Greenwood

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.

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.

Researchers are evaluating the use of a treatment called Ruvidarae TLD-1433 combined with photodynamic therapy PDT in patients who have Non-Muscle Invasive Bladder Cancer NMIBC with Carcinoma In-Situ CIS that is unresponsive or intolerant to Bacillus Calmette-Guerin BCG therapy. This phase II, open-label, single-arm study is conducted across multiple centers in Canada and the United States and includes patients with specific BCG treatment histories or intolerance. The study aims to assess the treatments ability to achieve a complete response in this patient population. Participants will receive one intravesical instillation of Ruvidarae TLD-1433 into the bladder, followed by photodynamic therapy using a specialized laser system called TLC-3200. The treatment involves a 60-minute infusion of Ruvidarae, rinsing, and light activation to the bladder wall. Based on patient response, up to two additional re-induction procedures may be administered. The study includes a screening period of up to 60 days to confirm eligibility. After treatment, patients will be followed for up to 15 months with regular assessments at specific intervals to monitor safety and efficacy, including cystoscopy and urine cytology. For those who achieve a complete or indeterminate response, survival and safety will be monitored for up to 36 months. The main outcome measured is the complete response rate, with additional evaluation of response duration and long-term observations. The study includes strict monitoring and data collection to assess treatment effects over time.

Researchers are evaluating the safety and effectiveness of intravesical administration of detalimogene EG-70, a novel non-viral gene therapy, in patients with non-muscle invasive bladder cancer NMIBC. The study focuses on patients with carcinoma in situ CIS unresponsive to BCG therapy and other high-risk NMIBC patients, including those who are BCG-nafve or incompletely treated. The trial includes a Phase 1 dose-escalation to determine safety and recommended dose, followed by a Phase 2 to assess treatment effectiveness. Participants will receive EG-70 via bladder instillation with a catheter in cycles lasting about 12 weeks. Phase 1 involves up to four cycles with either two or four doses per cycle, aiming for a 60-minute retention time. Phase 2 participants receive four instillations per cycle for up to four cycles at the recommended dose. Those achieving complete response may continue with maintenance treatment involving two doses per 12-week cycle. A substudy includes a surfactant bladder rinse before EG-70 instillation, with a shortened administration time. During the study, participants undergo regular assessments including cystoscopy, urine cytology, and biopsies to monitor response and safety. Researchers track adverse events, treatment response rates, duration of response, progression-free survival, and quality of life over periods ranging from weeks to years. Safety monitoring follows standardized criteria, and participants may continue in maintenance cycles if responding. The total study duration extends up to approximately nine years from start to completion.

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 conducting a global, prospective, multi-center observational study to gather real-world data on the long-term effectiveness, economic value, and technical performance of Boston Scientifics commercially approved neurostimulation systems for pain management. The study focuses on patients using these neurostimulation devices according to their approved instructions for use in routine clinical practice. Participants will first undergo a neurostimulation trial period using any commercially approved Boston Scientific neurostimulator for pain. Those who experience a positive outcome from this trial may then receive a permanent implant of the neurostimulation system. Treatment customization will be guided by the investigators judgment and routine care practices at each site. During the study, participants will be observed to collect information on clinical outcomes, technical device performance, and economic factors related to neurostimulation therapy. The research team will monitor participants over the long term to assess how well the therapy manages pain and its associated benefits. The study is expected to continue until May 2035, with ongoing follow-up and data collection throughout this period.