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New treatment option for Metastatic Prostate Cancer
Official title Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT06854250
What this study is testing
What is Cyclophosphamide (CTX)?
Cyclophosphamide (CTX) is an investigational medicine, given as an once-daily, being studied as a potential treatment for metastatic prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- 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;
You likely can't join if
- 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 .
See the full eligibility 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.
- 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 .
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.