Drexel Hill

Researchers are evaluating the combination of ribociclib and standard adjuvant endocrine therapy (ET) in adults with hormone receptor-positive, HER2-negative early breast cancer, specifically those in Anatomic Stage Group III, IIB, and some of Stage IIA. This phase IIIb, open-label, multicenter study aims to understand how this combination affects invasive breast cancer-free survival (iBCFS) in a patient population close to routine clinical practice. Participants will receive ribociclib 400 mg orally once daily on days 1 to 21 of each 28-day cycle, combined with daily ET for 36 months (about 39 cycles). ET options differ for postmenopausal women (letrozole, anastrozole, or exemestane) and for pre/perimenopausal women and men, who receive ET plus either goserelin or leuprolide injections given every 1 to 3 months. The treatment period begins with the first ribociclib dose and includes safety follow-up 30 days after the last dose. After treatment, participants will be followed up until death, withdrawal, loss to follow-up, or up to 48 months after the last participant’s first dose. During the study, participants will be regularly evaluated for breast cancer recurrence, side effects, and quality of life using various assessments such as survival rates, adverse event monitoring, and standardized questionnaires on fatigue, endocrine symptoms, and overall well-being. Safety follow-up calls will be conducted 30 days after treatment ends. This comprehensive monitoring extends up to approximately six years, ensuring detailed data collection on treatment impact and participant health throughout and after the study period.

Researchers are evaluating whether adding the drug apalutamide to the usual hormone therapy and radiation therapy after surgery improves outcomes for men with prostate cancer that has spread to lymph nodes. This phase III trial focuses on patients who have undergone radical prostatectomy and have detectable prostate-specific antigen (PSA), aiming to see if apalutamide can help prevent the cancer from spreading further and extend the time without metastasis. Participants are randomly assigned to one of two groups. One group receives standard hormone therapy and radiation to the pelvis and prostate bed for 5 to 8 weeks. The other group receives the same treatment plus daily oral apalutamide for 90 days per cycle, repeated for up to eight cycles, unless disease progression or unacceptable side effects occur. Both groups may undergo imaging tests like CT, MRI, bone scans, and PET scans as needed, along with blood sample collections. Throughout the study, participants are closely monitored with scans and blood tests to assess cancer progression and treatment effects. Researchers will measure metastasis-free survival as the primary outcome, along with quality of life, overall survival, biochemical progression, time to local progression, castrate resistance, cancer-specific survival, and adverse events. After treatment, participants will have follow-up visits every six months for three years, then yearly thereafter to track long-term outcomes.

Researchers are investigating treatments for men with prostate cancer that has returned after surgery, specifically those with biochemical recurrence indicated by rising prostate specific antigen (PSA) levels. This phase III trial examines whether adding enhanced therapy, which includes apalutamide combined with abiraterone and prednisone, to standard care (prostate radiation therapy and short-term androgen deprivation) improves outcomes compared to standard care alone. The study also explores if adding targeted radiation to metastatic sites identified by PET imaging benefits patients whose cancer has spread beyond the pelvis. Participants undergo a baseline PET scan using CT or MR imaging to detect cancer spread. Based on these results, they are randomized into one of four treatment groups: standard radiation plus androgen deprivation; standard radiation, androgen deprivation, and apalutamide; similar treatments for those with metastases; and a group receiving additional targeted radiation to metastatic sites. Treatments last approximately six months, with radiation delivered through various advanced techniques, and hormonal therapies given via injections or orally. Some patients may have repeat PET scans during the study to monitor disease progression. During the trial, participants will have regular follow-up visits every three months for two years, then less frequently up to ten years. Researchers will assess progression-free survival, overall survival, PSA levels, quality of life, cognitive function, and adverse events. Quality of life and fatigue questionnaires are administered at several time points. Safety and treatment responses will be closely monitored using imaging and lab tests throughout the study duration.