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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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Zhenyu Yang, Dr.
yangzy@sysucc.org.cn
86-1390229060
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2030-03-01
Participants
Target number of participants: 104
Treatments
Experimental: Prostate cryoablation and cyclophosphamide
Metastatic prostate cancer patients receive prostate cryoablation and metronomic cyclophosphamide in addition to androgen deprivation therapy and novel androgen receptor inhibitors.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov