Clinical Research Directory

PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer

PRO-BOOST-LC is a prospective, multicenter, randomized clinical trial designed for patients with localized prostate cancer who do not have evidence of lymph node or distant metastases based on modern PSMA PET imaging. Prostate cancer is one of the most common cancers in men. For patients with disease confined to the prostate, radiotherapy is a well-established and effective curative treatment option. Over the past decades, research has shown that delivering higher radiation doses to the prostate can improve cancer control and reduce the risk of disease recurrence. However, higher radiation doses may also increase the risk of side effects affecting urinary, bowel, and sexual function. For this reason, different radiation techniques have been developed to safely deliver higher doses while protecting surrounding healthy organs. Several approaches to radiation dose escalation are currently used in clinical practice. These include stereotactic body radiotherapy (SBRT), which delivers radiation in a small number of highly precise treatments, as well as brachytherapy, where radioactive sources are placed directly inside the prostate for a short time (high-dose-rate brachytherapy) or permanently (low-dose-rate brachytherapy). Although all these approaches are accepted and widely used, it is not known which strategy provides the best balance between cancer control, treatment-related side effects, and long-term quality of life, particularly when modern imaging techniques are used to accurately stage the disease. The PRO-BOOST-LC study aims to directly compare different radiation dose escalation strategies using a standardized treatment framework. All participants enrolled in the study will have localized prostate cancer staged with PSMA PET imaging to exclude metastatic disease. Participants will then be randomly assigned to one of four treatment groups. One group will receive SBRT alone to the prostate. The other three groups will receive a short course of external beam radiotherapy followed by an additional focused radiation boost delivered using one of three methods: high-dose-rate brachytherapy, low-dose-rate brachytherapy, or SBRT. All treatment approaches used in this study are established methods routinely applied in clinical practice. Randomization ensures that each participant has an equal chance of being assigned to any of the treatment groups. This allows the study to fairly compare outcomes between the different strategies. The main objective of the trial is to determine whether adding a radiation boost improves treatment outcomes compared with SBRT alone. The primary outcome measure is failure-free survival, which includes cancer recurrence, disease progression, the need for additional cancer treatment, or death from any cause. Secondary outcomes include the development of distant metastases, overall survival, treatment-related side effects, and patient-reported quality of life. Participants will be closely monitored throughout the study. Before treatment, patients will undergo clinical evaluation, blood tests including prostate-specific antigen (PSA), imaging studies, and quality-of-life assessments. During and after treatment, participants will attend regular follow-up visits. These visits will include clinical examinations, PSA testing, assessment of treatment-related side effects, and completion of standardized questionnaires evaluating urinary, bowel, and sexual function, as well as overall quality of life. Imaging studies, including PSMA PET scans, will be performed when clinically indicated to assess for possible disease recurrence or progression. The study is designed to follow participants for many years in order to capture both early and long-term outcomes. By using modern radiotherapy techniques, standardized treatment protocols, and comprehensive follow-up, PRO-BOOST-LC aims to generate high-quality evidence that will help guide future treatment decisions for patients with localized prostate cancer. The results of this trial are expected to improve understanding of how best to use radiation dose escalation to maximize cancer control while minimizing side effects and preserving quality of life in the era of advanced imaging and precision radiotherapy. Participation in this study does not involve experimental or unproven treatments. All radiation techniques used in PRO-BOOST-LC are approved, widely available, and considered standard of care in many treatment centers worldwide. The study focuses on optimizing how these existing techniques are combined and delivered, rather than introducing new drugs or devices. Participation may involve additional follow-up assessments and questionnaires compared with routine care, but treatment decisions are made within established clinical practice guidelines. Patients may or may not directly benefit from participation, but the information gained from this study may help improve future treatment strategies for men with localized prostate cancer.

PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer

Patients with prostate cancer and pelvic lymph node involvement (cN1M0) identified on PSMA PET imaging represent a biologically aggressive yet potentially curable disease population. Contemporary management relies on multimodality treatment combining definitive radiotherapy to the prostate and pelvic lymph nodes with long-term androgen deprivation therapy (ADT), often intensified with androgen receptor pathway inhibitors. Despite these advances, a substantial proportion of patients still develop distant metastatic disease, highlighting the need to optimize local-regional treatment strategies in the era of molecular imaging. The introduction of PSMA PET has fundamentally altered staging accuracy in prostate cancer, enabling earlier and more precise detection of pelvic nodal disease. However, most existing evidence guiding radiotherapy dose prescription in node-positive prostate cancer originates from the pre-PSMA era. As a result, it remains unclear how best to integrate prostate-directed and nodal-directed dose escalation strategies when disease extent is defined by modern molecular imaging. In particular, it is unknown whether long-term disease control is primarily driven by durable intraprostatic tumor eradication, by aggressive treatment of involved lymph nodes, or by a combination of both. PRO-BOOST-N is a prospective, multicenter, randomized phase II/III clinical trial designed to address this critical evidence gap. The trial evaluates prostate-first versus combined prostate and nodal dose escalation strategies in patients with PSMA PET-staged node-positive (cN1M0) prostate cancer treated within a standardized ultrahypofractionated whole-pelvis radiotherapy framework. All enrolled patients indicated for definitive treatment undergo mandatory baseline PSMA PET/CT to confirm pelvic lymph node involvement and exclude distant metastatic disease. All patients receive a uniform radiotherapy backbone consisting of ultrahypofractionated whole-pelvis radiotherapy delivered in five fractions, combined with long-term ADT. Use of androgen receptor pathway inhibitors is permitted and encouraged according to contemporary clinical practice and local availability, ensuring the relevance of the trial to real-world treatment settings. Using a 2×2 factorial randomized design, PRO-BOOST-N evaluates two independent treatment factors. The primary randomized comparison assesses whether ablative prostate dose escalation improves oncologic outcomes compared with contemporary SBRT-based definitive prostate radiotherapy without additional boost. Prostate dose escalation may be delivered using one of three protocol-defined modalities-high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT-according to institutional expertise. This comparison directly tests the hypothesis that durable intraprostatic disease control is the dominant determinant of long-term systemic disease suppression in node-positive prostate cancer. The key secondary, hierarchically tested comparison evaluates the role of nodal dose escalation by comparing two predefined dose levels delivered to PSMA PET-positive pelvic lymph nodes. These dose levels reflect intermediate versus higher nodal boost strategies based on biologically effective dose concepts specific to prostate cancer radiobiology. To ensure patient safety and protocol feasibility, organ-at-risk-driven nodal dose de-escalation is permitted within the higher-dose arm, without altering randomization assignment. The primary endpoint of the trial is metastasis-free survival. Secondary endpoints include overall survival, radiographic progression-free survival assessed primarily using PSMA PET imaging, intraprostatic and regional nodal control, time to castration-resistant prostate cancer, time to next systemic therapy, treatment-related toxicity graded according to CTCAE version 5.0, and patient-reported outcomes assessing urinary, bowel, sexual, and global quality of life. By prospectively and hierarchically evaluating prostate and nodal dose escalation strategies within a modern PSMA PET-guided and ultrahypofractionated radiotherapy platform, PRO-BOOST-N aims to define the optimal radiotherapy intensification approach for patients with node-positive prostate cancer. The results of this study are expected to directly inform clinical practice, guideline development, and future treatment individualization in the PSMA PET era.

The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer

Introduction: Immunotherapy in combination with chemotherapy have been recommended as the first-line treatment of driver-negative advanced non-small cell lung cancer (NSCLC), but the efficacy is worse in NSCLC patients with bone metastases due to the immunosuppressive microenvironment. Studies have shown that not only the nuclear factor kappa-B ligand (RANKL) inhibitors but also Stereotactic Body Radiation Therapy (SBRT) play a significant role in improving the tumor immune microenvironment. Therefore, narlumosbart，a monoclonal antibody (mAb) targeting RANKL，in combination with SBRT may have synergistic effects and improve efficacy of immunotherapy and chemotherapy in driver-negative advanced NSCLC patients with bone metastases. Methods: This single-arm, single-center phase II clinical trial will enroll NSCLC patients with bone metastases who have not received any systemic therapy. Patients will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg/time, subcutaneous injection, is administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy/3F is used for spinal metastases, and 30Gy/5F or 35Gy/5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy was used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include progression-free survival, overall survival and safety. Sample size calculation used the Simon Two-Stage method. 9 patients will be enrolled in the first stage. If ≥ 2 patients achieve CR/PR, the second stage of enrollment will be performed. If only 2 patients \< achieve CR/PR, the trial will be terminated. In the second phase, 15 patients will be enrolled. 27 subjects will be enrolled in this project, considering the dropout rate of 10%. Wangjun Yan AND Zhengfei Zhu are the Co-Principal Investigators of this study.

