August 4th 2025
INKmune was well-tolerated across all 3 dose levels assessed.
"As with all medications and services, it is important to check with the patient’s insurer to determine their policy and whether the medication will be covered," write Jonathan Rubenstein, MD, and Mark Painter.
August 1st 2025
Data showed that 1 in 6 men with GG1 prostate cancer ultimately had higher-risk disease when other clinical features were taken into account.
A recap of the FDA submissions and regulatory decisions in urology from July 2025.
July 31st 2025
Data show that TAR-200 monotherapy led to high complete response rates and encouraging DFS in patients with BCG-unresponsive high-risk NMIBC.
Preclinical data show promise of ATNM-400 for prostate cancer
ATNM-400 demonstrated improved efficacy compared with 177Lu-PSMA-617 in treatment-resistant models as well as enhanced efficacy in combination with enzalutamide.
Trial launches of ABO-101 for primary hyperoxaluria type 1
The first patient has been dosed in the phase 1/2 redePHine trial, evaluating the safety and preliminary efficacy of ABO-101 for PH1.
Enzalutamide shows improved relative efficacy over darolutamide in mHSPC
Enzalutamide plus ADT was associated with significant improvements in rPFS and time to castration resistance compared with darolutamide plus ADT.
Lower dose of abiraterone shows comparable efficacy to standard dose for prostate cancer
The 500 mg regimen of abiraterone acetate demonstrated comparable anti-tumor activity and a favorable safety profile compared with the standard 1000 mg dose.
Pearls & Perspectives: Tailoring BPH Therapies to the Patient, with Utsav Bansal, MD
Bansal unpacks how to personalize treatment plans in a therapeutic landscape now filled with minimally invasive and surgical options.
ThuFLEP and M-HoLEP achieve comparable functional outcomes in BPH
However, M-HoLEP was superior in terms of enucleation time and efficiency, catheterization time, and hospital stay.
Home instillation of mitomycin intravesical solution found feasible, safe in NMIBC
Data from the phase 3b study were recently published in Reviews in Urology, showing that administration of mitomycin intravesical solution in the home setting was feasible, safe, and effective.
Study shows persistent bone protective effect of menopausal hormone therapy
Data showed that fracture risk rises briefly after menopausal hormone therapy discontinuation, then falls below never-users.
Metastasis-directed radiotherapy without systemic therapy yields promising outcomes in oligometastatic ccRCC
MRWS was shown to prolong the time off systemic therapy and was associated with favorable tolerability.
Aquablation procedures for prostate cancer completed at ambulatory surgery center
The WATER IV PCa trial is comparing first-line Aquablation therapy with radical prostatectomy for the treatment of patients with localized prostate cancer.
FDA grants priority review to expanded indication of flibanserin in HSDD
The expanded labeling would enable the use of flibanserin to treat hypoactive sexual desire disorder in postmenopausal women.
FDA clears image-guided navigation platform for focal therapy in prostate cancer
The new advanced annotation workflow on the UroNav System is designed to work in tandem with DynaCAD Urology to support focal therapy planning.
Category III CPT code issued for Enhanced Lithotripsy System
The code, 0991T, will become effective on January 1, 2026.
When to report 50320 with 49187 for nephrectomy procedures
"As always, we encourage you to communicate among all team members and pay attention to your documentation," write Jonathan Rubenstein, MD, and Mark Painter.
Daniel D. Joyce, MD, MS, discusses the economics of trimodal therapy in MIBC
Ultimately, the take-home message for practicing urologists is to apply TMT judiciously, taking into account the patient's clinical profile, personal values, and financial situation.
Irreversible electroporation with NanoKnife found safe, effective for prostate tissue ablation
The PRESERVE trial met its primary end point by demonstrating a negative in-field biopsy rate of 71% at 12 months.
Water vapor therapy demonstrates superior outcomes vs pharmaceutical therapy for BPH
According to the authors, these data support Rezūm as an alternative first-line treatment option for patients at risk of BPH progression.
Darolutamide plus ADT approved in EU for mHSPC
This approval enables the use of darolutamide plus ADT with or without chemotherapy.
Mitomycin intravesical solution demonstrates long-term durability in LG-IR-NMIBC
Mitomycin intravesical solution was granted FDA approval in June 2025 for recurrent LG-IR-NMIBC.
Experts urge FDA to remove black box warning on low-dose vaginal estrogen
In a panel meeting convened by the FDA, experts urged the agency to revise or remove the outdated boxed warning on hormone therapies for menopause.
Phase 3 TALAPRO-2 data of talazoparib plus enzalutamide published in The Lancet
In both cohorts, the combination of talazoparib plus enzalutamide led to a significant improvement in overall survival vs enzalutamide alone.
Urology in focus: Key moments from 2025
Take a look back through some of the top stories from the first half of the year.
Enrollment goal met in trial of 64Cu-SAR-bisPSMA vs. 68Ga-PSMA-11 PET/CT
The phase 2 Co-PSMA trial enrolled 50 patients with biochemical recurrence of prostate cancer.
FDA, French ANSM greenlight pivotal trial of UroActive smart implant for male SUI
The SOPHIA2 trial will assess the safety and efficacy of the UroActive implant in men with SUI.
FDA grants priority review to NDA for TAR-200 in BCG-unresponsive NMIBC
The new drug application for TAR-200 is supported by data from cohort 2 of the phase 2b SunRISe-1 trial.
Phase 1/2 trial of INKmune therapy for mCRPC meets primary end point
How to bill for mitomycin for intravesical solution in NMIBC
Biopsy grade alone may underestimate risk in GG1 prostate cancer
FDA updates in urology: July 2025