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NCT Number: NCT06854250

Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer

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.

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Key information

Conditions

Metastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510062, China

Location status: Recruiting

Location contact

Zhenyu Yang

CONTACT

[email protected]

86-13902290670

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenyu Yang, Dr.

CONTACT

[email protected]

86-1390229060

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Mar 3, 2025
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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