Decipher gets boost in guidelines in molecular genomics derby for testing prostate cancer

Also, NCCN guideline recommends an AI test for first time

By Howard Wolinsky

Sometimes patients with prostate cancer feel lost, especially those in the “gray zone” of very high-volume Grade Group 1, or Gleason 6, and those with lower-volume intermediate-risk prostate cancers, Grade Group 2, or Gleason 3+4.

Should they follow Active Surveillance, or close monitoring? Or should they opt for aggressive treatment with radiation or prostatectomy with a risk for ED or incontinence?

Should they undergo a genomic or somatic test, predicting their risks for aggressive cancers, based on studies of their tumors to determine their risks, to help determine their course of care? And if yes, which of these tests should they take: Veracyte’s Decipher Prostate Genomic Classifier, Myriad’s Prolaris, or Mdxhealth’s OncotypeDx GPS (Genomic Prostate Score)?

Randomized controlled studies comparing the tests are underway so presumably we’ll have answers in the next few years.

Meanwhile, in the molecular testing derby, the National Comprehensive Cancer Network (NCCN), which publishes influential expert-written guidelines on prostate cancer, has some news: NCCN has given an edge to Decipher, a 22-gene prognostic tool used for risk stratification of patients with localized prostate cancer. They upgraded recommendations from last year.

NCCN just gave Decipher a 1B evidence level based on data in the post-biopsy and post-prostatectomy settings in its guidelines using “Simon Criteria,” which assignsan evidence level for clinical biomarkers.

No surprise: Veracyte, Decipher’s manufacturer, issued a news release patting NCCN on the back for a job well done.

“We commend the NCCN panel for their evidence synthesis and expert consensus that has again designated the Decipher Prostate test as the gene expression tool for risk stratification supported by the most clinical evidence across the spectrum of the disease and has uniquely provided clinical guidance that integrates a patient’s Decipher score,” said Elai Davicioni, PhD, Veracyte’s medical director of urology.

(Dr. Daniel Spratt, chairman of radiation oncology University Hospitals, Cleveland.)

Dr. Daniel Spratt, Chairman and Professor of Radiation Oncology at University Hospitals Seidman Cancer Center and Case Western Reserve University, who has researched Decipher, said the new NCCN guideline significantly strengthens the group’s guideline from last year.

Spratt conducted a study published in 2023 that provided the first validation of this biopsy-based gene expression classifier, assessing both its prognostic and predictive value, They used data from a randomized phase 3 of intermediate-risk prostate cancer.

“Decipher improves risk stratification and can aid in treatment decision-making in men with intermediate-risk disease,” wrote researchers.

Spratt, who serves on NCCN’s Prostate Cancer Panel, told me in an email, “This was already present last year in the guidelines, but repeated this year with some additional strength for Decipher.”

He also said: “Prolaris has zero randomized evidence to support its use whereas Decipher has ~11 phase 3 trials validating its use. Prolaris doesn’t seem to really do much in some studies. Oncotype Dx also failed to validate in the Canary PASS active surveillance study.

“Thus, Decipher is the most evidence-based genomic classifier (Prolaris and Oncotype are level 3 whereas Decipher is level 1).”

When asked for comment, a spokesperson for Myriad Genetics, which makes the Prolaris test, pointed me to a letter questioning the value of the Simon Criteria. You can discuss this correspondence and the original explanation of the Simon Criteria in the Journal of the National Cancer Institute with your urologist or friendly neighborhood molecular biologist. Mdxhealth hadn’t responded at press time.

Two key points to the genomic testing dilemma,

Many guys with simple Gleason 6 (Grade Group 1) prostate cancers get genomic tests.

Expert advice? Don’t bother.

In fact, many guys have multiple genomics tests as they go on a shopping spree to get an answer they want. Again, experts advise: Don’t bother.

Dr. Todd Morgan, chief urologist at UMichigan, told me in an interview last year, that men with low-risk GG 1 prostate cancer don’t need to take genomic tests and should just monitor their cancers through an AS program. . And he urges us NOT to shop for favorable test results by taking multiple tests at $2k-plus a crack.

He can’t comment on the latest NCCN guidelines since heleads a randomized study of the three major genomic tests.

He told me before the latest news: “The scores [from competing tests] are pretty darn highly correlated from one test to the next. There are differences, but the scores are pretty well correlated. And if you get two tests, and one's higher and the other lower, you would have no idea what to do with the information.”

Also, Morgan advises those of us with low-risk prostate not to undergo these tests, just for the sake of having one. It’s a waste of money.

Stay tuned.

