"In the cisplatin-ineligible cohorts, we showed that high event-free survival and overall survival rates can be achieved at 12 and 36 months in patients treated with neoadjuvant avelumab in combination with cisplatin-based chemotherapy," says Jeremy Blanc, MD.
Gilead reported that a numerical improvement in OS favoring sacituzumab govitecan was observed, though the end point was not reached in the intent-to-treat population.
Patients with high-risk disease were shown to have a significantly higher mean value of SUVmax compared with patients with low-risk disease (23.5 ± 13.2 vs 10.6 ± 5.4; P < 0.05).
The IND acceptance will initiate the launch of a phase 1 trial to evaluate the safety, tolerability, and preliminary anti-tumor activity of 225Ac-FL-020 in patients with mCRPC.
"This announcement is an important step in increasing the awareness and accessibility of OnQ Prostate beyond its earliest adopters, so that more physicians and patients can benefit from this technology," says Brittany Hunt.
The approval is based on findings from the phase 3 CheckMate-901 study.
Regarding patient-reported outcomes, those who underwent URS showed higher urinary symptoms, greater pain intensity, and greater pain interference at 1 week following surgery compared with those who underwent SWL.
“If approved by the FDA, this new product will have a significant impact on prostate cancer patients, physicians, and their caregivers by helping to eliminate the inequity of access to PSMA-PET agents, and increase the ability to accurately diagnose cancer early, reducing the cost of care, and increasing the probability of patients’ survival," says Mike Crosby.
The predictive models identified the number of previous UTI episodes, prior β-lactam nonsusceptibility, prior fluoroquinolone treatment, Census Bureau region (particularly in the South), and race as key predictors of having a non-susceptible isolate to 3 or more antibiotic classes.
Among the 3 CD70-positive patients, the ORR was 66.7%, with 2 patients achieving a partial response.
"Since the phase 2 data of the combination therapy of LAE002 (afuresertib) plus LAE001 demonstrated encouraging anti-tumor activity and safety profile in patients with mCRPC, a following phase 3 pivotal trial design has been discussed with the US FDA and the approval for the protocol has been received this month," said Yong Yue, MD, PhD.
The first-in-human study expects to begin dosing patients with DF9001 in combination with pembrolizumab in Q4 of 2024.
"When thinking about living with prostate cancer, this is really a couples' disease, and partners' unmet needs should be part of the conversation," says Stacy Loeb, MD.
Preliminary results from the CUPID study were based on data from 11 evaluable patients with advanced prostate cancer.
RAG-01 is an saRNA therapy that is delivered via intravesical instillation and is designed to target and activate p21, a tumor suppressor gene.
"We were deeply impressed by Galen's performance in the study, that based on our validation, clearly showed how Ibex can support our clinicians in improving diagnostic quality and efficiency, and as a result we have decided to implement it routinely,” says Junya Fukuoka, MD, PhD.
Yōni.Fit is a soft vaginal insert intended to reduce urine leakage due to SUI without interfering with voluntary urination.
"Prolaris precisely describes the difference in metastasis outcomes for men receiving monotherapy (RT) vs multimodal therapy (RT+ADT), and further tells me precisely what the risk of death is for a man on surveillance," says Jonathan D. Tward, MD, PhD.
"225Ac-PSMA-Trillium is a novel approach, which could provide a new treatment to address this unmet need in mCRPC,” says Fred Saad, MD, FRCS.
The dose escalation/dose expansion study is evaluating the safety and efficacy of AB-2100 in patients with ccRCC who either came back or did not improve following prior treatment with a checkpoint inhibitor and a VEGF inhibitor.
“The association of lower testosterone concentrations with higher all-cause mortality was present irrespective of luteinizing hormone concentrations, indicating that low testosterone was the main factor," says Bu B. Yeap, MBBS, FRACP, PhD.
The Contouring Assistant now marks Profound Medical’s second FDA-cleared TULSA-AI module.
Patients who scored in the highest quintile of plant-based diet index scores had a 47% lower risk of prostate cancer progression compared with those in the lowest quintile.
"Until now, no single center has had enough samples of the quality needed for comprehensive multi-omics profiling, as we’ve carried out in this study,” says Saravana Mohan M. Dhanasekaran, PhD.
The Prescription Drug User Fee Act target action date is set for quarter 3 of this year.
The phase 2/3 AlphaBreak trial is evaluating the safety and efficacy of FPI-2265 in patients with mCRPC who have been previously treated with 177Lu-PSMA radiotherapy.
Updated data from the phase 2 TAMARCK study continued to show safety and preliminary efficacy with the B7-H3–targeting antibody-drug conjugate vobramitamab duocarmazine in patients with metastatic castration-resistant prostate cancer.
“The results of the BRAVO study performed within the VA health care system showed significant decreases in the risk of recurrence and progression, as well as the potential for improved overall survival in patients who received a BLC compared to patients who received WLC only,” says Stephen B. Williams, MD, MBA, MS, FACS, FACHE.
Patients who received PUL experienced a greater reduction in inference regarding outdoor entertainment and community activities at 1 month vs WVTT.
"Our research shows that the identification of these genetic factors, even in geriatric patients, is important for determining targeted treatment and overall patient survival,” says Mahdi Taha, DO, FACOI, FACP.
