Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer

January 12, 2026 updated by: Yonghong Li, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510062
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prostate cryoablation and cyclophosphamide
Metastatic prostate cancer patients receive prostate cryoablation and metronomic cyclophosphamide in addition to androgen deprivation therapy and novel androgen receptor inhibitors.
Procedure: Prostate cryoablation
Enrolled patients will receive prostate cryoablation within 6 months of starting androgen deprivation therapy.
Drug: Cyclophosphamide (CTX)
Enrolled patients will receive cyclophosphamide (50mg daily) one day after prostate cryoablation and continue for a total of six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA progression-free survival
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
Defined as the time from the initiation of androgen deprivation therapy to the occurrence of PSA progression or death.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic progression-free survival
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
Defined as the time from the initiation of androgen deprivation therapy to the occurrence of radiographic progression of death.
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
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
Defined as the time from the initiation of androgen deprivation therapy to progression to metastatic castration-resistant prostate cancer (mCRPC) or death.
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
Time Frame: From date of initiation of androgen deprivation therapy until the date of death from any cause, assessed up to 5 years
Defined as the time from the initiation of androgen deprivation therapy to death from any cause.
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
Time Frame: Through study completion, an average of 3 year
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.
Through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-FXY-295
  • SL-B2024-623-02 (Other Identifier: Sun Yst-sen University Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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