NCT06854250RecruitingPhase 2
Prostate Cryoablation Combined With Metronomic Cyclophosphamide 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
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 20 Feb 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 1 Mar 2029
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Prostate cancer
- NCT number
- NCT06854250
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 104
- From 1 Mar 2025 to the primary completion date, 1 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- with prostate volumegreater than 55ml after 6 months of androgen deprivation therapy .
Other illness
- Serious illness not suitable to receive the treatment regimen;
- Other malignant tumors (within 5 years), except for non-melanoma skin cancer;
- Prostate cancer invading the rectum;
Other
- Receipt of treatments other than treatment regimen of this study;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.