AI prostate cancer test included in a first in NCCN guidelines

By Howard Wolinsky

NCCN for the first time has included an AI-enabled test, ArteraAI, in its Clinical Practice Guidelines for Prostate Cancer for localized prostate cancer.

The NCCN Guidelines classify the ArteraAI Prostate Test as having Level IB evidence, according to the Simon Criteria (see above). ArteraAI is the first AI-enabled predictive and prognostic test NCCN has recommended for localized prostate cancer

“This recognition by the NCCN Guidelines underscores the importance of incorporating innovative tools like the ArteraAI Prostate Test into clinical practice, enabling clinicians and patients to make more informed decisions and personalize treatment strategies,” ArteraAI Chief Medical Officer Tim Showalter, MD, MPH, said in a news release.

(Dr. Tim Showalter, Chief Medical Officer of ArteraAI.)

(Showalter was a featured speaker in a recent ASPI program on AI: https://aspatients.org/meeting/how-ai-will-decrease-overdiagnosis-and-overtreatment-of-prostate-cancer/)

Additionally, NCCN included Decipher as a Category 2A recommendation, signifying a uniform NCCN consensus on the usefulness of the tool as an option in prostate cancer.

Daniel Spratt, MD, Chair of radiation oncology at University Hospitals in Cleveland, who has researched ArteraAI and serves on the NCCN panel, says his research shows two-thirds of men making the transition from AS to radiation therapy can now avoid ADT (androgen deprivation therapy) and its serious side effects based on test results..

For more on Ai anmd ArteraAI:

AI identifies two kinds of prostate cancer: Possible boon to treatment?

By Howard Wolinsky

British researchers using AI have found a new type of aggressive prostate cancer, which may help in diagnostics and treatment strategies.

The paper, by researchers from the University of Oxford and the University of Manchester, just was published in the scientific publication Cell Genomics.

Using an AI technique called neural networks on prostate cancer samples from 159 patients, the new research found that there were two distinctly different ways that prostate cancer could evolve, terming these "evotypes," reported Forbes.

"Our research demonstrates that prostate tumors evolve along multiple pathways, leading to two distinct disease types," Oxford researcher Dan Woodcock said. "This understanding is pivotal as it allows us to classify tumors based on how the cancer evolves rather than solely on individual gene mutations or expression patterns."

Naomi Elster, director of research at Prostate Cancer Research, said more needs to be known about what the prostate cancer diagnosis actually means.

"We simply don't know enough about what a prostate cancer diagnosis means at present," Elster said. "There are many men who have a disease which is or may become aggressive and being able to treat aggressive disease more effectively is critical.

"But on the other side of the coin are the too many men who live with the side effects of cancer treatment they may never have needed."

Tick-tock: ZERO Prostate Cancer’s Active Surveillance webinar March 12

By Howard Wolinsky

I have a busy day coming on Tuesday.

At 6 a.m. Central, I am running a webinar on medical news reporting, remotely of course, with reporters in Addis Ababa, Ethiopia. I have done similar programs in Uganda and Pakistan.

At 10 a.m. Central, I switch hats and join colleagues to run a webinar for ZERO Prostate Cancer covering Active Surveillance. This is our third year.

Please join us and come with your questions.

It will be at 11 a.m.-12 p.m. Eastern on Tuesday, March 12, 2024. Register:
https://us02web.zoom.us/meeting/register/tZUsfuqgrjIoG9AWf7voMhzT_UjdqbQQbQPA

My stalwart AS support colleagues Jim Schraidt, a ZERO board member and an AnCan moderator, and Hugh Idstein and Garry Tosca from AnCan, will be on deck at this popular session.

ASPI reskeds BPH webinar to March 23, bowing to PCRI mid-year conference

By Howard Wolinsky

Active Surveillance Patients International is rescheduling its webinar “ABCs of BPH” to noon-1:30 p.m. Eastern on March 23 because of an overlap with the mid-year conference of Prostate Cancer Research Institute.

So to get this straight. Register for the ASPI program on March 23—not March 30—here: https://zoom.us/meeting/register/tJYoduChrzIrH9dHBNZXqD_pOUCG85yv_KQF#/registration If you’ve already registered, Zoom will get you straight.

Sign up for the PCRI virtual meeting on March 30 here: https://pcri.org/2024-midyear-update

And don’t forget: Spring ahead on Sunday.

Daylight Saving Time Starts. This Sunday, March 10, 2024, at 2:00:00 a.m., clocks are turned forward one hour to Sunday, March 10, 2024, 3:00:00 a.m.

Got it? Change your calendars and clocks accordingly. You’re on your own now.