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

ConditionMetastatic Castration-resistant Prostate Cancer (CRPC)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexMale

Age18-90

SponsorPengyuan Liu

About this trial

In this study, we propose to use the combination of ET-SPACE NIR irradiation whole-body thermal stimulation, ICI (Tislelizumab), and RTK inhibitor (Anlotinib) in the multimodal treatment of CRPC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Immunotherapy
Drug
Immunotherapy is currently a hot spot in the field of tumor research. Immune Checkpoint Inhibitor (ICI) is a monoclonal antibody designed to target the negative immunoregulatory pathway overexpressed in tumor cells, which can release the anti-tumor immunosuppressive signals and restore the killing of tumors by the immune cells, and thus exert anti-tumor effects. ICI regimen: Tislelizumab, 200mg, ivgtt., d1, q21d.
Targeted therapy
Drug
Recent studies have found that the combination of RTK inhibitors and ICIs can exert synergistic effects on different mechanisms, which can compensate for the deficiencies of single-agent RTK inhibitors and single-agent ICIs in the treatment of CRPC and become a potential novel therapeutic strategy for solid malignant tumors. RTK inhibitor regimen: Anlotinib, 12mg, po., d2\~15, q21d.
Hyperthermia
Device
Thermal stimulation is a rapidly developing physiotherapeutic tool, which is playing an increasingly important role in the field of comprehensive tumor therapy due to its unique low adverse effects and high compatibility. A large number of clinical studies have shown that the addition of heat stress to multimodal tumor therapy does not significantly increase toxicity and side effects, and the combination of heat stress with other therapies can have the effect of "1+1\>2". ET-SPACE near-infrared irradiation whole-body hyperthermia: d1, d8, q21d, rectal temperature reaches 38.5\~39 ℃ and then maintain 1h.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Immuno-targeted therapy groupExperimental treatment 2 interventions

Group B: Hyperthermia-immuno-targeted therapy groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Biochemical objective response rate (BORR)

Detect blood PSA levels before and during treatment, compare baseline and post treatment PSA difference levels, and evaluate efficacy. Bio Complete Response (BCR): PSA remains normal or decreases to normal (4ng/mL) for at least 3 weeks. Partial Biochemical Response (BPR): PSA decreased by ≥ 50% from baseline and maintained for at least 3 weeks. BPRR=BCR+BPR/All patients × 100%.

Time frame

3 weeks

Secondary outcomes

Bio-Disease Control Rate （BDCR）

Bio Complete Response (BCR): PSA remains normal or decreases to normal (4ng/mL) for at least 3 weeks. Partial Biochemical Response (BPR): PSA decreased by ≥ 50% from baseline and maintained for at least 3 weeks. Bio Progression Disease (BPD): PSA increased by ≥ 25% from baseline. BDCR=BCR+BPR+BPD/All patients × 100%.

Time frame

3 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pengyuan Liu

Lead sponsor

Zhejiang Hospital

Sponsor institution

Source ClinicalTrials.gov

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