The goal of this clinical trial is to explore whether androgen deprivation therapy combined with novel androgen receptor inhibitors, prostate cryoablation, and metronomic cyclophosphamide is superior to the current treatment regimen of androgen deprivation therapy plus novel androgen receptor inhibitors for patients with metastatic prostate cancer. It will also learn about the safety of prostate cryoablation, and metronomic cyclophosphamide for patients with metastatic prostate cancer. The main questions it aims to answer are: Does prostate cryoablation, and metronomic cyclophosphamide delay the progression of metastatic prostate cancer? Does prostate cryoablation, and metronomic cyclophosphamide reduce symptomatic local events of metastatic prostate cancer? Researchers will explore if androgen deprivation therapy combined with novel androgen receptor inhibitors, prostate cryoablation, and metronomic cyclophosphamide works to treat metastatic prostate cancer. Participants will: Receive treatment of androgen deprivation therapy and novel androgen receptor inhibitors until progression. Receive prostate cryoablation surgery and take cyclophosphamide. Visit the clinic every 1-3 months for checkups and tests. Keep a diary of their symptoms.
This study aims to evaluate the efficacy and safety of combining prostate cryoablation and cyclophosphamide with androgen deprivation therapy plus novel androgen receptor inhibitors (apalutamide, rezvilutamide, or darolutamide) in patients with newly diagnosed, metastatic prostate cancer. By comparing with previous studies, it seeks to explore whether prostate cryoablation and cyclophosphamide treatment can confer survival benefits and reduce symptomatic local urinary events in these patients. Patients with newly diagnosed, metastatic prostate cancer who meet the inclusion criteria after evaluation will receive treatment with androgen deprivation therapy plus a novel androgen receptor inhibitor (apalutamide, rezvilutamide, or darolutamide) in combination with prostate cryoablation and cyclophosphamide. Enrolled patients should start the novel androgen receptor inhibitor (apalutamide, rezvilutamide, or darolutamide) within 3 months of initiating androgen deprivation therapy and undergo prostate cryoablation within 6 months of starting androgen deprivation therapy. Cyclophosphamide treatment will begin one day after prostate cryoablation and continue for a total of six months. The primary endpoint of the study is PSA progression-free survival. Secondary endpoints include: 1) radiographic progression-free survival, 2) time to progression to metastatic castration-resistant prostate cancer, 3) overall survival, 4) PSA nadir, 5) incidence of symptomatic local events, and 6) safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Enrolled patients will receive prostate cryoablation within 6 months of starting androgen deprivation therapy.
Enrolled patients will receive cyclophosphamide (50mg daily) one day after prostate cryoablation and continue for a total of six months.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGPSA progression-free survival
Defined as the time from the initiation of androgen deprivation therapy to the occurrence of PSA progression or death.
Time frame: From date of initiation of androgen deprivation therapy until the date of PSA progression or date of death from any cause, whichever came first, assessed up to 5 years
Radiographic progression-free survival
Defined as the time from the initiation of androgen deprivation therapy to the occurrence of radiographic progression of death.
Time frame: From date of initiation of androgen deprivation therapy until the date of radiographic progression or date of death from any cause, whichever came first, assessed up to 5 years
mCRPC-free survival
Defined as the time from the initiation of androgen deprivation therapy to progression to metastatic castration-resistant prostate cancer (mCRPC) or death.
Time frame: From date of initiation of androgen deprivation therapy until the date of progression to metastatic castration-resistant prostate cancer or date of death from any cause, whichever came first, assessed up to 5 years
Overall survival
Defined as the time from the initiation of androgen deprivation therapy to death from any cause.
Time frame: From date of initiation of androgen deprivation therapy until the date of death from any cause, assessed up to 5 years
Incidence of symptomatic local events
Symptomatic local events are defined as any of the following conditions: urinary tract infection, indwelling catheterization, acute kidney injury, transurethral resection of the prostate, urinary obstruction, indwelling ureteral stent placement, nephrostomy, colostomy, or surgery for intestinal obstruction.
Time frame: Through study completion, an average of 3 year
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