‘Hidden’ Prostate Cancer on Biopsy Usually Means Good Outcome: Study | Health News

By Robert Preidt, HealthDay Reporter

(HealthDay)

MONDAY, Nov. 23, 2020 (HealthDay News) — Negative biopsies among early-stage prostate cancer patients who’ve chosen active surveillance are associated with a low risk of disease progression, but they aren’t a sign that their cancer has completely vanished, a new study indicates.

Active surveillance refers to close monitoring for signs of cancer progression — what’s often called “watchful waiting.” Patients sometimes get regular prostate-specific antigen (PSA) testing, prostate exams, imaging and repeat biopsies.

The objective of active surveillance is to avoid or delay treatment and its side effects without putting patients at risk of cancer progression and death.

Sometimes, active surveillance patients have negative biopsies that show no evidence of prostate cancer. While some of these patients may believe that their cancer has “vanished,” they most likely have low-volume or limited, hidden areas of prostate cancer that weren’t detected in the biopsy sample, according to the authors of the study published recently in The Journal of Urology.

“While a negative biopsy is good news, the long-term implications associated with such ‘hidden’ cancers remain unclear,” said study author Dr. Carissa Chu, from the University of California, San Francisco.

For the study, Chu and colleagues analyzed data from 514 men undergoing active surveillance for early-stage prostate cancer between 2000 and 2019. All of them had at least three surveillance biopsies after their initial prostate cancer diagnosis. Median follow-up time was nearly 10 years.

Of those patients, 37% had at least one negative biopsy, including 15% with consecutive negative biopsies, according to the report.

Men with negative biopsies had more favorable disease characteristics, including low PSA density and fewer samples with cancer at the initial prostate biopsy. Negative biopsies were also associated with good long-term outcomes, the researchers said.

After 10 years, rates of survival with no need for prostate cancer treatment (such as surgery or radiation) were 84% for men with consecutive negative biopsies, 74% for those with one negative biopsy and 66% for those with no negative biopsies.

After adjusting for other factors, the researchers concluded that men with one or more negative biopsies were much less likely to have cancer detected on a later biopsy.

“For men undergoing active surveillance, negative biopsies indicate low-volume disease and lower rates of disease progression,” Chu said in a journal news release. “These ‘hidden’ cancers have excellent long-term outcomes and remain ideal for continued active surveillance.”

SOURCE: The Journal of Urology, news release, Nov. 17, 2020

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Mustang Bio Announces Initial Phase 1 Data on MB-105 for Patients with PSCA-positive Castration Resistant Prostate Cancer

Data presented by City of Hope at 27th Annual Prostate Cancer Foundation Scientific Retreat

WORCESTER, Mass., Oct. 26, 2020 (GLOBE NEWSWIRE) — Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced that one patient‘s experience on the Phase 1 trial of MB-105, a prostate stem cell antigen (PSCA) chimeric antigen receptor (CAR) T administered systemically to patients with PSCA-positive metastatic castration-resistant prostate cancer (mCRPC), was presented at the virtual 27th Annual Prostate Cancer Foundation Scientific Retreat.

Tanya Dorff, M.D., City of Hope Associate Clinical Professor, Department of Medical Oncology & Experimental Therapeutics and Head of its Genitourinary Cancer Program and the trial’s principal investigator, presented a description of the correlative science from the ongoing Phase 1 open-label clinical trial of MB-105, one of the first CAR T trials for prostate cancer in the nation. In a 73-year-old male patient with PSCA-positive mCRPC who was treated with MB-105 and lymphodepletion (a standard CAR T pre-conditioning regimen) after failing eight prior therapies, MB-105 demonstrated on day 28 a 94 percent reduction in prostate-specific antigen (PSA), near complete reduction of measurable soft tissue metastasis by computerized tomography, and improvement in bone metastases by magnetic resonance imaging. The therapy was associated with cytokine release syndrome, which was clinically managed with tocilizumab (anti-IL-6 receptor antibody), and hemorrhagic cystitis requiring transfusion which clinically resolved in 30 days.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “We are encouraged by the initial data presented by City of Hope from the ongoing Phase 1 trial of Mustang’s CAR T cell therapy MB-105. We see potential for this PSCA-targeted CAR T in the treatment of prostate cancer, as well as other difficult-to-treat solid tumor cancers. We look forward to the continued progression of this trial and anticipate providing further data in the second half of 2021.”

