Greenwood

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are evaluating a new treatment for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma In-Situ (CIS) who are 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. It targets patients who have had a relapse or intolerance after specific courses of BCG treatment and aims to assess the safety and effectiveness of a new combination treatment involving a drug and light therapy. The study involves up to 90 patients receiving treatment with Ruvidar4 (TLD-1433), which is infused directly into the bladder. This is followed by photodynamic therapy (PDT) using a special green laser light device called the TLC-3200 system. Patients receive one treatment procedure initially, with up to two additional re-induction treatments depending on their response. The treatment includes careful bladder preparation, drug instillation, and controlled light exposure to activate the medication inside the bladder. Participants will be closely monitored through a screening period lasting up to 60 days before treatment, followed by a 15-month follow-up phase. Assessments occur at multiple time points after treatment, including cystoscopy, urine tests, and other safety and efficacy evaluations. For those who respond well or have uncertain results, long-term monitoring for up to 1080 days will track cancer control, safety, and any surgery requirements. The main outcome is the complete response rate to treatment over this period.

Researchers are evaluating the safety and effectiveness of EG-70, a new gene therapy designed to trigger a local immune response in the bladder, for patients with non-muscle invasive bladder cancer (NMIBC) who have carcinoma in situ (CIS). This trial includes patients who did not respond to BCG therapy as well as those who are BCG-nafve or received incomplete BCG treatment. The study consists of two phases: Phase 1 focuses on safely determining the recommended dose, and Phase 2 assesses how well the treatment works. In Phase 1, patients receive up to four cycles of EG-70 administered directly into the bladder via catheter, with each cycle lasting about 12 weeks and involving either 2 or 4 doses per cycle. In Phase 2, patients receive up to four 12-week treatment cycles at the recommended dose, followed by maintenance treatment cycles if they achieve a complete response. Maintenance cycles involve two doses per 12-week period, and patients may receive up to eight maintenance cycles total. The therapy is delivered as a 50 mL bladder instillation with a targeted retention time of 60 minutes. Participants will have regular assessments including exams, urine cytology, and biopsies to monitor tumor response and safety. Researchers will track adverse events over approximately 2 to 3 years and measure the percentage of patients achieving a complete response at 48 weeks. Safety evaluations will follow standard criteria, and follow-up will continue for those with ongoing treatment benefits. Total participation may last several years, depending on individual response and treatment cycles.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and effectiveness of cretostimogene grenadenorepvec in adults with high-risk non-muscle-invasive bladder cancer (NMIBC) in this Phase 2, open-label study. The study includes multiple groups based on prior Bacillus Calmette-Guerin (BCG) treatment status: BCG-nave, BCG-exposed, and BCG-unresponsive or exposed. It aims to assess disease control and response in these different patient groups using cretostimogene alone or combined with gemcitabine. Participants are assigned to various cohorts and arms depending on their NMIBC subtype and treatment history. Treatment involves weekly instillations of cretostimogene for six weeks, with a possible reinduction course at 3 months if high-grade disease remains. Maintenance therapy follows with three weekly treatments every three months in the first year and every six months during the second and optional third years. Cohort CX participants receive cretostimogene plus gemcitabine either concurrently or sequentially. Throughout the study, participants undergo regular evaluations including urine cytology, cystoscopy, upper urinary tract assessment, and biopsies if needed every 3 months for 2 years, then every 6 months for an additional 2 years or until disease returns. The main outcomes measured include complete response rates at 11 and 24 weeks and event-free survival over 48 months, with ongoing safety monitoring during this period.

Researchers are conducting a global, multi-center, prospective post-market study to observe the long-term effectiveness of Boston Scientific neurostimulation systems in managing pain. The study aims to gather real-world clinical outcomes, economic value, and technical performance data of these commercially approved neurostimulation devices when used in routine clinical practice. The treatment involves an initial trial period using a Boston Scientific neurostimulation device for pain relief. Participants who experience a positive response during the trial may proceed to receive a permanent implant of the neurostimulation system. The therapy is tailored individually based on the investigator's judgment and standard care practices at each study site, following specific inclusion and exclusion criteria. Participants will be monitored throughout the trial and permanent implant phases to assess pain relief and overall treatment effectiveness. Assessments may include patient evaluations of pain and ability to complete study requirements. The study focuses on capturing comprehensive data to evaluate both clinical outcomes and device performance during regular use. Total participation duration depends on individual treatment progression from trial to permanent implant.

Bladder cancer is one of the most common malignancy worldwide, and non-muscle invasive (NMIBC) requires intensive regimens of frequent monitoring and local resection (transurethral resection of bladder \[TURBT\]). This study enrolls participants with non-muscle invasive or muscle invasive bladder cancer with activating fibroblast growth factor receptor (FGFR) mutations or fusions. Erdafitinib is a pan-FGFR inhibitor with demonstrated clinical activity when administered orally in patients with solid tumors, including bladder cancer, with FGFR genetic alterations. The Erdafitinib intravesical delivery system is designed to provide release of Erdafitinib in the bladder to treat localized bladder cancer, while reducing systemic toxicities. The study consists of a screening phase, a treatment phase, and a follow-up phase. Total duration of the study is approximately up to 7 years 4 months.