Jeffersonville

Researchers are studying PRL-02 depot, a potential injectable treatment for men with advanced prostate cancer, including those whose cancer has returned or not responded to previous treatments. The trial aims to evaluate the safety and tolerability of PRL-02 depot alone or combined with enzalutamide, as well as to determine the appropriate dose. This Phase 1 study is sponsored by Astellas Pharma Global Development, Inc. and focuses on men with metastatic or biochemical relapse forms of prostate cancer. Participants will be divided into groups receiving different doses of PRL-02 depot injected into a muscle every 12 weeks. They will also take daily oral doses of either dexamethasone, prednisone, or enzalutamide depending on their study group and prior treatments. The study has two parts dose escalation with small groups receiving increasing doses, and dose expansion involving men previously treated with specific hormone therapies. During the trial, men will visit the clinic multiple times for health checks, scans, and blood tests to monitor side effects, disease progression, and testosterone suppression. After the final visit, those whose cancer has not worsened will continue to have periodic health assessments and scans. The main outcomes include tracking dose limiting toxicities and adverse events over up to four years, along with detailed pharmacokinetic and response measurements.

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Researchers are evaluating the effectiveness of TAR-210 compared to investigators choice of intravesical chemotherapy in people with intermediate-risk non-muscle invasive bladder cancer IR-NMIBC who have specific FGFR mutations or fusions. This Phase 3 randomized study aims to compare disease-free survival between these treatment options, with the goal of understanding which may better prevent recurrence or progression of the cancer. Participants are randomly assigned to one of two groups. Group A receives TAR-210, which is inserted into the bladder on Day 1 and removed after 12 weeks, with one insertion every 12 weeks over about one year. Group B receives intravesical chemotherapy using mitomycin C or gemcitabine, chosen by the investigator, given once weekly for 4 to 6 doses followed by maintenance treatment for at least six months up to one year. The study includes a substudy with similar treatment groups. During the trial, participants will undergo multiple cystoscopies and urinary tumor resections as needed to monitor for disease recurrence or progression. Researchers will measure disease-free survival from the time of randomization until recurrence, progression, or death over approximately four years. Additional assessments include quality of life questionnaires, adverse events monitoring, and survival outcomes. Participants are followed closely with various evaluations throughout the study duration.

The trial investigates the efficacy and safety of TYRA-300 in adults with FGFR3 altered low-grade, intermediate-risk non-muscle invasive bladder cancer NMIBC. This Phase 2, multicenter, open-label study focuses on participants with specific tumor characteristics confirmed by diagnostic biopsy and who meet intermediate risk criteria according to updated guidelines. The study is designed to evaluate a new oral treatment option for this condition, providing important insights into its potential role in managing this cancer type. Participants receive TYRA-300 as a self-administered oral tablet daily in one of several dose groups 60 mg, 50 mg, or a dose to be determined. The study is randomized and open-label, with participants assigned to different dose cohorts to assess treatment effects. The treatment period and dose details are structured to monitor safety and response over time, allowing evaluation of how well the drug works in this patient group. Throughout the study, participants are monitored for efficacy and safety outcomes, including disease response at 3 months, duration and timing of any recurrence, recurrence-free survival at 12 and 24 months, and progression-free survival. Safety is assessed through adverse event monitoring up to 2 years. Participants undergo various clinical evaluations, including tumor assessments and laboratory tests, to track treatment effects and health status. The total study duration extends to September 2028, with ongoing follow-up to capture long-term outcomes and tolerability.

