RecruitingPhase 2NCT06854250

Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer

Androgen Deprivation Therapy Combined With Novel Androgen Receptor Inhibitors, Prostate Cryoablation, and Cyclophosphamide in the Treatment of Newly Diagnosed, Metastatic Prostate Cancer: A Single-Center, Single-Arm, Prospective Clinical Study


Sponsor

Sun Yat-sen University

Enrollment

104 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether freezing the prostate (cryoablation) combined with low-dose chemotherapy (cyclophosphamide) can help the immune system fight metastatic prostate cancer that has spread to other parts of the body. **You may be eligible if:** - You are male, between 18 and 80 years old - You have been diagnosed with metastatic prostate cancer (cancer that has spread beyond the prostate) at initial diagnosis - Your cancer has not progressed at the time treatment is being started - You are in good physical condition and can tolerate general anesthesia and the freezing procedure **You may NOT be eligible if:** - You have a serious illness that makes the treatment too risky - You have had another cancer in the past 5 years (except certain skin cancers) - The cancer has grown into the rectum - Your prostate is still too large (over 55 ml) after 6 months of hormone therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREProstate cryoablation

Enrolled patients will receive prostate cryoablation within 6 months of starting androgen deprivation therapy.

DRUGCyclophosphamide (CTX)

Enrolled patients will receive cyclophosphamide (50mg daily) one day after prostate cryoablation and continue for a total of six months.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06854250


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