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 (177^Lu)-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 177^Lu-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 PET/CT, 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 PET/CT 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 PET/CT 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 PET/CT 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 PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. 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 PET/CT 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 PET/CT scans performed on a specialized imaging system. Each participant undergoes a baseline PET/CT 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 investigating whether 7 days of water-only fasting or a very low-calorie ketogenic diet is safe and doable for men with metastatic prostate cancer. Current immune-targeting treatments have limited success for this cancer, and animal studies suggest fasting may help the immune system better target cancer cells. This study aims to gather information to guide future research on integrating fasting or diet approaches into prostate cancer treatment plans. Participants will undergo a 7-day water-only fast, followed by a 3-day period of refeeding. If needed, they can switch to a ketogenic very low-calorie diet during the fasting period. The study focuses on safety and feasibility for men with metastatic prostate adenocarcinoma, with careful monitoring through regular laboratory tests and a clinic visit on Day 3. Throughout the study, participants will have their health and quality of life assessed using surveys and step counts from Day 1 to Day 10. Adverse events will be recorded over one year to evaluate safety. The study lasts about 10 days of active participation, with follow-up to track how many complete the fasting or diet and any related side effects.

Researchers are evaluating KTX-2001, alone and in combination with darolutamide, in men with metastatic castration-resistant prostate cancer (mCRPC). This first-in-human Phase 1 clinical trial aims to study the safety, how the drug behaves in the body, and its initial effectiveness in treating mCRPC. The goal is to find safe dose levels and understand how KTX-2001 works with darolutamide, an oral androgen receptor pathway inhibitor. Participants will receive escalating doses of KTX-2001 either by itself or combined with darolutamide taken orally at a dose of 600 mg twice a day (total 1200 mg daily). The study has two parts: Part A tests KTX-2001 alone, and Part B tests the combination with darolutamide. Doses will increase to assess tolerance and safety, with treatment given continuously during the study periods. During the trial, participants will have regular assessments including biopsies of metastatic sites when possible, blood tests to monitor safety and drug levels, and scans to confirm metastatic disease. Researchers will track dose-limiting toxicities over 21 days to determine maximum tolerated doses and monitor adverse events for up to three years. The study team will also evaluate pharmacokinetics and recommend doses for future studies, with total participation lasting up to about three years.

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 Ib/II 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 studying the safety and effectiveness of a modified herpes simplex virus called R130 for treating advanced bone and soft tissue tumors, including osteosarcoma and sarcoma. This early-phase, open-label clinical trial aims to learn how this oncolytic virus works in patients who have relapsed or refractory tumors and have not responded to standard treatments or choose not to receive other therapies. Participants will receive injections of 1 to 2 ml of R130, containing 1x10^8 plaque-forming units per milliliter, directly into their tumors every 7 to 14 days. The treatment focuses on patients with measurable lesions suitable for direct injection. This single-arm study does not include a comparison group and is sponsored by Shanghai Yunying Medical Technology. During the study, patients will be closely monitored for adverse events and laboratory changes up to 6 months after treatment. Researchers will assess immune responses, disease control, duration of response, and quality of life over a 12-month period with scheduled evaluations every 6 to 10 weeks. Participants must meet certain health and organ function requirements and will be followed for safety and outcomes throughout the trial.

Researchers are evaluating a new immunotherapy treatment using tumor-infiltrating lymphocytes (TIL) for patients with metastatic colorectal cancer or metastatic prostate cancer. This first-in-human trial aims to study the safety, tolerability, and feasibility of repeatedly administering this novel TIL-based therapy called CC-38. The study seeks to improve long-term persistence of TILs in the bloodstream, potentially enhancing tumor infiltration. These cancers have not been extensively studied with T-cell therapies before. The treatment involves an advanced therapy investigational medicinal product (ATIMP) made from a patient's own expanded TILs, referred to as CC-38. Alongside CC-38, patients may receive other drugs including pembrolizumab, cyclophosphamide, interleukin-2, and uromitexan as part of the therapeutic regimen. The study is open-label and includes repeated administrations of this personalized TIL therapy. The trial monitors the treatment's safety and feasibility over a period of 42 months. Participants will be closely monitored throughout the trial with regular assessments including imaging studies to confirm disease progression and measure tumor response. Researchers will evaluate safety, tolerability, and treatment feasibility as primary outcomes, along with efficacy as a secondary outcome. Patients will provide tumor tissue samples for TIL expansion and undergo various clinical and laboratory tests. The total study duration for outcome evaluation is 42 months, ensuring long-term follow-up and safety monitoring.

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.