This trial focuses on men with metastatic castrate-resistant prostate cancer mCRPC who have previously been treated with PROVENGE4 immunotherapy. The study aims to investigate changes in immune responses following a booster dose of sipuleucel-T, an immunotherapy treatment. The trial is a phase 2, multicenter, open-label study designed to better understand immune boost responses in this patient group. Participants who have completed their initial treatment with PROVENGE4 will be randomly assigned to one of two groups one group will receive a single booster infusion of sipuleucel-T approximately 6 to 9 months after their initial treatment, while the other group will not receive any additional intervention. The sipuleucel-T is delivered as an intravenous infusion. Both groups will be monitored according to the study schedule. Throughout the study, participants will undergo evaluations to measure immune responses to specific prostate cancer antigens after the booster infusion. Researchers will also monitor adverse events and overall survival over a 5-year period. The study involves regular follow-up visits to assess safety and immune activity, with total participation lasting up to five years after treatment.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating the safety and efficacy of cretostimogene grenadenorepvec in participants with high-risk non-muscle-invasive bladder cancer NMIBC. This Phase 2, multi-arm, multi-cohort, open-label study includes participants who are either naive to Bacillus Calmette-Guerin BCG treatment, previously exposed to BCG, or unresponsive to BCG treatment. The study aims to compare different dosing methods and combinations with gemcitabine to better understand treatment effects in various NMIBC patient groups. The study is organized into several cohorts and arms based on the participants prior BCG treatment status and pathology. Cretostimogene grenadenorepvec is administered intravesically directly into the bladder using either the current or an alternative instillation method. In some arms, gemcitabine is also given either concurrently or sequentially with the study drug. Treatment involves weekly induction courses for six weeks, followed by reinduction if needed, and maintenance therapy over up to three years with treatments spaced every three to six months. Participants will undergo regular assessments including urine cytology, cystoscopy, upper tract evaluation, and biopsies or resections if indicated, every three months for the first two years and then every six months for up to four years or until disease recurrence. The study measures include complete response rates and high-grade event-free survival at various time points. Safety and duration of response are also monitored to evaluate the study treatments over the long term.

Researchers are evaluating the effectiveness and safety of Dabogratinib TYRA-300 in people with low grade upper tract urothelial carcinoma, a type of cancer affecting the urinary tract. This Phase 2AB open-label study focuses on patients with FGFR3-positive tumors and aims to understand how well the drug works in reducing tumor presence within six months. Participants will receive daily oral doses of Dabogratinib at different strengths60mg, 80mg, or a dose to be determined. The study is randomized and involves multiple centers, with participants assigned to one of three dose groups to assess the drugs impact and safety. During the trial, participants will be monitored for response to treatment, including complete tumor response within six months and duration of response up to 36 months. Safety and kidney function will be observed for up to two years, alongside other measures like tumor resectability and renal preservation. The total participation duration spans until the studys completion in November 2030.

Researchers are evaluating ORIC-944, a selective small molecule inhibitor targeting PRC2, in patients with metastatic prostate cancer. This open-label, phase 11b study aims to establish the safety and preliminary antitumor activity of ORIC-944 both alone and combined with androgen receptor pathway inhibitors ARPIs. The study involves patients who have progressed after prior ARPI therapies and explores dose escalation and optimization across different patient groups. Participants receive ORIC-944 orally once daily in 28-day continuous cycles either alone or combined with ARPIs such as abiraterone, apalutamide, darolutamide, or enzalutamide. The study has three parts Part I tests ORIC-944 alone Part II tests combinations with ARPIs Part III optimizes dosing of ORIC-944 with ARPIs in separate cohorts. Future combinations with abiraterone or enzalutamide may also be explored. During the study, participants undergo assessments including skin and tumor biopsies and monitoring of organ function and performance status. Researchers measure drug concentrations in the blood, antitumor responses, progression-free survival, and PSA levels. Safety and activity are evaluated over months, with follow-up for up to 36 months. The trial is sponsored by ORIC Pharmaceuticals and runs from 2022 to 2028.

This research aims to understand how two common medicines, buprenorphine and morphine, affect recovery in newborns born at or after 36 weeks gestation who have Neonatal Opioid Withdrawal Syndrome NOWS. NOWS occurs in infants exposed to opioids before birth and can cause symptoms like irritability and feeding difficulties. The study compares whether one medicine helps babies become medically ready for discharge faster and leads to better overall outcomes. The study reviews medical records from about 796 infants treated with either buprenorphine or morphine at around 22 hospitals in the United States. Since treatment choices are made by clinical teams during routine care, researchers use advanced methods to fairly compare outcomes between the two medicines. No new treatments, procedures, or visits are involved, and no families are contacted during this observational study. Participants existing clinical data, including birth details, withdrawal symptoms, treatment information, feeding, and clinical outcomes, will be collected securely. The main outcome measured is the time from birth until the infant is medically ready for discharge. Other outcomes include length of hospital stay and safety events. All data are handled confidentially under privacy rules, and the studys findings may help improve future care for infants with NOWS.