NCT06854250 Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer
| NCT ID | NCT06854250 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Metastatic Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2029-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 104 participants in total. It began in 2025-03-01 with a primary completion date of 2029-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 .
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06854250 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Metastatic Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06854250 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06854250 currently recruiting?
Yes, NCT06854250 is actively recruiting participants. Contact the research team at yangzy@sysucc.org.cn for enrollment information.
Where is the NCT06854250 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06854250 clinical trial?
NCT06854250 is sponsored by Sun Yat-sen University. The trial plans to enroll 104 participants.
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