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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 80 Men only

Prostate cryoablation plus low-dose cyclophosphamide with hormonal therapy for metastatic prostate cancer

Official 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

Run by Sun Yat-sen University · NCT06854250 · Data updated 2026-11-12

This trial will test whether adding prostate cryoablation and continuous low-dose cyclophosphamide to standard hormone therapy with a modern androgen receptor blocker helps men with newly diagnosed metastatic prostate cancer live longer without PSA progression.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 80 Years
SexMen only
Enrollment104 (estimated)
SponsorSun Yat-sen University
Academic / other
Drugs / interventionscyclophosphamide
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedMarch 1, 2025
Main results expectedMarch 1, 2029
Study endsMarch 1, 2030
Registry record updatedAugust 28, 2026
Trial IDNCT06854250 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men aged 18–80 with newly diagnosed metastatic prostate acinar adenocarcinoma, ECOG 0–1, able to tolerate general anesthesia and cryoablation, and able to start a novel AR inhibitor within three months of ADT and undergo cryoablation within six months of ADT.

Probably not a fit

Patients unlikely to benefit include those with other recent malignancies, significant comorbid illness, prostate cancer invading the rectum, prior treatments outside the protocol, or prostate volume >55 mL after six months of ADT.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, single-center trial enrolling men with newly diagnosed metastatic prostate acinar adenocarcinoma to receive androgen deprivation therapy plus a novel androgen receptor inhibitor (apalutamide, rezvilutamide, or darolutamide) combined with prostate cryoablation and six months of metronomic cyclophosphamide. Participants should begin the AR inhibitor within three months of starting ADT and undergo cryoablation within six months of ADT initiation, with cyclophosphamide starting one day after cryoablation. The primary endpoint is PSA progression-free survival, while secondary endpoints include radiographic PFS, time to castration-resistant progression, overall survival, PSA nadir, incidence of symptomatic local events, and safety. The trial is conducted at Sun Yat-sen University Cancer Center in Guangzhou, China, and will monitor patients for efficacy and adverse events over follow-up visits.

Why it matters

Potential benefit: If successful, this approach could delay biochemical and clinical progression and reduce local urinary complications, potentially postponing the need for more intensive treatments.

How similar studies have gone: Some prior trials and retrospective series have suggested that treating the primary prostate can improve outcomes in metastatic disease, but combining prostate cryoablation with metronomic cyclophosphamide and modern AR inhibitors is largely novel and not widely tested.

Who can join: the full rules

Show full inclusion / exclusion 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 .

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Metastatic Prostate Cancer 73Cyclophosphamide 119Sun Yat-sen University 344
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.