Prostate Cryoablation Combined with Metronomic Cyclophosphamide for Metastatic Prostate Cancer

Phase 2

Not yet recruiting

• Conditions: Metastatic Prostate Cancer
• Interventions: Procedure: Prostate cryoablation; Drug: Cyclophosphamide (CTX)

• Registration Number: NCT06854250
• Lead Sponsor: Sun Yat-sen University

Brief 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.

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study Start: 2025-03-01
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Primary Completion: 2029-03-01
• Study Completion: 2030-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostate cryoablation and cyclophosphamide	Prostate cryoablation	Metastatic prostate cancer patients receive prostate cryoablation and metronomic cyclophosphamide in addition to androgen deprivation therapy and novel androgen receptor inhibitors.
Prostate cryoablation and cyclophosphamide	Cyclophosphamide (CTX)	Metastatic prostate cancer patients receive prostate cryoablation and metronomic cyclophosphamide in addition to androgen deprivation therapy and novel androgen receptor inhibitors.

Primary Outcome Measures

Name	Time	Method
PSA progression-free survival	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 Outcome Measures

Name	Time	Method
Radiographic progression-free survival	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.
mCRPC-free survival	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.
Overall survival	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.
Incidence of symptomatic local events	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.