Hannah Clarke

Patient recruitment for the phase 2 trial is expected to begin by the end of 2024.

With this designation, the development process for 9MW2821 can benefit from prioritized engagement with China’s Center for Drug Evaluation as well as expedited review and approval.

The phase 1/2 trial is assessing the safety, tolerability, radiation dosimetry, and preliminary anti-tumor activity of 225Ac-rhPSMA-10.1 in men with mCRPC.

"We propose a new classification system, which we believe will provide a more consistent and standardized approach to classification and treatment of PD," says Landon Trost, MD.

The median PFS with PSMA PET/CT-guided MDT was 33.2 months, vs 13.8 months with choline PET/CT-guided MDT.

Data from the study showed that 45% of biopsies with benign results or low-grade cancers could be reduced overall by using Stockholm3 compared with PSA.

“Our data suggest that an MRI can show suspicious lesions based on size and markers of tumor aggression, which may help doctors differentiate a treatment path for these patients," says Kiran R. Nandalur, MD.

The prognostic test has now been validated in patients who have undergone active surveillance, radiation therapy, or had a radical prostatectomy.

In preclinical studies, META-001-PH demonstrated the ability to reduce urinary oxalate excretion by up to 80%.

Telix must resubmit the BLA with remediations in order to advance the application to full review, which the company expects to be able to complete within approximately 90 days.

“So, rather than waiting for men to proactively seek out mental health supports once they’ve been diagnosed with prostate cancer, we should be offering supports at the time of diagnosis and throughout treatment," says Kerri Beckmann, PhD.

Aspargo plans to file a new drug application with the FDA to support regulatory approval of ASP-001 for erectile dysfunction in the United States.

The grants will support research evaluating ATAD2 in advanced prostate cancer and 6MP in hereditary leiomyomatosis and renal cell cancer.

The CPT code 76377 may be used for ProstatID when the software is used in conjunction with a suitable CT, MRI, or a transrectal ultrasound.

A decision on the NDS for testosterone undecanoate is expected in Q2 of 2025.

Data showed a patient-level detection rate of 93% with flotufolastat F 18 in African American patients.

Data showed that Hispanic patients were consistently underrepresented in clinical trials, while Black participants tended to be overrepresented.

“This highlights a need for physicians to better integrate patient preferences into their treatment recommendations," says Jonathan Bergman, MD, MPH.

The CHMP’s positive recommendation is based on findings from the first interim analysis of the phase 3 EV-302 trial.

"Receiving the new CPT code and national payment rate for Unfold AI is an important development in making advanced personalized prostate cancer care accessible to more patients," said Brit Berry-Pusey, PhD.

The PDUFA goal date for TLX007-CDx is March 24, 2025.

Data from phase 2 of the SANS-UUI trial are expected to support an application to the FDA for approval of the device in patients with urge urinary incontinence.

"This is an exciting step in the evolution of urological surgery for both adult and pediatric patients,” says Chester J. Koh, MD, MBA, FACS, FAAP.

"We will be looking not only at how well this software performs in a busy clinical setting and whether diagnostic accuracy and efficiency improves, but also assessing the experience of clinicians and patients, and looking at the impact on workflow," says Clare Verrill, BM, FRCPath, MMedEd.

The study has enrolled 8 patients to assess the safety and efficacy of the device in sealed vasectomy procedures.

"While the addition of an ICI to low dose FOTIVDA did not improve PFS outcomes after prior ICI, we consider the control arm data an important, evidence-based and clinically meaningful contribution to the oncology community treating relapsed or refractory advanced RCC following front-line ICI combinations," says Michael P. Bailey.

here was a higher concordance of somatic alterations between tissue and ctDNA testing in patients with metastases vs those without.

ORIC-944 was initially being evaluated as a monotherapy in the phase 1b trial.

Topline results from the phase 3 ARANOTE trial showed a statistically and clinically significant improvement in rPFS with the addition of darolutamide to ADT vs ADT alone.

Data showed a 90.6% rate of correct consumer self-selection among those who used the Web App Technology with the DFL vs 57.3% among those that used the DFL alone.