Practical Geriatric Assessment in Older Adults With Non-Small Cell Lung Cancer Undergoing Stereotactic Body Radiation Therapy

National guidelines recommend that older adults with cancer undergo a special health assessment before starting cancer treatment. This type of assessment evaluates physical function, nutrition, social support, psychological well-being, medical conditions (both cancer-related and non-cancer-related), and cognitive function. The results can help doctors make better treatment decisions and determine whether additional support services-such as nutrition counseling, physical therapy, or social work-would be beneficial. Even though these assessments are recommended, they are not typically used because they need to be performed by a specialist and can take over an hour to complete. Given these challenges, a 10-15-minute assessment called the Practical Geriatric Assessment (PGA) was recently developed. The PGA can be completed by any healthcare provider and helps identify older adults who may need extra support alongside their cancer treatment. While the PGA has the potential to make geriatric assessments more accessible, the investigators do not yet know whether patients will find it useful or easy to complete. Additionally, it is unclear whether using the PGA will lead to more referrals for recommended supportive care services. This study aims to address these questions. The investigators will evaluate whether using the PGA impacts the number of patients referred to recommended supportive care services. Investigators will also evaluate how participants feel about completing the PGA, including how easy or difficult it is, and to assess the feasibility of implementing this survey on a larger scale. Finally, the investigators will use facial photographs and audio-visual data from the PGA to develop and evaluate artificial intelligence algorithm(s) to identify vulnerable patients who might benefit from additional supportive care services; namely, FaceAge, a validated deep learning model capable of estimating biological age from still facial images.

Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases

Current guidelines suggest postoperative spine Stereotactic Body Radiation Therapy (SBRT) should be delivered within 2-4 weeks after surgery. This approach is rife with logistical complications that create delays and barriers for patients accessing care. An alternative approach delivers postoperative spine SBRT soon after surgery, starting within a single hospital stay. This study will investigate the effects of short-term postoperative spine SBRT on wound complications in a safety lead-in, then will transition to a phase 2 trial investigating local tumor control.

SMC Radiation Oncology SABR Cohort for Oligometastasis

The goal of this observational study is to evaluate the efficacy and safety of stereotactic body radiotherapy (SABR) in patients with oligometastatic or oligoprogressive cancer. The main questions it aims to answer are: 1. oncologic outcomes (progression-free survival, local failure rate), 2. patient-reported outcomes, 3. physician-assessed toxicity, and 4. dynamics of circulating tumor DNA (ctDNA) for biomarker analysis.

Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia

The aim of the study is to compare the efficacy and safety of treating recurrent sustained Ventricular Tachycardia (sVT) after prior Catheter Ablation (CA) in patients with Implanted Cardioverter-Defibrillator (ICD) between re-do of conventional endocardial CA and Stereotactic Arrhythmia Radioablation (STAR).

Chemoimmunotherapy With or Without SBRT Before Surgery for Locally Advanced Oral and Oropharyngeal Cancer

In this study, participants will be randomly assigned to either the experimental group or the control group. The experimental group will first receive SBRT (6Gy\*3 fractions) to treat the primary tumor and metastatic lymph nodes. This will be followed by a combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks. The control group will receive the same combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks, but without SBRT. After the final round of chemotherapy, all participants will have imaging scans and, three weeks later, undergo surgery. After surgery, they may also receive additional radiotherapy with or without chemotherapy. Patients can also choose whether to continue treatment with Toripalimab after surgery.