Prostate cryoablation plus low-dose cyclophosphamide with hormonal therapy 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

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

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Male
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: cyclophosphamide
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06854250 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Zhenyu Yang, Dr.

Conditions Metastatic Prostate Cancer; Metastatic prostate cancer; Novel androgen receptor inhibitors; Prostate cryoablation; Cyclophosphamide