wasn’t aware of any other execution in South Carolina history requiring such a delay due to a lack of drugs.

In 2017, corrections officials said they could not carry out the execution order of Bobby Wayne Stone without the appropriate drugs. At the time, however, Stone had not yet exhausted his appeals in court.

Prison officials say that per state law, Moore must be executed by lethal injection by default because he did not choose between lethal injection and electrocution by a deadline earlier this month. Moore’s attorneys say he did not make a decision because the agency is not being transparent with its execution protocols.

Moore’s legal team is also seeking to block the execution in federal court.

Securing lethal injection drugs has become an increasingly difficult task in the U.S. as drug manufacturers have shied away from selling to states under pressure from anti-death penalty activists. Corrections chief Bryan Stirling, along with the governor and attorney general, have advocated for a bill to shield the identities of manufacturers who provide such drugs.

State lawmakers have also mulled in recent years a bill to require death row prisoners to die by electric chair if lethal injection is not available.

Moore is one of 37 people, all men, currently on South Carolina’s death row. Some prosecutors have sought the death penalty less often in recent years, citing the state’s inability to carry out executions.

South Carolina’s last execution was in 2011.

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This version of the story corrects that the deadline for Moore to choose was this month, not last month.

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Michelle Liu is a corps member for the Associated Press/Report for America Statehouse News Initiative. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues.



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RYDE program helps disadvantaged youth obtain driver’s licence


Jonathon Akers should be enjoying all that comes with having his driver’s licence, but instead he is one of hundreds of disadvantaged youth struggling to get on the road.

The 19-year-old lives in crisis accommodation in Bunbury, 180 kilometres south of Perth, with no family support.

With no-one to teach him how to drive, he cannot complete the 50 hours of supervised driving required in Western Australia, and has no job to pay for a licence.

“I never had the money or the benefits just sitting there to pay for my licence,” Mr Akers said.

Less fortunate face tough journey

Hundreds of young people – and adults – from disadvantaged backgrounds are in the same predicament.

But a program developed by the Town of Bassendean eight years ago that has seen success in addressing the problem is now rolling out across regional WA.

Regional Youth Driver Education (RYDE) was designed for 16-to-24-year-olds whose personal and financial circumstances were stopping them from getting a licence.

The not-for-profit program offers a car and a qualified driver who volunteers their time to help people build up logbook hours for a small fee.

A further extension of the program unique to the South West, End-to-End, is a complete wrap-around service for more disadvantaged people, giving them free driving lessons and financial support to obtain their licence.

South West program manager Semara Murphy says young drivers often give up on the idea of ever driving, or get behind the wheel illegally.(ABC South West: Zoe Keenan)

‘They end up giving up’

Semara Murphy, who runs RYDE in the South West, said the process of getting a licence had inadvertently been made harder for less fortunate people.

“A lot of the young people that we see and support don’t have family support around them to help them learn how to drive and build up those hours,” she said.

“This often results in hours being forged and young people getting friends to sign off on hours not being done.

“They will just end up driving without a licence, which a lot of the time kicks off a cycle of people getting in trouble and ending up with a licence suspension.

Roads open up

Since RYDE started in Bunbury late last year the demand for the service has gone through the roof.

As a result, the program is expanding throughout the South West and into the Pilbara.

“We have had an overwhelming response from young people and service organisations, support networks and parents who just don’t have time [to help build up their hours],” Ms Murphy said.

“Watching young people go through the program is incredible — watching them kick goals despite challenges they face in their day to day life.”

Mr Akers said without the program he never could never have hoped to be on the way to getting his licence.

“It’s pretty special,” he said.



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Davinder Singh: Pakistani officials were using suspended J&K cop to obtain sensitive info: NIA | India News


NEW DELHI: The National Investigation Agency on Monday filed a chargesheet against six people, including suspended Deputy Superintendent of Jammu and Kashmir Police Davender Singh, for alleged terror activities in the country, officials said.
The agency said that Singh was in touch with certain officials of the Pakistan High Commission in New Delhi through secure social media platforms. The NIA chargesheet said that Singh was being groomed by the Pakistani officials for the purpose of obtaining sensitive information.
Besides Singh, the chargesheet also names banned Hizbul Mujahideen commander Syed Naveed Mushtaq alias Naveed Babu as well as the group’s alleged overground worker Irfan Shafi Mir and its member Rafi Ahmad Rather. The other two named are Tanveer Ahmad Wani, a trader, and Naveed Babu’s brother Syed Irfan Ahmad, officials said.

In the chargesheet, the NIA said that Pakistan High Commission officials were in constant touch with Irfan Shafi Mir, who claims to be an advocate, and provided him funds to organize anti-national seminars in Jammu & Kashmir.
“Mir also used to receive instructions and money from Pakistan High Commission in New Delhi and also facilitated the visa applications for number of Kashmiris for their visit to Pakistan,” the chargesheet said.
As per chargesheet, the accused were part of a conspiracy hatched by Hizbul Mujahideen and Pakistani state agencies to commit violent acts against India.
The NIA had taken over the terror case on January 18, a week after Singh was caught in south Kashmir while ferrying two terrorists out of the valley on January 11.



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Scientists obtain ‘lucky’ image of Jupiter


Image copyright
Gemini Observatory/M.H.Wong et al

Image caption

It took hundreds of exposures to build this sharp image mosaic of Jupiter in the infrared

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Astronomers have produced a remarkable new image of Jupiter, tracing the glowing regions of warmth that lurk beneath the gas giant’s cloud tops.

The picture was captured in infared by the Gemini North Telescope in Hawaii, and is one of the sharpest observations of the planet ever made from the ground.

To achieve the resolution, scientists used a technique called “lucky imaging” which scrubs out the blurring effect of looking through Earth’s turbulent atmosphere.

This method involves acquiring multiple exposures of the target and only keeping those segments of an image where that turbulence is at a minimum.

When all the “lucky shots” are put together in a mosaic, a clarity emerges that’s beyond just the single exposure.

Infrared is a longer wavelength than the more familiar visible light detected by the likes of the Hubble telescope. It is used to see past the haze and thin clouds at the top of Jupiter’s atmosphere, to give scientists the opportunity to probe deeper into the planet’s internal workings.

Researchers want to understand better what makes and sustains the gas giant’s weather systems, and in particular the great storms that can rage for decades and even centuries.

The study that produced this infrared image was led from the University of California at Berkeley. It was part of a joint programme of observations that involved Hubble and the Juno spacecraft that’s currently orbiting the fifth planet from the Sun.

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Fast facts about Jupiter

  • Jupiter is 11 times wider than Earth and 300 times more massive
  • It takes 12 Earth years to orbit the Sun; a ‘day’ is 10 hours long
  • In composition it resembles a star; it’s mostly hydrogen and helium
  • Under pressure, the hydrogen assumes a state similar to a metal
  • This ‘metallic hydrogen’ could be the source of the magnetic field
  • Most of the visible cloudtops contain ammonia and hydrogen sulphide
  • Jupiter’s low-latitude ‘bands’ play host to very strong east-west winds
  • The Great Red Spot is a giant storm vortex wider than Planet Earth

JupiterImage copyright
NASA/ESA/A.Simon

Image caption

Jupiter as seen in visible wavelengths of light by Hubble

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