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RECRUITING Phase 2 ClinicalTrials.gov

Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer

Sponsor: Sun Yat-sen University • ClinicalTrials.gov ID: NCT06854250

Registry updated: 2026-08-28
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Description

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.

Interventions

  • Prostate cryoablation (Procedure)
    Enrolled patients will receive prostate cryoablation within 6 months of starting androgen deprivation therapy.
  • Cyclophosphamide (CTX) (Drug)
    Enrolled patients will receive cyclophosphamide (50mg daily) one day after prostate cryoablation and continue for a total of six months.

Eligibility criteria

Inclusion Criteria: * Males between 18 and 80 years old; * Histopathological confirmation of prostatic acinar adenocarcinoma; * Diagnosed with metastatic prostate cancer at initial diagnosis according to the AJCC 8th edition staging criteria; * No progression at the time of initiating of prostate cryoablation; * ECOG score of 0-1; * Can tolerate general anesthesia and prostate cryoablation surgery; * No significant abnormalities . * Able to understand this study and sign the informed consent form. Exclusion Criteria: * Serious illness not suitable to receive the treatment regimen; * Other malignant tumors (within 5 years), except for non-melanoma skin cancer; * Receipt of treatments other than treatment regimen of this study; * Prostate cancer invading the rectum; * with prostate volumegreater than 55ml after 6 months of androgen deprivation therapy .

Conditions

Metastatic Prostate Cancer

Locations

  • Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record