Using heat and targeted therapies to treat advanced prostate cancer
Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer
This study is testing a new treatment for advanced prostate cancer that uses heat therapy along with two medications to see if it helps patients feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | Zhejiang Hospital Academic / other |
| Drugs / interventions | Tislelizumab, Anlotinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06249750 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel multimodal treatment approach for metastatic castration-resistant prostate cancer (CRPC) that combines near-infrared whole-body thermal stimulation, an immune checkpoint inhibitor (Tislelizumab), and a targeted therapy (Anlotinib). Initially, the efficacy and safety of this combination will be assessed in animal models, followed by organoid studies to validate its feasibility. A randomized controlled clinical trial will then evaluate the treatment's effectiveness and safety in human patients, with long-term follow-up to gather data on quality of life improvements. The study will also analyze the synergistic effects of the therapies at molecular and cellular levels.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 90 with confirmed metastatic castration-resistant prostate cancer and good overall health.
Not a fit: Patients with severe underlying health conditions or those unable to tolerate systemic heat stress may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes and quality of life for patients with advanced prostate cancer.
How similar studies have performed: While the combination of these specific therapies is novel, similar multimodal approaches have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histopathologically confirmed diagnosis of PC and clinically confirmed diagnosis of CRPC; * Complete and reliable medical history and medical records; * No other primary tumors except CRPC; * Blood tests, liver function, renal function and electrocardiogram are basically normal; * Patients with ECOG score 0\~3, aged ≥18 years and \<90 years old; * Patients with good compliance, able to accept regular follow-up. Exclusion Criteria: * History of malignant tumor other than PC within the past 5 years; * Severe abnormalities in the patient's laboratory indices may jeopardize patient safety or compromise this study; * Accompanied by severe underlying diseases that cannot tolerate this therapy; * With acute diseases, such as acute infection, active bleeding; * Those who have recently participated in other clinical trials and have not passed the washout period; * Those who cannot tolerate systemic heat stress, such as claustrophobic patients; * Those who have a history of allergy to the drugs used in the trial; * Patients with other reasons for not being able to be enrolled in the study, according to the study doctor.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Pengyuan Liu
- Email: oncologyliupengyuan@outlook.com
- Phone: 18368846455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.