TUPKRP Combined With MAB Therapy for LUTS/PCa

Launched by THE THIRD XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Oct 8, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for men with advanced prostate cancer who are experiencing severe urinary problems, known as lower urinary tract symptoms (LUTS). The study will compare two groups of men: one group will receive a combination of a surgical procedure called palliative transurethral plasma kinetic resection of the prostate (p-TUPKRP) along with hormone therapy, while the other group will receive hormone therapy only. The goal is to see if the combination treatment can improve quality of life, urinary symptoms, and overall survival for these patients.

To be eligible for this trial, participants need to be men diagnosed with advanced prostate cancer that is still sensitive to hormone treatment, have severe urinary symptoms (measured by a specific scoring system), and be in good physical health to tolerate the surgery. Participants can expect regular check-ups and assessments throughout the study to monitor their symptoms and overall health. This trial is important because it aims to find better ways to help men with advanced prostate cancer manage debilitating urinary issues and improve their quality of life.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Hormone sensibility advanced prostate adenocarcinoma, clinical stages are T3-4N0-1M0-1b；
• • 2. International prostate symptom score is equal to or greater than 20;
• • 3. Maximum flow rate is equal to or less than 10ml/s, or bladder outlet obstruction is diagnosed by urodynamics
• • 4. Any of the following complication: ① calculus in bladder; ② Recurrent urinary tract infections; ③Inguinal hernia; ④vesicoureteral reflux
• • 5. The physical status score of the Eastern Cancer Cooperative Group (ECOG) is 0 or 1;
• • 6. There has been no previous evidence of malignancy in the past five years.
• • 7. The patient is in good physical condition and able to tolerate anesthesia and surgery;
• • 8. There are no allergic reactions and liver or kidney function damage to endocrine drugs;
• • 9. Ability to take and retain medicines;
• • 10. Ability to follow study visit schedules and other program requirements；
• • 11. Be able to understand the character and purpose of the study, including possible risks and side effects; Be able to work with researchers and follow the requirements of the entire study;
• • 12. Ability to sign and date informed of the full character and purpose of the study, including possible risks and side effects, and sufficient time and opportunity to read and understand the information about this study.
• Exclusion Criteria:
• • 1. Patients with castration-resistant prostate cancer;
• • 2. The physical status score of East Cancer cooperative Group is equal to or greater than 2;
• • 3. There has been previous evidence of other malignancy in the past five years;
• • 4. Patients with high coagulation and cannot stop taking anticoagulants;
• • 5. Abnormal coagulation function such as hemophilia;
• • 6. The patients are in poor physical condition and cannot tolerate anesthesia and surgery;
• • 7. The patients have allergy or toxic side effects and other adverse reaction to endocrine drug;
• • 8. Patients with active tuberculosis or other fulminating infectious disease;
• • 9. Patients with immunodeficiency;
• • 10. Patients with the lower limb and joint function abnormality, cannot maintain the lithotomy position for a long time;
• • 11. Patients with urethral stricture;
• • 12. Unable to comply with study visit schedule and other program requirements;
• • 13. Any patients, who are regarded cannot not participate in the study;