Bone Metastasis

Researchers are evaluating a combination treatment for men with prostate cancer that has spread to other parts of the body and continued to grow despite treatments that lower male hormones. This phase I trial compares the effects of a radioactive drug called lutetium Lu 177 177Lu-PSMA-617 alone and combined with a vaccine therapy called Sipuleucel-T. The goal is to see if the combination can better stimulate the immune system and control the cancer. Participants are randomly assigned to one of two groups. One group receives 177Lu-PSMA-617 intravenously every 6 weeks for up to 6 cycles, while the other group receives the same radioactive drug plus Sipuleucel-T starting at week 8, given every 2 weeks for up to 3 doses. Both groups undergo various imaging scans such as PETCT, bone scans, MRI, and blood tests to monitor response and safety throughout the study. During the trial, patients have blood samples taken and may undergo leukapheresis removal of certain blood cells for vaccine preparation. They are followed closely with scans and clinical visits during treatment and after completion. Follow-up visits occur at 30 days, then every 3 months for up to a year, and every 6 months until disease progression. Researchers measure immune response, safety, tumor response, progression-free survival, and overall survival over up to 3 years of observation.

Researchers are evaluating the safety and effects of combining a targeted radionuclide therapy called 177Lu-PSMA-617 with liver-directed treatments in men who have metastatic castration-resistant prostate cancer mCRPC with liver metastases. This phase 1b open-label study focuses on patients whose cancer has progressed despite prior androgen pathway inhibitor treatments. The study aims to understand how well this combined approach controls disease and its safety profile using standard response criteria. Participants receive up to six cycles of 177Lu-PSMA-617 intravenously every 6 weeks. Those with PSMA-negative liver lesions receive a single session of liver-directed therapy such as transarterial chemoembolization TACE or ablation before starting the radionuclide treatment. If liver disease remains stable or progresses after two cycles, additional liver-directed therapy may be given. Treatment continues until disease progression, unacceptable side effects, or study completion. During the study, participants undergo imaging tests like PETCT scans, tumor biopsies, and complete questionnaires to assess responses. Researchers monitor safety through adverse event reports and measure outcomes such as objective response rates, progression-free survival, overall survival, and prostate-specific antigen PSA declines. Follow-up visits occur every 3 months for up to 5 years after the last treatment to track long-term effects.

Researchers are studying men with metastatic castration-resistant prostate cancer mCRPC to understand how different PETCT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PETCT scans at different times before starting LuPSMA radioligand therapy RLT, and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PETCT Axumin, 18F-DCFPyL PETCT, and 18F-FDG PETCT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PETCT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are evaluating the effectiveness of two diagnostic imaging methods, 68Ga-PSMA PET and Bone Scan, in detecting the progression of metastatic castration-resistant prostate cancer mCRPC in men aged 40 to 85. The study aims to compare how often each imaging tool identifies cancer progression and to explore relationships between PET tumor burden and certain blood markers. This is an open-label, single-arm clinical trial sponsored by Chang Gung Memorial Hospital. Participants will receive intravenous injections of a radioactive tracer called Ga68-PSMA-11, followed by PETCT scans performed on a specialized imaging system. Each participant undergoes a baseline PETCT scan before treatment and additional scans after the third and sixth injections of 223Ra-dichloride therapy. Bone scans are also done for comparison. The imaging and diagnostic results will be analyzed to assess differences in lesion detection between the two methods. During the study, participants will have blood tests, EKGs, and biochemistry assessments before and after their first PET scan. They will be monitored for any adverse events immediately following imaging. Experienced nuclear medicine physicians will interpret all images. The main outcome measured is the change in the number of detected lesions on PET imaging at approximately 9 to 23 weeks. Participants will be observed throughout the study, which continues until August 2025.

Researchers are studying whether 7 days of water-only fasting, a ketogenic very low-calorie diet, or ketone supplementation is safe and feasible for men with prostate cancer, including those with local and metastatic forms of the disease. Current immune-targeting treatments often do not work well for prostate cancer, and animal studies suggest that fasting or ketosis may help the immune system better attack cancer cells. Participants in this trial will be divided into groups based on their cancer type and intervention. Some will follow a 7-day water-only fast followed by a 3-day refeeding period, while others will take a ketone supplement for 7 days. These interventions are being tested for safety and feasibility in both local and metastatic prostate cancer. During the study, participants will be monitored for adverse events and their ability to complete the fasting or supplementation. Quality of life and physical activity will be assessed daily using surveys and step counts from Day 1 to Day 10. Biopsies may be required depending on cancer status. The study will last about 10 days for each participant, with safety and outcomes followed for up to one year.

