Jesus Del Monte

Researchers are evaluating the efficacy and safety of lutetium 177Lu vipivotide tetraxetan AAA617 in adult men with oligometastatic prostate cancer OMPC that is progressing after initial treatment to the primary tumor. The goal is to control tumor recurrence and delay progression to fatal metastatic disease while preserving quality of life by postponing androgen deprivation therapy ADT. This is a Phase III, open-label study sponsored by Novartis Pharmaceuticals. Participants will receive stereotactic body radiation therapy SBRT to all metastatic prostate cancer lesions before starting treatment. Those in the investigational group will then receive up to four cycles of AAA617 every six weeks, with each cycle consisting of a dose of 7.4 GBq 200 mCi administered once. The control group will receive SBRT followed by observation without additional treatment. SBRT procedures last about three weeks, and treatment or observation continues until disease progression. Participants will undergo baseline assessments including PETCT scans with gallium 68Ga gozetotide or piflufolastat 18F, CT or MRI and bone scans. Follow-up visits occur weekly during weeks 1 and 3 of each treatment cycle and every 16 weeks thereafter until disease progression. Researchers will monitor metastasis-free survival, time to hormonal therapy, PSA progression, quality of life, pain, adverse events, and overall survival over approximately 6.5 years of study duration.

Researchers are investigating the effects of vericiguat compared to a placebo in children with heart failure caused by left ventricular systolic dysfunction. This study aims to see if vericiguat is better than a placebo at lowering levels of a heart failure marker called NT-proBNP over 16 weeks. The trial includes a base period and an optional extension period to further evaluate safety and long-term effects. During the base period, participants receive vericiguat orally once daily either as tablets in doses of 2.5 mg, 5 mg, or 10 mg, or as a suspension of 0.2 mgmL or 1 mgmL for up to 52 weeks. Another group receives a placebo in matching forms and schedules. After completing the base period, eligible participants may join the extension period, where they continue to receive vericiguat under similar dosing for additional monitoring. Participants will undergo regular assessments, including measuring NT-proBNP levels at baseline, Week 16, and Week 52 during the base period, as well as monitoring heart events and adverse effects. In the extension period, safety is tracked for up to 8 years, including adverse events and reasons for stopping the study drug. Pharmacokinetics of vericiguat are also studied through blood sampling at scheduled weeks. The total participation time may extend over several years for those in the extension phase.