The goal of this clinical trial is to explore the feasibility and the synergistic anti-cancer effect of high-intensity focused ultrasound (HIFU) combined with novel hormone therapy (NHT) in advanced prostate cancer (PCa). The main questions it aims to answer are: (1) whether could HIFU combined with NHT improve the long-term survival of patients with advanced PCa and alleviate local symptoms? (2) Does the synergistic effect of HIFU combined with NHT exist? Researchers will compare HIFU combined with NHT to NHT alone in advanced PCa patients. Participants will receive HIFU before NHT therapy or only receive NHT. In addition, participants are encouraged to record local symptoms condition and conduct regular follow-up.
An RCT study is conducted to include patients with advanced prostate cancer, who are randomly divided into two groups: the NHT alone group and the HIFU combined with NHT group. We compare the PFS after treatment to explore whether HIFU plus NHT improve the long-term survival and postpone progression. All patients will sign the informed consent form before enrollment and will be taken good care during study period. Patients will be screened according to the inclusion and exclusion criteria and will be given therapy according to randomization. Research data will be analyzed by a professional statistics team. The completion of the research will facilitate the expansion of HIFU into the comprehensive treatment of advanced PCa and will help improve the survival of such patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
The participants in the intervention arm will receive HIFU combined with standard NHT. Depending on the location of the lesion, tumor load and the pathological conditions, hemicglandular ablation or focal ablation was selectively administered. The safe boundary was set at 3mm, with a power of 300W and a pulse width of 30ms. Novel endocrine therapy was given after HIFU treatment
Participants in the control arm will receive standard NHT.
progression-free survival (PFS)
PFS refers to the time from the start of randomization to disease progression. Disease progression includes biochemical progression, clinical progression and imaging progression. Biochemical progression is defined as a PSA increase of more than 25% and an absolute increase of 2ng/ml compared to the baseline/minimum value. The definition of clinical progression is the emergence of any new clinical symptoms related to the primary disease and metastases of prostate cancer. The definition of imaging progression in imaging is the appearance of any new metastatic lesions.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 80 months
overall survival (OS)
It refers to the time from the start of randomization to death for any reason
Time frame: From date of randomization until the date of death from any cause, assessed up to 80 months
Time to castration resistance
Castration resistance is defined as : serum testosterone \<50 ng/dL or 1.7 nmol/L plus any one of the following: ① Biochemical progression: Three consecutive increases in PSA (at least one week apart), with two increases of 50% compared to the lowest value, and the absolute value \>2 ng/mL; ② Radiological progress: Two or more new bone metastases are found in imaging examinations such as bone scans, PET/CT, or one or more soft tissue lesions evaluated by the solid tumor response assessment criteria (RECIST 1.1 criteria, Appendix 1);
Time frame: the time from the start of randomization to the occurrence of castration resistance, assessed up to 80 months
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