Researchers are evaluating KTX-2001 alone and in combination with darolutamide in men with metastatic castration-resistant prostate cancer mCRPC. This first-in-human, open-label Phase 1 study aims to assess the safety, dosage levels, and preliminary effectiveness of KTX-2001. The study also examines how these drugs behave in the body, intending to establish recommended doses for future research. Participants will receive escalating doses of KTX-2001 either alone or combined with darolutamide, an oral androgen receptor pathway inhibitor given at 600 mg twice daily total 1200 mg. The study has two parts Part A tests KTX-2001 monotherapy, and Part B tests KTX-2001 with darolutamide. Dose escalation occurs sequentially to determine the maximum tolerated dose and recommended Phase 2 dose. Participants will be monitored closely for dose-limiting toxicities over 21 days and overall safety up to three years. Assessments include pharmacokinetic measurements of drug concentrations in plasma and regular evaluations of health and side effects. Tissue biopsies of metastatic sites may be collected if safe and feasible. The study will continue until September 2028, with ongoing safety and efficacy follow-up throughout this period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor effects of QLC5508 and QLH12016 combined with other anti-tumor therapies in men with advanced prostate cancer. This open-label, multicenter Phase IbII trial aims to find the best dose and explore how well these combinations work, especially in patients with metastatic disease and castrate-resistant prostate cancer. The study has two stages Phase Ib involves carefully increasing doses of these drugs to determine the recommended Phase II dose, while Phase II focuses on assessing their therapeutic effects at that dose. Participants may receive QLC5508 by injection, and oral medications including abiraterone, enzalutamide, and QLH12016 in various combinations as specified in the protocol. Participants will be evaluated throughout the study with blood tests for genetic mutation analysis, monitoring for side effects, and assessments of prostate-specific antigen PSA response and tumor response over about one year. Safety, tolerability, and pharmacokinetics will be closely observed during Phase Ib, while Phase II will measure effectiveness through PSA50 response and objective response rate. The study is expected to continue until late 2027.

Researchers are investigating a novel autologous T-cell therapy called CC-38 for patients with metastatic colorectal cancer and metastatic prostate cancer. These cancers have not been extensively studied with T-cell therapies before. The trial aims to evaluate whether repeated administration of this personalized therapy can increase the persistence of tumor-infiltrating lymphocytes TILs in the bloodstream, potentially improving tumor infiltration by these immune cells. The investigational treatment, CC-38, is a personalized therapy made from the patients own tumor-infiltrating lymphocytes expanded in the lab. Patients will receive repeated doses of CC-38 along with supportive medications including pembrolizumab, cyclophosphamide, interleukin-2, and uromitexan. The study is an open-label, single-group trial assessing the safety, tolerability, and feasibility of this novel treatment over an extended period. Participants will be closely monitored throughout the study for safety and treatment effects over 42 months. Assessments include imaging to confirm disease progression, pathological evaluation of tumor tissue, and laboratory tests to evaluate organ function and immune response. The primary outcome is safety and feasibility, while secondary outcomes focus on the treatments efficacy. Follow-up visits and evaluations will track patients health and response to therapy during and after treatment.

Researchers are investigating real-world outcomes for patients with symptomatic, high-risk bone metastases who receive both percutaneous ablation and palliative radiation therapy. The study aims to understand effects on pain, patient-reported outcomes, skeletal events, and healthcare use in this population. This observational trial is sponsored by the Society of Interventional Oncology and focuses on adults aged 21 and older with bone metastatic cancer. The study observes patients treated with percutaneous ablation, a minimally invasive method targeting pain-causing nerves and tumor tissues, alongside radiation therapy, which is commonly used to relieve pain from bone metastases. Treatments are given under specialists review, ensuring lesions are suitable for both procedures. No prior targeted radiation or ablation should have been performed on the lesion to be studied. Participants will be monitored over time through patient-reported outcome surveys like PROMIS, BPI, COST-FACIT, and OMED for up to 12 months. The primary measure is pain response assessed at three months following treatment. The study also tracks safety, skeletal related events, and healthcare usage, with follow-up focused on those with a life expectancy greater than three months and an ECOG performance status of 0-2.

Researchers are evaluating the safety and preliminary efficacy of OM-RCA-01, a monoclonal antibody targeting fibroblast growth factor receptor 1 FGFR1, in patients with metastatic solid tumors that express FGFR1. This Phase 1b2, multicenter, open-label study uses a basket trial design enrolling patients regardless of tumor type, focusing on cancers such as renal cell carcinoma, non-small cell lung cancer, head and neck cancer, breast cancer, and prostate cancer. The study aims to understand the medical issues participants may experience, determine appropriate dosing for future studies, and assess whether tumor growth slows with treatment. All participants will receive OM-RCA-01 through an intravenous infusion every two weeks. Treatment will continue as long as the disease remains controlled and the drug is well tolerated. The study includes five tumor-specific groups and plans to enroll 58 patients. The drug is given at dose levels of 50 mg or 100 mg, and therapy will proceed until disease progression or unacceptable toxicity occurs. Participants will be monitored through regular assessments including imaging to measure tumor lesions, laboratory tests for organ function, and questionnaires to evaluate quality of life. Safety will be closely observed by tracking adverse events, serious side effects, and the presence of anti-drug antibodies. The study will follow patients for up to 12 months to evaluate outcomes such as progression-free survival, overall survival, and duration of response.