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

Phase 2

Recruiting

• Conditions: Metastatic Castration-resistant Prostate Cancer (CRPC)
• Interventions: Drug: Immunotherapy; Drug: Targeted therapy; Device: Hyperthermia

• Registration Number: NCT06249750
• Lead Sponsor: Pengyuan Liu

Brief Summary

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.

Detailed Description

The initial efficacy and safety of the multimodal therapy will be evaluated at the animal level to fully validate the potential feasibility of the therapy. Subsequently, the efficacy of the multimodal therapy will be verified at the organoid level, and based on which a translational randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of the multimodal therapy at the human level, and the patients will be followed up for a long period of time, so as to collect detailed data on improvement of the quality of life. Finally, the synergistic effect of the multimodal therapy will be analyzed at the molecular and cellular levels.

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immuno-targeted therapy group	Immunotherapy	ICI regimen: Tislelizumab, 200mg, ivgtt., d1, q21d; RTK inhibitor regimen: Anlotinib, 12mg (at an initial dose of 12mg, later adjusted according to the instructions), po., d1\~14, q21d.
Hyperthermia-immuno-targeted therapy group	Immunotherapy	ET-SPACE near-infrared irradiation whole-body hyperthermia: d1, d8, q21d, rectal temperature reaches 38.5\~39 ℃ and then maintain 1h. ICI regimen: Tislelizumab, 200mg, ivgtt., d2, q21d; RTK inhibitor regimen: Anlotinib, 12mg (at an initial dose of 12mg, later adjusted according to the instructions), po., d2\~15, q21d.
Immuno-targeted therapy group	Targeted therapy	ICI regimen: Tislelizumab, 200mg, ivgtt., d1, q21d; RTK inhibitor regimen: Anlotinib, 12mg (at an initial dose of 12mg, later adjusted according to the instructions), po., d1\~14, q21d.
Hyperthermia-immuno-targeted therapy group	Targeted therapy	ET-SPACE near-infrared irradiation whole-body hyperthermia: d1, d8, q21d, rectal temperature reaches 38.5\~39 ℃ and then maintain 1h. ICI regimen: Tislelizumab, 200mg, ivgtt., d2, q21d; RTK inhibitor regimen: Anlotinib, 12mg (at an initial dose of 12mg, later adjusted according to the instructions), po., d2\~15, q21d.
Hyperthermia-immuno-targeted therapy group	Hyperthermia	ET-SPACE near-infrared irradiation whole-body hyperthermia: d1, d8, q21d, rectal temperature reaches 38.5\~39 ℃ and then maintain 1h. ICI regimen: Tislelizumab, 200mg, ivgtt., d2, q21d; RTK inhibitor regimen: Anlotinib, 12mg (at an initial dose of 12mg, later adjusted according to the instructions), po., d2\~15, q21d.

Primary Outcome Measures

Name	Time	Method
Biochemical objective response rate (BORR)	3 weeks	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%.

Secondary Outcome Measures

Name	Time	Method
Bio-Disease Control Rate （BDCR）	3 weeks	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%.

Trial Locations

Locations (1)

Zhejiang Hospital; 🇨🇳 Hangzhou, Zhejiang, China