Pella

Researchers are investigating whether adding the chemotherapy drug Docetaxel to the usual hormone treatments can better control metastatic castration sensitive prostate cancer (mCSPC) in patients who have a less than optimal PSA response after 6 to 12 months of androgen-targeting therapy. This phase III, open-label, randomized international trial compares the effectiveness of Docetaxel combined with standard Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitors (ARPI) versus ADT and ARPI alone. The study focuses on men with metastatic prostate adenocarcinoma who have a suboptimal PSA decline following initial hormone therapy. Participants receive standard ADT and an ARPI such as abiraterone, enzalutamide, apalutamide, or darolutamide, which are assigned before enrollment. At enrollment, patients are randomized to receive either the addition of Docetaxel chemotherapy or no chemotherapy alongside their hormone therapy. The goal is to assess whether this combination reduces cancer growth or spread compared to hormone therapy alone. Treatment begins within five working days after enrollment, with close monitoring throughout the study. Throughout the trial, participants undergo regular assessments including PSA measurements to monitor cancer activity and overall survival tracked at 39 months. Eligibility requires stable organ function, performance status, and recovery from prior treatment side effects. Patients are monitored for adverse events, safety, and treatment response. The study also ensures participants and their partners use contraception if of childbearing potential, and participants must be accessible for treatment and follow-up visits to document outcomes and safety data.

Researchers are evaluating two digital mindfulness meditation programs to support mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III trial focuses on women diagnosed with breast cancer at age 50 or younger who have completed their main cancer treatments at least six months ago. The study aims to compare a live, instructor-led online program to a self-paced app-based program and also to explore factors that might influence how well these interventions work, including psychological distress levels and social factors like race and education. Participants will be assigned to one of three groups: a live online Mindful Awareness Practices (MAPs) program delivered over Zoom, a self-paced MAPs digital app, or a meditation-only control group. The live online program includes guided meditations, exercises to manage pain and emotions, and cultivating kindness, with daily home practice increasing from 5 to 20 minutes. The app program unlocks lessons sequentially as participants progress. Meditation use will be tracked across all groups to measure engagement. During the study, participants will report depressive symptoms two weeks after completing the intervention. Researchers will also collect information on emotion regulation strategies and social determinants of health, and monitor how much participants practice mindfulness to understand the programs' effects. The total intervention lasts six weeks, and participants must be able to use a digital device and communicate in English or Spanish. Safety and participation are closely monitored throughout the study.

Researchers are evaluating an online educational program called Current Together After Cancer (CTAC) designed to help patients who have had surgery for stage II or III colorectal cancer receive follow-up care that follows current medical guidelines. This phase III trial aims to see if CTAC improves patients' knowledge about surveillance, their confidence in managing their care, and satisfaction with support received from a chosen adult supporter. Proper surveillance after colorectal cancer surgery is important to detect any return of the disease early, but many survivors do not receive recommended follow-up care, possibly due to lack of information or support. Participants are randomly assigned to one of two groups. One group receives access to the CTAC intervention website, which includes educational content and interactive modules to help manage post-surgery surveillance. The other group accesses a control website with general health education. Both patients and their chosen supporters can use their assigned website as often as they like for up to 16 months. Supporters are adult individuals identified by the patient who help with their cancer journey. During the study, researchers will measure how many patients receive surveillance care that follows guidelines at 12 and 16 months. They will also assess patients' knowledge about surveillance, confidence in managing their care, and satisfaction with supporter involvement at 3 and 16 months. Surveys and interviews will be conducted to gather this information. The study will also explore how well the intervention fits into clinical practice and how supporter participation affects outcomes.

Researchers are evaluating two chemotherapy treatments, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for advanced, unresectable, or metastatic HER2 negative adenocarcinoma of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine whether adding irinotecan to the usual FOLFOX regimen improves overall survival and other outcomes such as progression-free survival, response rates, and treatment tolerability. The study also explores biomarkers like PD-L1 combined positive score and cell free DNA to understand treatment effects better. Participants are randomly assigned to one of two treatment groups. One group receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with nivolumab as needed, while the other group receives fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with nivolumab as needed. All drugs are given intravenously. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional testing. During the study, participants are closely monitored for overall survival for up to two years after randomization. Researchers assess safety, side effects, and patient-reported outcomes to evaluate treatment tolerability. The trial also tracks progression of disease and response to therapy using imaging and other clinical evaluations. Participation includes regular imaging, blood collection, and completing questionnaires to help understand the impact of these treatments.

Researchers are evaluating a Master Screening and Reassessment Protocol (MSRP) called myeloMATCH for people with myeloid cancers such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This Phase 2 study aims to improve how patients are matched to clinical trials or standard treatments by testing bone marrow and blood samples for specific biomarkers. These markers help doctors understand the cancer's characteristics and identify targeted treatments or assign patients to a standard of care treatment pathway called the Tier Advancement Pathway (TAP). Participants undergo bone marrow aspiration and blood collection for rapid genetic testing to identify mutations that guide treatment assignment. Based on these results, patients are placed into treatment substudies targeting their cancer type or, if no targetable mutation is found, into TAP to receive standard care with ongoing monitoring. The study includes multiple treatment arms with various drug regimens such as azacitidine, venetoclax, daunorubicin, cytarabine, and others, delivered through intravenous, subcutaneous, or oral routes. Some participants may receive hematopoietic stem cell transplants and conditioning therapies. Treatment cycles generally repeat every 21 to 28 days, with adjustments based on response and tolerance. Throughout the trial, participants undergo regular assessments including bone marrow biopsies, blood tests, imaging scans (such as chest x-rays, CT, PET, echocardiography, and MUGA scans), and specimen collection for translational medicine and biobanking. The study monitors treatment assignment timing, response rates, remission status, measurable residual disease, survival outcomes, and safety. Participants remain on study for ongoing reassessment and potential assignment to higher-tier treatments or TAP. The protocol requires informed consent and continues as long as disease progression or unacceptable toxicity does not occur.

