Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 90 Men only

Using heat and targeted therapies to treat advanced prostate cancer

Official title: Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer

Run by Zhejiang Hospital · NCT06249750 · Data updated 2026-11-12

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.

More Metastatic Castration-resistant Prostate Cancer trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 90 Years
SexMen only
Enrollment60 (estimated)
SponsorZhejiang Hospital
Academic / other
Drugs / interventionsTislelizumab, Anlotinib
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedJanuary 1, 2024
Main results expectedDecember 31, 2024
Study endsDecember 31, 2026
Registry record updatedFebruary 8, 2024
Trial IDNCT06249750 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 to 90 with confirmed metastatic castration-resistant prostate cancer and good overall health.

Probably not a fit

Patients with severe underlying health conditions or those unable to tolerate systemic heat stress may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While the combination of these specific therapies is novel, similar multimodal approaches have shown promise in other studies.

Who can join: the full rules

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 it's running

  • Zhejiang Hospital
    Hangzhou, Zhejiang, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • New ACK1-blocking pill (R)-9bMS for advanced prostate cancer

    This phase 1 trial will test whether the oral ACK1 inhibitor (R)-9bMS is safe and tolerable in men with metastatic castration-resistant prostate cancer who no longer respond to enzalutamide or abiraterone.

    Recruiting Phase 1 TechnoGenesys, Inc. · Madison, Wisconsin · NCT06705686

  • JANX013 and JANX007 combo in advanced prostate cancer

    A first-in-human study will test JANX013 together with JANX007 to see if this combination is safe and tolerable in adults with metastatic castration-resistant prostate cancer.

    Recruiting Phase 1 Janux Therapeutics · Nashville, Tennessee · NCT07813637

  • MRT-2359 plus apalutamide in advanced prostate cancer

    This Phase 2 trial tests whether taking MRT-2359 with apalutamide can lower PSA in men with castration-resistant prostate cancer.

    Recruiting at 7 sites Phase 2 Monte Rosa Therapeutics, Inc · Los Angeles, California and 13 other locations · NCT07745361

  • 177Lu-BetaBart treatment for relapsed, inoperable, or metastatic solid tumors

    This trial will test a radioactive antibody called 177Lu-BetaBart in adults whose solid tumors have progressed after prior treatment, including castration-resistant prostate, colorectal, lung, ovarian, or cervical cancer.

    Recruiting at 5 sites Phase 1/2 Radiopharm Theranostics, Ltd · Dothan, Alabama and 4 other locations · NCT07189871

  • JUR-003 in adults with advanced prostate cancer

    This first-in-human study tests JUR-003 to see if it is safe and tolerable and to get an early sense of activity in adults with metastatic or advanced prostate cancer.

    Recruiting at 4 sites Phase 1 TCG Labs Soleil · Grand Rapids, Michigan and 3 other locations · NCT07824349

  • SRT-017 radioligand therapy in PSMA-positive metastatic castration-resistant prostate cancer

    This study tests SRT-017 given by IV infusion to men with PSMA-positive metastatic castration-resistant prostate cancer to see if it is safe and tolerable and to gather early signals of anti-tumor activity.

    Recruiting Early Phase 1 Affiliated Hospital of Jiangnan University · Wuxi, Jiangsu · NCT07798778

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.