Jeffersonville

Researchers are evaluating PRL-02 depot, a potential injectable treatment for men with advanced prostate cancer whose cancer has returned after previous treatments or did not respond well. This phase 1 study aims to assess the safety, tolerability, and appropriate dosing of PRL-02 depot when given alone or with another medicine called enzalutamide. The study includes men with different types of metastatic prostate cancer, including castration-resistant and castration-sensitive forms, some of whom have previously taken specific hormone therapies. The study is conducted in two parts. In the first part, small groups of men receive increasing doses of PRL-02 depot along with other medicines like dexamethasone, prednisone, or enzalutamide depending on the group. In the second part, men who have taken hormone therapy abiraterone acetate or one other hormone therapy participate. All men receive PRL-02 depot injections into a muscle every 12 weeks and take daily oral medications as per their group assignment. Participants will visit the clinic regularly for health checks, scans, and laboratory tests to monitor safety and effectiveness. Researchers will track side effects, laboratory and heart monitoring results, performance status, and testosterone levels over up to four years. Men whose cancer does not worsen after the study will continue with periodic health assessments and scans. The total participation time varies based on individual response and study progression.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

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 the effectiveness of TAR-210 compared to a single-agent intravesical chemotherapy in adults with intermediate-risk non-muscle invasive bladder cancer (NMIBC) who have specific fibroblast growth factor receptor (FGFR) mutations or fusions. This phase 3 randomized study aims to compare disease-free survival between these treatments. Eligible participants must have a confirmed diagnosis of intermediate-risk NMIBC with certain risk factors and be willing to undergo multiple cystoscopies and assessments throughout the study. Participants will receive either TAR-210, which is delivered directly into the bladder, or one of the investigator-chosen intravesical chemotherapy drugs, including Gemcitabine or MMC, also administered into the bladder. Prior to randomization, visible tumors must be fully removed, and the absence of disease confirmed. The study includes a main study group and a substudy group with slightly different eligibility criteria based on tumor grade and risk factors. During the study, participants will be closely monitored through cystoscopies and surgical assessments (TURBT) to evaluate cancer recurrence or progression. The primary outcome measure is disease-free survival, tracked from randomization until the first documented cancer recurrence, progression, or death, over approximately four years and two months. Safety and treatment adherence will also be assessed throughout the study period.

Researchers are investigating the safety and effectiveness of TYRA-300 in adults with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC) that has specific FGFR3 gene changes. This Phase 2, open-label, multicenter study focuses on participants whose tumors have FGFR3 mutations or fusions and who have residual visible bladder tumors after prior surgery. It aims to assess how well TYRA-300 works in this group at 3 months after treatment begins. Participants will self-administer oral TYRA-300 tablets daily, with doses of 50mg or 60mg or a dose to be determined. The study does not include a placebo or other comparator groups. Treatment continues while participants are monitored for response and safety. The study includes careful eligibility screening to ensure participants meet specific tumor and health criteria, including no recent bladder cancer treatments or certain infections. During the study, participants will undergo regular evaluations including laboratory tests, imaging, and clinical assessments to monitor tumor response and safety. Researchers will track treatment effects and adverse events throughout the study. Participants must be able to swallow tablets and commit to contraception requirements if of childbearing potential. The total duration and follow-up details are based on treatment and safety monitoring schedules defined by the study protocol.

Researchers are studying immune response changes in men with metastatic castrate-resistant prostate cancer (mCRPC) who have been treated with PROVENGE® immunotherapy. This Phase 2, open-label, multicenter trial evaluates the effects of a single booster infusion of sipuleucel-T following the initial PROVENGE® treatment course. The study aims to measure the humoral immune response to specific prostate cancer antigens after this booster infusion. Participants will have previously completed three infusions of PROVENGE® before being randomized to receive one additional sipuleucel-T booster infusion. The intervention involves a single infusion of sipuleucel-T, which is designed to enhance the immune system's response against prostate cancer. This booster phase follows the initial PROVENGE® treatment. During the study, participants will be monitored through a five-year overall survival period, with assessments focused on the immune response to the treatment. Researchers will evaluate blood samples to measure antibody responses to PAP and PA2024 antigens after the booster infusion. The study involves ongoing safety and immune monitoring to understand the long-term effects of the booster treatment on this patient population.

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 Phase 2A/B, multi-center, open-label study to evaluate the effectiveness and safety of Dabogratinib (TYRA-300) in participants diagnosed with low grade upper tract urothelial carcinoma (LG UTUC) that is FGFR3 positive. The trial aims to assess the proportion of participants achieving a complete response within 6 months. Participants receive Dabogratinib orally in self-administered doses of 60mg or 80mg daily, with a possible dose to be determined for some. The study involves monitoring treatment impact and safety over the course of the trial. During the study, participants undergo genomic testing from archival, fresh tissue, or urine samples to confirm eligibility and monitor response. Researchers evaluate efficacy by measuring complete response rates within 6 months, along with safety assessments and laboratory tests to ensure adequate organ function throughout participation.

Researchers are evaluating the safety and initial antitumor effects of ORIC-944, an oral, selective small molecule inhibitor targeting the PRC2 complex, in patients with metastatic prostate cancer. The study is a first-in-human, open-label, multicenter phase 1/1b trial investigating ORIC-944 alone and combined with androgen receptor pathway inhibitors (ARPIs). The trial aims to establish safe dosing and explore preliminary effectiveness in this patient group. The study has three parts: Part I tests ORIC-944 alone through dose escalation; Part II combines ORIC-944 with ARPIs (such as abiraterone, apalutamide, darolutamide, or enzalutamide) to identify safe doses; Part III optimizes dosing for the combinations in two patient populations. Treatments are given orally and continuously, with different ARPI dosages depending on the drug used. The study evaluates two dose levels in combination with ARPIs to select the recommended phase 2 dose. Participants will undergo assessments including skin and tumor biopsies and regular monitoring of safety and drug levels. Researchers will measure pharmacokinetic outcomes like maximum plasma concentration and half-life, as well as clinical responses. The study includes follow-up to evaluate safety and preliminary antitumor activity over 12 months, with ongoing evaluation of drug exposure and effects.