Researchers are evaluating whether 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy is as effective as 12 months of the same treatment for patients with early-stage HER2-positive breast cancer who have no remaining invasive cancer after preoperative chemotherapy with trastuzumab. This phase III trial focuses on patients who achieved a pathologic complete response (pCR), aiming to assess recurrence-free survival and quality of life outcomes. The study also explores differences in side effects and survival among subgroups based on treatment delivery and hormone receptor status. Participants are randomly assigned to receive either 6 or 12 months of HER2-targeted therapy, including trastuzumab and possibly pertuzumab, administered intravenously or subcutaneously every 21 days. The treatment cycles continue up to 9 or 17 cycles respectively, unless disease progression or unacceptable side effects occur. Throughout the trial, patients undergo regular heart function tests (echocardiography or MUGA), breast imaging (mammography, ultrasound, or MRI), and may optionally provide blood and tissue samples. During the study, patients complete quality of life questionnaires and are monitored for cancer recurrence and side effects. Follow-up visits occur every 6 months for 5 years and then annually up to 10 years after registration. The main outcomes measured include time without cancer recurrence and patient-reported quality of life at 12 months. Safety and long-term effects of the different treatment durations are also assessed.

Researchers are evaluating an enhanced digital delivery model using a chatbot to increase the uptake of genetic counseling and testing among adolescents and young adult (AYA) cancer patients. Genetic testing for cancer predisposition syndromes is an important practice that can guide improved screening and risk reduction, but many AYAs do not receive recommended genetic services. This trial compares the chatbot-enabled approach to standard remote genetic services to see if it improves access and outcomes while potentially reducing provider time. Participants are randomized into two groups: one receives standard telehealth visits with a genetic counselor for pretest education and result disclosure, along with standard genetic testing. The other group gets access to the Genetic Journey Chatbot for digital pretest education and can request telehealth counseling as needed, followed by standard genetic testing and telehealth disclosure. The chatbot also provides ongoing support, answers questions, assesses barriers, and sends reminders during the testing period. A third group of non-patient participants completes interviews about the study. During the study, patients complete assessments at baseline and are followed up at 6 and 12 months. Researchers measure uptake of genetic counseling and testing within six months, as well as cognitive, emotional, behavioral outcomes, and costs over time. The study includes surveys, interviews, and ongoing monitoring of patient experiences and outcomes to evaluate the effectiveness and acceptability of the digital chatbot approach compared to standard services.

Researchers are evaluating treatments for patients with higher-risk myelodysplastic syndrome (MDS) that have mutations in the IDH2 gene. This phase II trial compares the usual treatment of cedazuridine-decitabine (ASTX727) alone to a combination of ASTX727 with enasidenib. ASTX727 combines two drugs to help the bone marrow make normal blood cells and kill abnormal cells, while enasidenib may stop the growth of cancer cells by blocking certain enzymes. The study aims to compare the complete remission rates and other important outcomes between these two treatment approaches. Participants are randomly assigned to one of two treatment groups. The first group receives ASTX727 orally once daily on days 1 to 5 of each 28-day cycle. If they do not achieve a complete response after 6 cycles, they may switch to the second group. The second group receives ASTX727 on the same schedule plus enasidenib daily for 28 days each cycle. Patients in both groups have bone marrow biopsies and aspirations during the study, with optional additional samples collected. Treatment continues as long as there is no disease progression or unacceptable side effects. Throughout the study, participants undergo various tests including blood and bone marrow samples, and may provide buccal swabs. Researchers assess response rates, survival times, side effects, and genetic changes related to the disease and treatment. After finishing treatment, patients are followed every 6 months for up to 5 years to monitor long-term outcomes and safety. The main outcome measured is the complete response rate up to 4 cycles of treatment.

Researchers are evaluating the effect of triptorelin compared to no triptorelin in preventing ovarian damage in adolescent and young adult (AYA) females under 40 years old with cancer who are receiving chemotherapy containing alkylating agents. These agents, while common in cancer treatment, may harm the ovaries and affect future fertility. Triptorelin works by blocking certain hormones to temporarily slow or pause ovarian activity, potentially reducing damage during chemotherapy. This is a phase III randomized clinical trial excluding breast cancer patients but including other tumor types originating in the breast. Participants are randomly assigned to one of two groups. One group receives triptorelin injections up to 14 days before starting standard chemotherapy, with a possible second dose given 24 weeks later if chemotherapy continues beyond that time. The other group receives only the standard chemotherapy without triptorelin. Throughout the study, participants undergo blood sample collection. After treatment completion, follow-up visits occur at 1 and 2 years to monitor ovarian function and other outcomes. During the study, researchers collect blood samples to measure ovarian reserve using anti-Mullerian hormone (AMH) levels at 2 years post-chemotherapy. They also track the number of newly diagnosed AYA female cancer patients enrolled and monitor how well the study is enrolling participants. Additional assessments include symptoms related to estrogen loss, menstrual patterns, quality of life, and long-term reproductive health. The total follow-up period extends up to 2 years after chemotherapy completion to evaluate ovarian function and safety.