According to the American Cancer Society (ACS), prostate cancer is the most common cancer in American men, excluding skin cancer. ACS estimates 191,930 new cases of prostate cancer in the U.S. will be diagnosed this year, and roughly one out of every nine men will be diagnosed with prostate cancer during his lifetime. The median survival for men with CRPC is less than two years, according to the American Urological Association.

About MB-105 (PSCA CAR T technology)
MB-105 was developed in the laboratory of Saul Priceman, Ph.D., assistant professor in City of Hope’s Department of Hematology & Hematopoietic Cell Transplantation and associate director of translational sciences in the T Cell Therapeutics Research Laboratory led by Stephen Forman, M.D., leader of City of Hope’s Hematologic Malignancies and Stem Cell Transplantation Institute and the laboratory’s director.

The Phase 1 clinical trial of MB-105 will continue to enroll up to 33 patients. Its primary endpoints are to define safety and optimal dosing of PSCA CAR T cells in treating patients with PSCA-positive mCRPC. Secondary

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Non-Invasive Prostate Cancer Test Boosts Early Treatment


For years, men with an elevated PSA had two options: adopt a wait-and-see approach, or, to find out with certainty whether they had cancer, get a biopsy, a painful procedure where a physician puts a needle through the wall of the rectum and into the prostate. It also carries risk of bleeding or infection.

Instead, Ripken’s urologist, Ronald Tutrone Jr., chief of the Division of Urology at the Greater Baltimore Medical Center, recommended the ExoDx Prostate Test, a newer, simple urine test that looks for genetic changes indicating prostate cancer. When that test came back elevated, Ripken went ahead with a biopsy that indeed revealed he had prostate cancer. He underwent successful surgery in March, and is now in remission.

Ripken feels fortunate his cancer was caught in the early stages, and that he was able to get the ExoDX Prostate Test. “Without it I might have decided to simply watch my PSA levels for a while, and the cancer might have spread.”

For more than thirty years, the PSA has been the gold standard when it comes to detecting prostate cancer. But it’s also had its share of controversy. “There have been concerns that a positive PSA test has led to overdiagnosis and overtreatment,” says James Wysock, M.D., a urologic oncologist and assistant professor of urology at NYU Grossman School of Medicine in New York City. In men with PSA levels in the 4.0 to 10 range, biopsy confirms cancer about 25 percent of the time. This means that the remaining 75 percent would have to undergo a procedure that’s painful, anxiety-producing, and carries risks including infection and bleeding. And even if the test successfully picks up cancer, Wysock adds, many prostate cancers grow so slowly that they will not cause harm during a man’s lifetime. But to be on the safe side, many men opt for treatment, which carries risk of side effects such as incontinence and impotence.

Now, not only can several new blood and urine tests more accurately measure your risk for prostate cancer, they can also detect how aggressive your cancer is, so that both you and your doctor can come up with a targeted treatment. “Not all prostate cancers need to be treated — we can sometimes do what’s known as active surveillance, where you’re monitored over time to see if your levels rise,” explains Wysock.

The ExoDx, which has been available since 2017, works by checking a man’s urine for specific prostate cancer biomarkers that would indicate tumor cell growth. If the test comes back with a score under 15.6, it’s considered low risk or benign. Anything higher could indicate cancer. Ripken’s score was 45.

Similar specific tests to diagnose prostate cancer have been available for close to a decade. Two of the earliest ones were the Prostate Health Index (PHI), FDA approved in 2012, and the 4Kscore test, approved in 2015. These both combine the results of different types of PSA to get an overall score that reflects the chance a man

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