Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer (NCT06854250) | Clinical Trial Compass
RecruitingPhase 2
Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer
China104 participantsStarted 2025-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 .
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PSA progression-free survival
Timeframe: 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